A Phase 3 interventional study of IncobotulinumtoxinA in Spasticity of the Upper and Lower Limb Due to Cerebral Causes, sponsored by Merz Pharmaceuticals GmbH. Completed at 33 sites in 8 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-04-26.
Sponsored by Merz Pharmaceuticals GmbH · Phase 3, Interventional, and Treatment
The purpose of this study is to determine whether injections with increasing doses (up to 800 units) of Botulinum toxin type A into muscles of the leg and/or arm are safe and effective in treating patients with spasticity on one body side due to cerebral causes.
A dose-titration approach will be used over three injection cycles, with a flexible observation period after injections of 12-16 weeks and a total duration of up to 48 weeks. Cycle 1 and 2: upper and/or lower limb to be treated; Cycle 3: upper and lower limb to be treated.
704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.
This study's enrollment of 155 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.
Counted across the registry records on this site, refreshed daily.
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
Drug: IncobotulinumtoxinA
Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units. For each injection session: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 mL per 100 units; Mode of administration: intramuscular injection.
Occurrence of Treatment-Emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the Administration of Study Medication
Treatment-emergent Adverse Events (TEASs) are events observed from the time point of first injection until 16 weeks after last injection. Values reported here refer to the number of subjects affected.
Time frame: From baseline to week 36-48
Investigator's Global Assessment of Tolerability in Subjects
A 4-point Likert scale was used with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor.
Time frame: Up to Week 48
Ashworth Scale (AS) Scores of the Target Joint Selected at Study Baseline Visit
The AS 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).
Time frame: From Cycle Baseline to Week 4 of Each Cycle
Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Injection Cycle Baseline Visits to Respective Control Visits
The AS 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).
Time frame: From Cycle Baseline to Week 4 of Each Cycle
Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Study Baseline Visit to Control Visits of Injection Cycles
The AS 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).
Time frame: From Study Baseline to Week 4, 16-20 and 28-36
Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit
The AS 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).
Time frame: From Study Baseline to Week 12-16, 24-32 and 36-48
Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity
Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS 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).
Time frame: From Cycle Baseline to Week 4 of Each Cycle
Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits
Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS 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).
Time frame: From Cycle Baseline to Week 4 of Each Cycle
Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles
Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS 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).
Time frame: From Study Baseline to Week 4, 16-20 and 28-36
Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit
Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS 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).
Time frame: From Study Baseline to Week 12-16, 24-32 and 36-48
Resistance to Passive Movement Scale (REPAS) Scores of Treated Side
The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52.
Time frame: From Cycle Baseline to Week 4 of Each Cycle
Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Injection Cycle Baseline Visits to Respective Control Visits
The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52.
Time frame: From Cycle Baseline to Week 4 of Each Cycle
Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Study Baseline Visit to Control Visits of Injection Cycles
The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52.
Time frame: From Study Baseline to Week 4, 16-20 and 28-36
Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit
The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52.
Time frame: From Study Baseline to Week 12-16, 24-32 and 36-48
Functional Ambulation Classification (FAC) Scale Scores
The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent.
Time frame: From Cycle Baseline to Week 4 of Each Cycle
Change of Functional Ambulation Classification (FAC) Score From Injection Cycle Baseline Visits to Respective Control Visits
The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent.
Time frame: From Cycle Baseline to Week 4 of Each Cycle
Change of Functional Ambulation Classification (FAC) Score From Study Baseline Visit to Control Visits of Injection Cycles
The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent.
Time frame: From Study Baseline to Week 4, 16-20 and 28-36
Change of Functional Ambulation Classification (FAC) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit
The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent.
