A Phase 3 interventional study of IncobotulinumtoxinA (Xeomin) and Placebo in Post-stroke Upper Limb Spasticity, sponsored by Merz Pharmaceuticals GmbH. Completed at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-12-15.
Sponsored by Merz Pharmaceuticals GmbH · Phase 3, Interventional, and Treatment
IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free from complexing proteins, i.e. free from proteins other than the active toxin. Injected into the muscle, incobotulinumtoxinA (Xeomin) causes local weakening. Botulinum toxin type A is widely used for treatment of various neurological conditions. This study will investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in the treatment of post-stroke spasticity of the upper limb.
704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.
This study's enrollment of 148 is above the median of 36 across 525 interventional studies indexed under Muscle Spasticity.
Browse Muscle Spasticity studies →Merz Pharmaceuticals GmbH is the lead sponsor of 60 studies on the registry; none are open to participants now.
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Main Inclusion Criteria:
Main Exclusion Criteria:
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), up to five injections in the Open-Label Extension Period, up to 400 units at each injection visit; Mode of administration: intramuscular injection
Drug: IncobotulinumtoxinA (Xeomin)
Drug: Placebo
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), up to five injections in the Open-Label Extension Period, up to 400 units at each injection visit; Mode of administration: intramuscular injection
Placebo
Number of Participants With Reduction of at Least 1 Point at Week 4 Compared to Baseline in Ashworth Score in Wrist Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 4
Responders at Week 4 Based on a Responder Definition of at Least 2 Points Improvement From Baseline in the Ashworth Score for Wrist Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 4
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Wrist Flexors at All Other Post Baseline Visits
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 2, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Elbow Flexors at All Post Baseline Visits
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Forearm Pronators at All Post Baseline Visits
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Finger Flexors at All Post Baseline Visits
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Responders Based on a Responder Definition of at Least 1 Point Improvement From Baseline in the Ashworth Score for Treated Thumb Flexors at All Post Baseline Visits
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Change From Baseline to Week 2 in Ashworth Scale Score for Treated Elbow Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 2
Change From Baseline to Week 4 in Ashworth Scale Score for Treated Elbow Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 4
Change From Baseline to Week 8 in Ashworth Scale Score for Treated Elbow Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 8
Change From Baseline to Week 12 in Ashworth Scale Score for Treated Elbow Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 12
Change From Baseline to Final Visit in Ashworth Scale Score for Treated Elbow Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Change From Baseline to Week 2 in Ashworth Scale Score for Treated Forearm Pronators
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 2
Change From Baseline to Week 4 in Ashworth Scale Score for Treated Forearm Pronators
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 4
Change From Baseline to Week 8 in Ashworth Scale Score for Treated Forearm Pronators
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 8
Change From Baseline to Week 12 in Ashworth Scale Score for Treated Forearm Pronators
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 12
Change From Baseline to Final Visit in Ashworth Scale Score for Treated Forearm Pronators
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Change From Baseline to Week 2 in Ashworth Scale Score for Wrist Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 2
Change From Baseline to Week 4 in Ashworth Scale Score for Wrist Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 4
Change From Baseline to Week 8 in Ashworth Scale Score for Wrist Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 8
Change From Baseline to Week 12 in Ashworth Scale Score for Wrist Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 12
Change From Baseline to Final Visit in Ashworth Scale Score for Wrist Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Change From Baseline to Week 2 in Ashworth Scale Score for Finger Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 2
Change From Baseline to Week 4 in Ashworth Scale Score for Finger Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 4
Change From Baseline to Week 8 in Ashworth Scale Score for Finger Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 8
Change From Baseline to Week 12 in Ashworth Scale Score for Finger Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 12
Change From Baseline to Final Visit in Ashworth Scale Score for Finger Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Change From Baseline to Week 2 in Ashworth Scale Score for Treated Thumb Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 2
Change From Baseline to Week 4 in Ashworth Scale Score for Treated Thumb Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 4
Change From Baseline to Week 8 in Ashworth Scale Score for Treated Thumb Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 8
Change From Baseline to Week 12 in Ashworth Scale Score for Treated Thumb Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Week 12
Change From Baseline to Final Visit in Ashworth Scale Score for Treated Thumb Flexors
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
Time frame: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Time to Onset of Treatment Effect
Starting with the visit 2 weeks after baseline injection the subject was asked if he/she experienced an treatment effect and if "yes": when. If the subject did not experience an treatment effect he/she was asked again at each of the following visits (at week 4, 8, and 12) of the Main Period until the answer was "yes" or until the final visit of the Main Period was performed. For subjects without any treatment effect the time to onset of effect was censored at the last visit of the Main Period.