Time frame: From Study Baseline to Week 12-16, 24-32 and 36-48
Goal Attainment Scale (GAS) Scores for Upper and Lower Limb, Respectively
Change in goal attainment T-scores from respective injection cycle baseline visit. GAS measures the extent to which subject's individual goals are achieved in course of intervention. Subject and treating team have to identify 2 personal goals for each treated limb at each injection cycle. Investigator rates the GAS score for each injection cycle. Degree of goal attainment is rated on 5-point scale (-2, -1, 0, +1, +2; study baseline set to -1) and in order to account for interindividual differences in the number of goals, ratings are computed with the Kiresuk formula (Kiresuk \& Sherman, Community Mental Health Journal. 1968;4(6):443-53) resulting in T-scores measuring the degree of goal attainment at each visit. A score of 50 indicates that the individual has reached the expected level of achievement for all goals. The size of change from measurement to measurement indicates incremental change towards or away from goal attainment. Positive values indicate a higher goal attainment.
Time frame: From Cycle Baseline Visit to Week 12-16, 24-32 and 36-48
Disability Assessment Scale (DAS) Scores in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value.
Time frame: From Cycle Baseline to Week 4 of Each Cycle
Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Injection Cycle Baseline Visits to Respective Control Visits
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value change.
Time frame: Week 4 of Each Cycle
Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Study Baseline Visit to Control Visits of Injection Cycles
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value change.
Time frame: From Study Baseline to Week 4, 16-20 and 28-36
Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit.
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value change.
Time frame: From Study Baseline to Week 12-16, 24-32 and 36-48
Global Assessment of Efficacy Scores
Investigator assessment. The global assessment of efficacy will be assessed by the investigator, the subject, and the caregiver using a 4-point Likert scale with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor.
Time frame: Week 12-16, 24-32 and 36-48
EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject's health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems.
Time frame: From Cycle Baseline to Week 4 of Each Cycle
Visual Analogue Scale (VAS) of EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values represent better outcome).
Time frame: From Cycle Baseline to Week 4 of Each Cycle
Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject's health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Frequency -2/-1= improvement by two/one categories; 0 = no change; +1/+2 worsening by one/two categories.
Time frame: From Cycle Baseline to Week 4 of Each Cycle
Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values represent better outcome).
Time frame: From Cycle Baseline to Week 4 of Each Cycle
Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject's health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Frequency -2/-1= improvement by two/one categories; 0 = no change; +1/+2 worsening by one/two categories.
Time frame: From Study Baseline to Week 4, 16-20 and 28-36
Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject's health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Positive values indicate improvement
Time frame: From Study Baseline to Week 4, 16-20 and 28-36
Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject's health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Frequency -2/-1= improvement by two/one categories; 0 = no change; +1/+2 worsening by one/two categories.
Time frame: From Study Baseline to Week 12-16, 24-32 and 36-48
Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject's health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Positive values indicate improvement.
Time frame: From Study Baseline to Week 12-16, 24-32 and 36-48
The clinical study was conducted at 30 sites located in Canada, France, Germany, Italy, Norway, Portugal, Spain, and the United States of America.
| Milestone | IncobotulinumtoxinA (Xeomin) (up to 800 Units) |
|---|---|
| Started | 155 |
| Completed | 137 |
| Not completed | 18 |
| Withdrew: Adverse event | 5 |
| Withdrew: Withdrawal by subject | 5 |
| Withdrew: Lost to follow-up | 3 |
| Withdrew: Predefined discontinuation criteria | 3 |
| Withdrew: Non-compliance | 1 |
| Withdrew: Administrative reason | 1 |
The AS 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).
| units on a scale | IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 |
|---|---|---|---|---|---|---|
| Ashworth Scale (AS) Scores of the Target Joint Selected at Study Baseline Visit | 3.0 ± 0.7 | 2.1 ± 0.9 | 2.7 ± 0.7 | 2.0 ± 0.9 | 2.6 ± 0.8 | 1.7 ± 1.0 |
The AS 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).
| units on a scale | IncobotulinumtoxinA (Xeomin): Injection Cycle 1 | IncobotulinumtoxinA (Xeomin): Injection Cycle 2 | IncobotulinumtoxinA (Xeomin): Injection Cycle 3 |
|---|---|---|---|
| Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Injection Cycle Baseline Visits to Respective Control Visits | -0.8 ± 0.9 | -0.8 ± 0.8 | -0.9 ± 0.9 |
The AS 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).