Time frame: Period starting at Visit 2 (baseline injection) of the Main Period up to onset of treatment effect
Time to Waning of Treatment Effect
Subject who reported an onset of treatment effect were asked at each visit/telephone contact starting at week 4 at earliest if he/she felt that there was a waning of the treatment effect. The same question was asked at each of the following telephone contacts and visits (up to the Final Visit of the Main Period) if the answer at the respective previous visit was "no". If the patient answered with "yes" he/she will be asked at which week after the injection (= the time span in weeks) the waning of effect occurred. For all subjects without an onset of treatment effect the waning was set to zero.
Time frame: Defined as time (weeks) from Visit 2 (injection session at Baseline, Day 0) to the subjective estimation of the waning of the effect
Duration of Treatment Effect
The duration of treatment effect is defined as the time period from the day of injection until the time point of a need for a new injection agreed by the patient and the investigator. For subjects without any treatment effect the duration of effect was set to zero.
Time frame: Period from the day of injection until the time point of a need for a new injection agreed by the patient and the investigator
Investigator's Global Assessment of Efficacy
The Investigator's Global Assessment of Efficacy is a subjective estimation assessed on a 4-point Likert scale with the items 1=very good, 2=good, 3=moderate, and 4=poor.
Time frame: Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Patient's Global Assessment of Efficacy
The Patient's Global Assessment of Efficacy is a subjective estimation assessed on a 4-point Likert scale with the items 1=very good, 2=good, 3=moderate, and 4=poor.
Time frame: Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Carer's Global Assessment of Efficacy
The Carer's Global Assessment of Efficacy is a subjective estimation assessed on a 4-point Likert scale with the items 1=very good, 2=good, 3=moderate, and 4=poor.
Time frame: Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Change From Baseline to Week 2 in the Disability Assessment Scale for the Principal Therapeutic Target
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Baseline, Week 2
Change From Baseline to Week 4 in the Disability Assessment Scale for the Principal Therapeutic Target
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Baseline, Week 4
Change From Baseline to Week 8 in the Disability Assessment Scale for the Principal Therapeutic Target
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Baseline, Week 8
Change From Baseline to Week 12 in the Disability Assessment Scale for the Principal Therapeutic Target
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Baseline, Week 12
Change From Baseline to Final Visit in the Disability Assessment Scale for the Principal Therapeutic Target
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Hygiene"
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Baseline, Week 2
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Hygiene"
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Baseline, Week 4
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Hygiene"
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Baseline, Week 8
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Hygiene"
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Baseline, Week 12
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Hygiene"
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Dressing"
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Baseline, Week 2
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Dressing"
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Baseline, Week 4
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Dressing"
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Baseline, Week 8
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Dressing"
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Baseline, Week 12
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Dressing"
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Limb Position"
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Baseline, Week 2
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Limb Position"
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Baseline, Week 4
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Limb Position"
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Baseline, Week 8
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Limb Position"
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Baseline, Week 12
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Limb Position"
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Change From Baseline to Week 2 in the Disability Assessment Scale for Domain "Pain"
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Baseline, Week 2
Change From Baseline to Week 4 in the Disability Assessment Scale for Domain "Pain"
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Baseline, Week 4
Change From Baseline to Week 8 in the Disability Assessment Scale for Domain "Pain"
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Baseline, Week 8
Change From Baseline to Week 12 in the Disability Assessment Scale for Domain "Pain"
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Baseline, Week 12
Change From Baseline to Final Visit in the Disability Assessment Scale for Domain "Pain"
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
Time frame: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand"
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, Week 4
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand"
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, Week 12
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cleaning the Palm of the Affected Hand"
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand"
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, Week 4
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand"
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, Week 12
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cutting the Fingernails of the Affected Hand"
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm"
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, Week 4
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm"
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, Week 12
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Cleaning the Armpit of the Affected Arm"
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)"
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, Week 4
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)"
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, Week 12
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Putting the Affected Arm Through the Sleeve (e.g., Coat, Shirt, Jacket)"
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Change From Baseline to Week 4 in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm"
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, Week 4
Change From Baseline to Week 12 in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm"
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, Week 12
Change From Baseline to Final Visit in the Carer Burden Scale for Domain "Applying a Splint on the Affected Arm"
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
Time frame: Baseline, Final Visit of the Main Period (to be performed at week 12 after 1st injection at earliest, at week 20 at latest)
Onset of Treatment Effect [Classified]
Starting with the visit 2 weeks after baseline injection the subject was asked if he/she experienced an treatment effect and if "yes": when. If the subject did not experience an treatment effect he/she was asked again at each of the following visits (at week 4, 8, and 12) of the Main Period until the answer was "yes" or until the final visit of the Main Period was performed. For subjects without any treatment effect the time to onset of effect was censored at the last visit of the Main Period.
Time frame: Period starting at baseline injection of the Main Period up to onset of treatment effect
| Milestone | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Started | 73 | 75 |
| Completed | 71 | 74 |
| Not completed | 2 | 1 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Consent withdrawn | 1 | 0 |
| Milestone | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Started | 145 | 0 |
| Completed | 120 | 0 |
| Not completed | 25 | 0 |
| Withdrew: Withdrawal criteria occurred | 1 | 0 |
| Withdrew: Lack of efficacy | 6 | 0 |
| Withdrew: Adverse event | 5 | 0 |
| Withdrew: Consent withdrawn | 10 | 0 |
| Withdrew: Physician decision | 3 | 0 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Number of Participants With Reduction of at Least 1 Point at Week 4 Compared to Baseline in Ashworth Score in Wrist Flexors | 50 | 28 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Responders at Week 4 Based on a Responder Definition of at Least 2 Points Improvement From Baseline in the Ashworth Score for Wrist Flexors | 14 | 3 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Week 2 | 45 | 22 |
| Week 8 | 49 | 22 |
| Week 12 | 31 | 18 |
| Final Visit | 29 | 14 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Week 2 | 32 | 15 |
| Week 4 | 34 | 21 |
| Week 8 | 27 | 22 |
| Week 12 | 23 | 16 |
| Final Visit | 21 | 14 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Week 2 | 16 | 10 |
| Week 4 | 19 | 12 |
| Week 8 | 18 | 11 |
| Week 12 | 12 | 11 |
| Final Visit | 10 | 9 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Week 2 | 50 | 22 |
| Week 4 | 50 | 27 |
| Week 8 | 44 | 27 |
| Week 12 | 35 | 23 |
| Final Visit | 28 | 17 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Week 2 | 16 | 8 |
| Week 4 | 17 | 11 |
| Week 8 | 14 | 14 |
| Week 12 | 14 | 10 |
| Final Visit | 11 | 10 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 0 | 0 |
| Change of "-2" points | 5 | 0 |
| Change of "-1" points | 27 | 15 |
| Change of "0" points | 22 | 39 |
| Change of "+1" points | 0 | 1 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 0 | 0 |
| Change of "-2" points | 5 | 1 |
| Change of "-1" points | 29 | 20 |
| Change of "0" points | 20 | 32 |
| Change of "+1" points | 0 | 2 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 1 | 0 |
| Change of "-2" points | 6 | 2 |
| Change of "-1" points | 20 | 20 |
| Change of "0" points | 26 | 31 |
| Change of "+1" points | 0 | 2 |
| Missing | 1 | 0 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 0 | 0 |
| Change of "-2" points | 5 | 0 |
| Change of "-1" points | 18 | 16 |
| Change of "0" points | 31 | 36 |
| Change of "+1" points | 0 | 2 |
| Missing | 0 | 1 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 0 | 0 |
| Change of "-2" points | 2 | 0 |
| Change of "-1" points | 19 | 14 |
| Change of "0" points | 32 | 37 |
| Change of "+1" points | 1 | 3 |
| Missing | 0 | 1 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 0 | 0 |
| Change of "-2" points | 3 | 0 |
| Change of "-1" points | 13 | 10 |
| Change of "0" points | 18 | 27 |
| Change of "+1" points | 1 | 1 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 1 | 0 |
| Change of "-2" points | 2 | 0 |
| Change of "-1" points | 16 | 12 |
| Change of "0" points | 16 | 24 |
| Change of "+1" points | 0 | 1 |
| Missing | 0 | 1 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 1 | 0 |
| Change of "-2" points | 2 | 0 |
| Change of "-1" points | 15 | 11 |
| Change of "0" points | 16 | 25 |
| Change of "+1" points | 1 | 1 |
| Missing | 0 | 1 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 0 | 0 |
| Change of "-2" points | 2 | 0 |
| Change of "-1" points | 10 | 11 |
| Change of "0" points | 21 | 20 |
| Change of "+1" points | 1 | 5 |
| Missing | 1 | 2 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 0 | 0 |
| Change of "-2" points | 1 | 1 |
| Change of "-1" points | 9 | 8 |
| Change of "0" points | 22 | 21 |
| Change of "+1" points | 2 | 6 |