| units on a scale | IncobotulinumtoxinA (Xeomin): Time Frame 1 | IncobotulinumtoxinA (Xeomin): Time Frame 2 | IncobotulinumtoxinA (Xeomin): Time Frame 3 |
|---|---|---|---|
| Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Study Baseline Visit to Control Visits of Injection Cycles | -0.8 ± 0.9 | -1.0 ± 0.9 | -1.3 ± 1.0 |
The AS 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).
| units on a scale | IncobotulinumtoxinA (Xeomin): Timeframe 1 | IncobotulinumtoxinA (Xeomin): Time Frame 2 | IncobotulinumtoxinA (Xeomin): Time Frame 3 |
|---|---|---|---|
| Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | -0.2 ± 0.7 | -0.3 ± 0.8 | -0.7 ± 0.9 |
Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS 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).
| units on a scale | IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 |
|---|---|---|---|---|---|---|
| Internally rotated/extended/adducted shoulder | 2.7 ± 0.6 | 2.2 ± 0.8 | 2.5 ± 0.8 | 2.0 ± 0.9 | 2.5 ± 0.8 | 1.9 ± 0.9 |
| Flexed elbow | 2.6 ± 0.7 | 1.9 ± 0.9 | 2.4 ± 0.7 | 1.7 ± 0.9 | 2.4 ± 0.8 | 1.4 ± 0.9 |
| Extended elbow | 2.7 ± 0.5 | 1.8 ± 0.9 | 2.5 ± 0.6 | 2.1 ± 0.7 | 2.6 ± 0.6 | 1.7 ± 0.8 |
| Pronated forearm | 2.7 ± 0.7 | 1.6 ± 0.9 | 2.4 ± 0.8 | 1.7 ± 1.0 | 2.5 ± 0.7 | 1.4 ± 0.8 |
| Flexed wrist | 2.7 ± 0.8 | 1.8 ± 1.0 | 2.4 ± 0.9 | 1.5 ± 1.0 | 2.4 ± 0.8 | 1.4 ± 1.0 |
| Clenched fist | 2.9 ± 0.7 | 2.0 ± 0.9 | 2.7 ± 0.8 | 1.8 ± 0.9 | 2.5 ± 0.7 | 1.5 ± 0.9 |
| Thumb in palm | 2.4 ± 0.9 | 1.5 ± 1.1 | 2.3 ± 0.9 | 1.4 ± 1.0 | 2.2 ± 0.8 | 1.3 ± 1.0 |
| Flexed hip | — | — | — | — | 1.8 ± 0.8 | 1.4 ± 0.9 |
| Adducted thigh | 1.8 ± 0.5 | 1.5 ± 0.6 | 2.0 ± 1.2 | 1.9 ± 0.9 | 2.3 ± 0.8 | 2.0 ± 0.6 |
| Internally rotated hip | 3.0 ± NA | 2.0 ± NA | 2.0 ± 1.4 | 2.0 ± 1.4 | 2.7 ± 0.6 | 1.7 ± 0.6 |
| Flexed knee | 2.4 ± 0.7 | 2.0 ± 0.7 | 2.4 ± 0.6 | 1.8 ± 0.7 | 2.5 ± 0.7 | 1.8 ± 1.0 |
| Extended knee | 2.6 ± 0.7 | 2.3 ± 0.9 | 2.1 ± 0.8 | 1.8 ± 0.9 | 2.2 ± 0.8 | 1.5 ± 0.8 |
| Pes equinovarus | 2.8 ± 0.7 | 2.1 ± 0.9 | 2.6 ± 0.8 | 1.9 ± 1.0 | 2.5 ± 0.8 | 1.6 ± 0.9 |
| Pes equinovalgus | 2.8 ± 0.4 | 2.4 ± 1.3 | 2.6 ± 0.8 | 1.9 ± 0.7 | 2.3 ± 0.9 | 2.0 ± 1.1 |
| Extended hallux | 1.7 ± 1.1 | 0.9 ± 0.7 | 1.8 ± 0.8 | 0.9 ± 0.7 | 1.9 ± 0.9 | 1.1 ± 0.8 |
| Flexed toes | 1.8 ± 0.9 | 1.3 ± 0.8 | 1.6 ± 0.9 | 1.1 ± 0.8 | 1.9 ± 0.9 | 1.1 ± 0.8 |
Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS 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).