| Missing | 1 | 2 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 1 | 0 |
| Change of "-2" points | 11 | 2 |
| Change of "-1" points | 33 | 20 |
| Change of "0" points | 27 | 51 |
| Change of "+1" points | 1 | 0 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 1 | 0 |
| Change of "-2" points | 13 | 3 |
| Change of "-1" points | 36 | 25 |
| Change of "0" points | 22 | 41 |
| Change of "+1" points | 1 | 3 |
| Missing | 0 | 1 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 1 | 0 |
| Change of "-2" points | 13 | 4 |
| Change of "-1" points | 35 | 18 |
| Change of "0" points | 21 | 47 |
| Change of "+1" points | 2 | 3 |
| Missing | 1 | 1 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 1 | 0 |
| Change of "-2" points | 9 | 2 |
| Change of "-1" points | 21 | 16 |
| Change of "0" points | 38 | 47 |
| Change of "+1" points | 2 | 6 |
| Missing | 2 | 2 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 0 | 0 |
| Change of "-2" points | 2 | 0 |
| Change of "-1" points | 27 | 14 |
| Change of "0" points | 39 | 50 |
| Change of "+1" points | 4 | 7 |
| Missing | 1 | 2 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 4 | 0 |
| Change of "-2" points | 8 | 2 |
| Change of "-1" points | 38 | 20 |
| Change of "0" points | 21 | 50 |
| Change of "+1" points | 2 | 3 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 5 | 0 |
| Change of "-2" points | 15 | 5 |
| Change of "-1" points | 30 | 22 |
| Change of "0" points | 22 | 44 |
| Change of "+1" points | 1 | 3 |
| Missing | 0 | 1 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 2 | 0 |
| Change of "-2" points | 18 | 3 |
| Change of "-1" points | 24 | 24 |
| Change of "0" points | 27 | 43 |
| Change of "+1" points | 1 | 4 |
| Missing | 1 | 1 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 2 | 0 |
| Change of "-2" points | 9 | 2 |
| Change of "-1" points | 24 | 21 |
| Change of "0" points | 33 | 45 |
| Change of "+1" points | 3 | 5 |
| Missing | 2 | 2 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 0 | 0 |
| Change of "-2" points | 2 | 1 |
| Change of "-1" points | 26 | 16 |
| Change of "0" points | 39 | 51 |
| Change of "+1" points | 5 | 5 |
| Missing | 1 | 2 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 0 | 0 |
| Change of "-2" points | 3 | 1 |
| Change of "-1" points | 13 | 7 |
| Change of "0" points | 10 | 22 |
| Change of "+1" points | 0 | 1 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 0 | 0 |
| Change of "-2" points | 6 | 2 |
| Change of "-1" points | 11 | 9 |
| Change of "0" points | 9 | 18 |
| Change of "+1" points | 0 | 1 |
| Missing | 0 | 1 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 0 | 0 |
| Change of "-2" points | 6 | 2 |
| Change of "-1" points | 8 | 12 |
| Change of "0" points | 11 | 15 |
| Change of "+1" points | 1 | 0 |
| Change of "+2" points | 0 | 1 |
| Missing | 0 | 1 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 0 | 1 |
| Change of "-2" points | 4 | 1 |
| Change of "-1" points | 10 | 8 |
| Change of "0" points | 11 | 14 |
| Change of "+1" points | 0 | 4 |
| Change of "+2" points | 0 | 1 |
| Missing | 1 | 2 |
The Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the primary efficacy analysis.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 0 | 1 |
| Change of "-2" points | 2 | 0 |
| Change of "-1" points | 9 | 9 |
| Change of "0" points | 13 | 14 |
| Change of "+1" points | 1 | 4 |
| Change of "+2" points | 0 | 1 |
| Missing | 1 | 2 |
Starting with the visit 2 weeks after baseline injection the subject was asked if he/she experienced an treatment effect and if "yes": when. If the subject did not experience an treatment effect he/she was asked again at each of the following visits (at week 4, 8, and 12) of the Main Period until the answer was "yes" or until the final visit of the Main Period was performed. For subjects without any treatment effect the time to onset of effect was censored at the last visit of the Main Period.
| Days | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Time to Onset of Treatment Effect | 4.0 (3.0 to 7.0) | — |
Subject who reported an onset of treatment effect were asked at each visit/telephone contact starting at week 4 at earliest if he/she felt that there was a waning of the treatment effect. The same question was asked at each of the following telephone contacts and visits (up to the Final Visit of the Main Period) if the answer at the respective previous visit was "no". If the patient answered with "yes" he/she will be asked at which week after the injection (= the time span in weeks) the waning of effect occurred. For all subjects without an onset of treatment effect the waning was set to zero.
| Weeks | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Time to Waning of Treatment Effect | 10.0 (9.0 to 11.0) | 10.0 (10.0 to 11.0) |
The duration of treatment effect is defined as the time period from the day of injection until the time point of a need for a new injection agreed by the patient and the investigator. For subjects without any treatment effect the duration of effect was set to zero.
| Days | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Duration of Treatment Effect | 87.0 (86.0 to 94.0) | 84.0 (0.0 to 84.0) |
Starting with the visit 2 weeks after baseline injection the subject was asked if he/she experienced an treatment effect and if "yes": when. If the subject did not experience an treatment effect he/she was asked again at each of the following visits (at week 4, 8, and 12) of the Main Period until the answer was "yes" or until the final visit of the Main Period was performed. For subjects without any treatment effect the time to onset of effect was censored at the last visit of the Main Period.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Onset at Day 1, 2 or 3 | 32 | 14 |
| Onset at Day 4, 5 or 6 | 12 | 4 |
| Onset at Day 7, 8 or 9 | 9 | 11 |
| Onset at Day 10, 11 or 12 | 1 | 6 |
| Onset at Day 13, 14 or 15 | 3 | 1 |
| Onset at Day 16, 17 or 18 | 1 | 1 |
| Onset at Day 19, 20 or 21 | 3 | 3 |
| Onset at Day 22, 23 or 24 | 0 | 2 |
| Onset later than Day 25 | 2 | 1 |
| Censored | 10 | 32 |
The Investigator's Global Assessment of Efficacy is a subjective estimation assessed on a 4-point Likert scale with the items 1=very good, 2=good, 3=moderate, and 4=poor.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Very good | 11 | 2 |
| Good | 32 | 24 |
| Moderate | 14 | 12 |
| Poor | 15 | 35 |
| Missing | 1 | 2 |
The Patient's Global Assessment of Efficacy is a subjective estimation assessed on a 4-point Likert scale with the items 1=very good, 2=good, 3=moderate, and 4=poor.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Very good | 7 | 2 |
| Good | 41 | 21 |
| Moderate | 9 | 17 |
| Poor | 15 | 33 |
| Missing | 1 | 2 |
The Carer's Global Assessment of Efficacy is a subjective estimation assessed on a 4-point Likert scale with the items 1=very good, 2=good, 3=moderate, and 4=poor.