| units on a scale | IncobotulinumtoxinA (Xeomin): Injection Cycle 1 | IncobotulinumtoxinA (Xeomin): Injection Cycle 2 | IncobotulinumtoxinA (Xeomin): Injection Cycle 3 |
|---|---|---|---|
| Internally rotated/extended/adducted shoulder | -0.5 ± 0.8 | -0.6 ± 0.8 | -0.5 ± 0.8 |
| Flexed elbow | -0.7 ± 0.8 | -0.7 ± 0.8 | -0.9 ± 0.9 |
| Extended elbow | -0.9 ± 0.8 | -0.5 ± 0.9 | -0.8 ± 0.8 |
| Pronated forearm | -1.1 ± 0.6 | -0.7 ± 0.7 | -1.0 ± 0.8 |
| Flexed wrist | -0.9 ± 0.8 | -0.9 ± 0.8 | -1.0 ± 0.9 |
| Clenched fist | -0.9 ± 0.8 | -0.9 ± 0.8 | -1.1 ± 0.8 |
| Thumb in palm | -0.9 ± 1.0 | -0.9 ± 1.1 | -0.9 ± 1.0 |
| Flexed hip | — | — | -0.4 ± 0.9 |
| Aducted thigh | -0.3 ± 0.5 | -0.1 ± 0.7 | -0.1 ± 1.0 |
| Internally rotated hip | -1.0 ± NA | 0.0 ± 0.0 | -1.0 ± 1.0 |
| Flexed knee | -0.4 ± 0.5 | -0.6 ± 0.6 | -0.8 ± 0.9 |
| Extended knee | -0.4 ± 0.5 | -0.4 ± 0.7 | -0.7 ± 0.9 |
| Pes equinovarus | -0.7 ± 0.8 | -0.7 ± 0.8 | -0.8 ± 0.8 |
| Pes equinovalgus | -0.4 ± 1.1 | -0.7 ± 0.7 | -0.3 ± 0.7 |
| Extended hallux | -0.8 ± 0.9 | -0.9 ± 1.0 | -0.8 ± 1.3 |
| Flexed toes | -0.5 ± 0.8 | -0.5 ± 0.8 | -0.8 ± 0.7 |
Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS 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).
| units on a scale | IncobotulinumtoxinA (Xeomin): Time Frame 1 | IncobotulinumtoxinA (Xeomin): Time Frame 2 | IncobotulinumtoxinA (Xeomin): Time Frame 3 |
|---|---|---|---|
| Internally rotated/extended/adducted shoulder | -0.5 ± 0.8 | -0.6 ± 0.9 | -0.5 ± 1.0 |
| Flexed elbow | -0.7 ± 0.8 | -0.9 ± 0.8 | -1.2 ± 0.9 |
| Extended elbow | -0.9 ± 0.8 | -0.7 ± 0.8 | -0.9 ± 1.0 |
| Pronated forearm | -1.1 ± 0.6 | -1.0 ± 0.9 | -1.1 ± 0.9 |
| Flexed wrist | -0.9 ± 0.8 | -1.1 ± 0.9 | -1.2 ± 1.1 |
| Clenched fist | -0.9 ± 0.8 | -1.1 ± 0.9 | -1.4 ± 0.9 |
| Thumb in palm | -0.9 ± 1.0 | -1.0 ± 1.2 | -1.1 ± 1.3 |
| Flexed hip | — | — | -0.6 ± 1.5 |
| Adducted thigh | -0.3 ± 0.5 | -0.1 ± 0.7 | -0.6 ± 0.8 |
| Internally rotated hip | -1.0 ± NA | -0.5 ± 0.7 | -0.7 ± 1.5 |
| Flexed knee | -0.4 ± 0.5 | -0.4 ± 0.8 | -0.4 ± 1.2 |
| Extended knee | -0.4 ± 0.5 | -0.4 ± 0.6 | -0.6 ± 0.6 |
| Pes equinovarus | -0.7 ± 0.8 | -0.8 ± 0.9 | -1.1 ± 0.9 |
| Pes equinovalgus | -0.4 ± 1.1 | -0.9 ± 0.6 | -0.4 ± 0.7 |
| Extended hallux | -0.8 ± 0.9 | -0.9 ± 1.1 | -0.2 ± 1.3 |
| Flexed toes | -0.5 ± 0.8 | -0.5 ± 0.7 | -0.6 ± 0.8 |
Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS 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).