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Very good | 8 | 2 |
| Good | 21 | 17 |
| Moderate | 9 | 10 |
| Poor | 8 | 24 |
| No carer | 26 | 19 |
| Missing | 1 | 3 |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 1 | 0 |
| Change of "-2" points | 7 | 1 |
| Change of "-1" points | 21 | 8 |
| Change of "0" points | 43 | 66 |
| Change of "+1" points | 2 | 0 |
| Change of "+2" points | 0 | 0 |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 0 | 0 |
| Change of "-2" points | 12 | 1 |
| Change of "-1" points | 21 | 15 |
| Change of "0" points | 40 | 57 |
| Change of "+1" points | 1 | 1 |
| Change of "+2" points | 0 | 0 |
| Missing | 0 | 1 |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 1 | 0 |
| Change of "-2" points | 6 | 1 |
| Change of "-1" points | 26 | 15 |
| Change of "0" points | 37 | 57 |
| Change of "+1" points | 2 | 1 |
| Change of "+2" points | 0 | 0 |
| Missing | 2 | 1 |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 1 | 0 |
| Change of "-2" points | 3 | 2 |
| Change of "-1" points | 24 | 10 |
| Change of "0" points | 42 | 58 |
| Change of "+1" points | 2 | 3 |
| Change of "+2" points | 0 | 0 |
| Missing | 2 | 2 |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 0 | 0 |
| Change of "-2" points | 2 | 1 |
| Change of "-1" points | 20 | 14 |
| Change of "0" points | 47 | 55 |
| Change of "+1" points | 2 | 3 |
| Change of "+2" points | 1 | 0 |
| Missing | 2 | 2 |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 2 | 0 |
| Change of "-2" points | 6 | 1 |
| Change of "-1" points | 12 | 7 |
| Change of "0" points | 52 | 66 |
| Change of "+1" points | 1 | 1 |
| Change of "+2" points | 0 | 0 |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 3 | 0 |
| Change of "-2" points | 5 | 1 |
| Change of "-1" points | 14 | 11 |
| Change of "0" points | 48 | 59 |
| Change of "+1" points | 3 | 3 |
| Change of "+2" points | 0 | 0 |
| Missing | 0 | 1 |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 2 | 0 |
| Change of "-2" points | 6 | 1 |
| Change of "-1" points | 16 | 12 |
| Change of "0" points | 44 | 58 |
| Change of "+1" points | 3 | 3 |
| Change of "+2" points | 0 | 0 |
| Missing | 2 | 1 |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 1 | 0 |
| Change of "-2" points | 4 | 1 |
| Change of "-1" points | 11 | 12 |
| Change of "0" points | 50 | 53 |
| Change of "+1" points | 4 | 7 |
| Change of "+2" points | 1 | 0 |
| Missing | 2 | 2 |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 1 | 1 |
| Change of "-2" points | 2 | 1 |
| Change of "-1" points | 10 | 9 |
| Change of "0" points | 50 | 53 |
| Change of "+1" points | 6 | 9 |
| Change of "+2" points | 2 | 0 |
| Missing | 2 | 2 |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 1 | 0 |
| Change of "-2" points | 3 | 0 |
| Change of "-1" points | 16 | 5 |
| Change of "0" points | 51 | 69 |
| Change of "+1" points | 2 | 1 |
| Change of "+2" points | 0 | 0 |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 0 | 0 |
| Change of "-2" points | 5 | 2 |
| Change of "-1" points | 12 | 15 |
| Change of "0" points | 53 | 54 |
| Change of "+1" points | 3 | 3 |
| Change of "+2" points | 0 | 0 |
| Missing | 0 | 1 |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 1 | 0 |
| Change of "-2" points | 3 | 2 |
| Change of "-1" points | 16 | 13 |
| Change of "0" points | 48 | 56 |
| Change of "+1" points | 3 | 3 |
| Change of "+2" points | 0 | 0 |
| Missing | 2 | 1 |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 1 | 0 |
| Change of "-2" points | 3 | 3 |
| Change of "-1" points | 16 | 13 |
| Change of "0" points | 47 | 53 |
| Change of "+1" points | 4 | 4 |
| Change of "+2" points | 0 | 0 |
| Missing | 2 | 2 |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 0 | 0 |
| Change of "-2" points | 2 | 2 |
| Change of "-1" points | 14 | 16 |
| Change of "0" points | 50 | 51 |
| Change of "+1" points | 5 | 4 |
| Change of "+2" points | 0 | 0 |
| Missing | 2 | 2 |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 1 | 0 |
| Change of "-2" points | 2 | 0 |
| Change of "-1" points | 22 | 8 |
| Change of "0" points | 43 | 65 |
| Change of "+1" points | 5 | 2 |
| Change of "+2" points | 0 | 0 |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 0 | 0 |
| Change of "-2" points | 7 | 1 |
| Change of "-1" points | 25 | 10 |
| Change of "0" points | 37 | 59 |
| Change of "+1" points | 4 | 4 |
| Change of "+2" points | 0 | 0 |
| Missing | 0 | 1 |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 0 | 0 |
| Change of "-2" points | 4 | 1 |
| Change of "-1" points | 26 | 10 |
| Change of "0" points | 37 | 61 |
| Change of "+1" points | 4 | 2 |
| Change of "+2" points | 0 | 0 |
| Missing | 2 | 1 |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 0 | 0 |
| Change of "-2" points | 3 | 3 |
| Change of "-1" points | 19 | 9 |
| Change of "0" points | 45 | 56 |
| Change of "+1" points | 3 | 5 |
| Change of "+2" points | 1 | 0 |
| Missing | 2 | 2 |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 0 | 0 |
| Change of "-2" points | 1 | 3 |
| Change of "-1" points | 22 | 14 |
| Change of "0" points | 42 | 51 |
| Change of "+1" points | 5 | 5 |
| Change of "+2" points | 1 | 0 |
| Missing | 2 | 2 |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 1 | 0 |
| Change of "-2" points | 3 | 0 |
| Change of "-1" points | 12 | 5 |
| Change of "0" points | 54 | 69 |
| Change of "+1" points | 3 | 0 |
| Change of "+2" points | 0 | 1 |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 2 | 0 |
| Change of "-2" points | 8 | 2 |
| Change of "-1" points | 11 | 4 |
| Change of "0" points | 46 | 67 |
| Change of "+1" points | 6 | 1 |
| Change of "+2" points | 0 | 0 |
| Missing | 0 | 1 |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 2 | 0 |
| Change of "-2" points | 4 | 1 |
| Change of "-1" points | 11 | 7 |
| Change of "0" points | 49 | 65 |
| Change of "+1" points | 5 | 0 |
| Change of "+2" points | 0 | 1 |
| Missing | 2 | 1 |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 3 | 0 |
| Change of "-2" points | 3 | 1 |
| Change of "-1" points | 10 | 9 |
| Change of "0" points | 52 | 62 |
| Change of "+1" points | 3 | 0 |
| Change of "+2" points | 0 | 1 |
| Missing | 2 | 2 |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Change of "-3" points | 2 | 0 |
| Change of "-2" points | 3 | 2 |
| Change of "-1" points | 11 | 7 |
| Change of "0" points | 51 | 63 |
| Change of "+1" points | 4 | 0 |
| Change of "+2" points | 0 | 1 |
| Missing | 2 | 2 |
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| No carer | 26 | 20 |
| No longer necessary | 3 | 0 |
| Less difficult | 15 | 9 |
| Unchanged | 24 | 38 |
| More difficult | 5 | 4 |
| Required for the first time | 0 | 3 |
| Missing | 0 | 1 |
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| No carer | 26 | 22 |
| No longer necessary | 2 | 1 |
| Less difficult | 12 | 4 |
| Unchanged | 26 | 38 |
| More difficult | 7 | 5 |
| Required for the first time | 0 | 3 |
| Missing | 0 | 2 |
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| No carer | 27 | 22 |
| No longer necessary | 2 | 0 |
| Less difficult | 8 | 4 |
| Unchanged | 26 | 36 |
| More difficult | 9 | 5 |
| Required for the first time | 1 | 6 |
| Missing | 0 | 2 |
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| No carer | 26 | 20 |
| No longer necessary | 0 | 0 |
| Less difficult | 17 | 12 |
| Unchanged | 19 | 36 |
| More difficult | 11 | 5 |
| Required for the first time | 0 | 1 |
| Missing | 0 | 1 |
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| No carer | 26 | 22 |
| No longer necessary | 1 | 0 |
| Less difficult | 12 | 15 |
| Unchanged | 21 | 26 |
| More difficult | 13 | 9 |
| Required for the first time | 0 | 1 |
| Missing | 0 | 2 |
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| No carer | 27 | 22 |
| No longer necessary | 1 | 1 |
| Less difficult | 12 | 12 |
| Unchanged | 21 | 26 |
| More difficult | 12 | 10 |
| Required for the first time | 0 | 2 |
| Missing | 0 | 2 |
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| No carer | 26 | 20 |
| No longer necessary | 3 | 0 |
| Less difficult | 11 | 8 |
| Unchanged | 27 | 38 |
| More difficult | 4 | 6 |