| units on a scale | IncobotulinumtoxinA (Xeomin): Time Frame 1 | IncobotulinumtoxinA (Xeomin): Time Frame 2 | IncobotulinumtoxinA (Xeomin): Time Frame 3 |
|---|---|---|---|
| Internally rotated/extended/adducted shoulder | -0.0 ± 0.7 | 0.0 ± 0.9 | -0.3 ± 0.9 |
| Flexed elbow | -0.2 ± 0.7 | -0.3 ± 0.8 | -0.8 ± 0.9 |
| Extended elbow | -0.2 ± 0.7 | -0.1 ± 0.9 | -0.2 ± 0.8 |
| Pronated forearm | -0.3 ± 0.9 | -0.1 ± 0.7 | -0.7 ± 1.0 |
| Flexed wrist | -0.2 ± 0.7 | -0.2 ± 1.0 | -0.7 ± 1.0 |
| Clenched fist | -0.2 ± 0.7 | -0.3 ± 0.7 | -0.8 ± 0.9 |
| Thumb in palm | -0.2 ± 0.9 | -0.3 ± 0.9 | -0.8 ± 1.1 |
| Flexed hip | — | -0.2 ± 1.0 | -0.3 ± 1.4 |
| Adducted thigh | 0 ± 0 | -0.3 ± 0.5 | -0.4 ± 0.8 |
| Internally rotated hip | -0.5 ± 0.7 | 0.3 ± 0.6 | 0.0 ± 1.0 |
| Flexed knee | 0.1 ± 0.9 | 0.4 ± 1.2 | -0.4 ± 1.1 |
| Extended knee | -0.1 ± 0.4 | 0.1 ± 0.5 | -0.4 ± 0.7 |
| Pes equinovarus | -0.1 ± 0.6 | -0.2 ± 0.7 | -0.7 ± 0.9 |
| Pes equinovalgus | -0.2 ± 0.4 | -0.1 ± 0.6 | -0.4 ± 0.5 |
| Extended hallux | 0.0 ± 1.2 | 0.6 ± 1.3 | -0.2 ± 1.0 |
| Flexed toes | -0.0 ± 0.7 | 0.2 ± 0.7 | -0.4 ± 0.7 |
The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52.
| units on a scale | IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 |
|---|---|---|---|---|---|---|
| Resistance to Passive Movement Scale (REPAS) Scores of Treated Side | 24.8 ± 6.7 | 20.2 ± 7.1 | 24.0 ± 7.0 | 18.1 ± 7.6 | 22.9 ± 7.2 | 15.7 ± 7.6 |
The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52.
| units on a scale | IncobotulinumtoxinA (Xeomin): Injection Cycle 1 | IncobotulinumtoxinA (Xeomin): Injection Cycle 2 | IncobotulinumtoxinA (Xeomin): Injection Cycle 3 |
|---|---|---|---|
| Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Injection Cycle Baseline Visits to Respective Control Visits | -4.6 ± 3.9 | -5.9 ± 4.2 | -7.1 ± 4.8 |
The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52.