| Required for the first time | 2 | 2 |
| Missing | 0 | 1 |
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| No carer | 26 | 22 |
| No longer necessary | 1 | 2 |
| Less difficult | 12 | 7 |
| Unchanged | 25 | 33 |
| More difficult | 6 | 8 |
| Required for the first time | 3 | 1 |
| Missing | 0 | 2 |
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| No carer | 27 | 22 |
| No longer necessary | 1 | 2 |
| Less difficult | 12 | 6 |
| Unchanged | 23 | 32 |
| More difficult | 6 | 9 |
| Required for the first time | 4 | 2 |
| Missing | 0 | 2 |
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| No carer | 26 | 20 |
| No longer necessary | 2 | 1 |
| Less difficult | 18 | 11 |
| Unchanged | 25 | 36 |
| More difficult | 2 | 4 |
| Required for the first time | 0 | 2 |
| Missing | 0 | 1 |
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| No carer | 26 | 22 |
| No longer necessary | 2 | 3 |
| Less difficult | 17 | 13 |
| Unchanged | 24 | 28 |
| More difficult | 4 | 6 |
| Required for the first time | 0 | 1 |
| Missing | 0 | 2 |
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| No carer | 27 | 22 |
| No longer necessary | 3 | 4 |
| Less difficult | 16 | 10 |
| Unchanged | 24 | 29 |
| More difficult | 3 | 6 |
| Required for the first time | 0 | 2 |
| Missing | 0 | 2 |
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| No carer | 26 | 20 |
| No longer necessary | 1 | 1 |
| Less difficult | 5 | 1 |
| Unchanged | 40 | 51 |
| More difficult | 1 | 0 |
| Required for the first time | 0 | 1 |
| Missing | 0 | 1 |
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| No carer | 26 | 22 |
| No longer necessary | 2 | 1 |
| Less difficult | 2 | 2 |
| Unchanged | 42 | 46 |
| More difficult | 1 | 0 |
| Required for the first time | 0 | 2 |
| Missing | 0 | 2 |
The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It consists of the following items: A=cleaning the palm of the affected hand; B=cutting the fingernails of the affected hand; C=Cleaning the armpit of the affected arm; D=putting the affected arm through the sleeve; E=applying a splint on the affected arm. Each item was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).
| Participants | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| No carer | 27 | 22 |
| No longer necessary | 3 | 1 |
| Less difficult | 1 | 2 |
| Unchanged | 41 | 45 |
| More difficult | 1 | 1 |
| Required for the first time | 0 | 2 |
| Missing | 0 | 2 |
Collected over All SAEs/AEs during Double-Blind Period After Injection.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| incobotulinumtoxinA (Xeomin) | — | 4/73 (5.5%) | 10/73 (13.7%) |
| Placebo | — | 1/75 (1.3%) | 5/75 (6.7%) |
| Event | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| Bronchitis chronicRespiratory, thoracic and mediastinal disorders | 1/73 | 0/75 |
| CellulitisInfections and infestations | 1/73 | 0/75 |
| EpilepsyNervous system disorders | 1/73 | 0/75 |
| HypertensionVascular disorders | 1/73 | 0/75 |
| ParaparesisNervous system disorders | 1/73 | 0/75 |
| Status epilepticusNervous system disorders | 1/73 | 0/75 |
| VertigoEar and labyrinth disorders | 1/73 | 0/75 |
| Intracranial haematomaNervous system disorders | 0/73 | 1/75 |
| Event | incobotulinumtoxinA (Xeomin) | Placebo |
|---|---|---|
| HyperglycaemiaMetabolism and nutrition disorders | 3/73 | 0/75 |
| DiarrhoeaGastrointestinal disorders | 2/73 | 2/75 |
| EpilepsyNervous system disorders | 2/73 | 0/75 |
| HeadacheNervous system disorders | 2/73 | 1/75 |
| HypercholesterolaemiaMetabolism and nutrition disorders | 2/73 | 1/75 |
| ContusionInjury, poisoning and procedural complications | 1/73 | 2/75 |
| VomitingGastrointestinal disorders | 0/73 | 2/75 |
| Age Continuous(years) | incobotulinumtoxinA (Xeomin) | Placebo | Total |
|---|---|---|---|
| Mean | 58.1 ± 10.2 | 53.3 ± 13.3 | 55.6 ± 12.1 |
| Sex: Female, Male(Participants) | incobotulinumtoxinA (Xeomin) | Placebo | Total |
|---|---|---|---|
| Female | 28 | 25 | 53 |
| Male | 45 | 50 | 95 |
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