| units on a scale | IncobotulinumtoxinA (Xeomin): Time Frame 1 | IncobotulinumtoxinA (Xeomin): Time Frame 2 | IncobotulinumtoxinA (Xeomin): Time Frame 3 |
|---|---|---|---|
| Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Study Baseline Visit to Control Visits of Injection Cycles | -4.6 ± 3.9 | -6.7 ± 4.6 | -9.0 ± 5.5 |
The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52.
| units on a scale | IncobotulinumtoxinA (Xeomin): Time Frame1 | IncobotulinumtoxinA (Xeomin): Time Frame 2 | IncobotulinumtoxinA (Xeomin): Injection Cycle 3 |
|---|---|---|---|
| Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | -0.8 ± 4.2 | -1.9 ± 4.7 | -5.5 ± 5.3 |
The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent.
| units on a scale | IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 |
|---|---|---|---|---|---|---|
| Functional Ambulation Classification (FAC) Scale Scores | 3.5 ± 1.4 | 3.7 ± 1.3 | 3.7 ± 1.3 | 3.8 ± 1.3 | 3.8 ± 1.3 | 3.9 ± 1.2 |
The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent.
| units on a scale | IncobotulinumtoxinA (Xeomin): Injection Cycle 1 | IncobotulinumtoxinA (Xeomin): Injection Cycle 2 | IncobotulinumtoxinA (Xeomin): Injection Cycle 3 |
|---|---|---|---|
| Change of Functional Ambulation Classification (FAC) Score From Injection Cycle Baseline Visits to Respective Control Visits | 0.1 ± 0.5 | 0.1 ± 0.4 | 0.1 ± 0.4 |
The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent.
| units on a scale | IncobotulinumtoxinA (Xeomin): Time Frame 1 | IncobotulinumtoxinA (Xeomin): Time Frame 2 | IncobotulinumtoxinA (Xeomin): Time Frame 3 |
|---|---|---|---|
| Change of Functional Ambulation Classification (FAC) Score From Study Baseline Visit to Control Visits of Injection Cycles | 0.1 ± 0.5 | 0.3 ± 0.6 | 0.4 ± 0.7 |
The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent.
| units on a scale | IncobotulinumtoxinA (Xeomin): Time Frame 1 | IncobotulinumtoxinA (Xeomin): Time Frame 2 | IncobotulinumtoxinA (Xeomin): Time Frame 3 |
|---|---|---|---|
| Change of Functional Ambulation Classification (FAC) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | 0.2 ± 0.5 | 0.3 ± 0.6 | 0.4 ± 0.8 |
Change in goal attainment T-scores from respective injection cycle baseline visit. GAS measures the extent to which subject's individual goals are achieved in course of intervention. Subject and treating team have to identify 2 personal goals for each treated limb at each injection cycle. Investigator rates the GAS score for each injection cycle. Degree of goal attainment is rated on 5-point scale (-2, -1, 0, +1, +2; study baseline set to -1) and in order to account for interindividual differences in the number of goals, ratings are computed with the Kiresuk formula (Kiresuk \& Sherman, Community Mental Health Journal. 1968;4(6):443-53) resulting in T-scores measuring the degree of goal attainment at each visit. A score of 50 indicates that the individual has reached the expected level of achievement for all goals. The size of change from measurement to measurement indicates incremental change towards or away from goal attainment. Positive values indicate a higher goal attainment.
| units on a scale | IncobotulinumtoxinA (Xeomin): Injection Cycle 1 | IncobotulinumtoxinA (Xeomin): Injection Cycle 2 | IncobotulinumtoxinA (Xeomin): Injection Cycle 3 |
|---|---|---|---|
| Upper limb | 7.178 ± 9.254 | 10.601 ± 9.211 | 13.028 ± 8.765 |
| Lower limb | 8.222 ± 9.649 | 10.914 ± 9.251 | 13.579 ± 10.196 |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value.
| units on a scale | IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 |
|---|---|---|---|---|---|---|
| Disability Assessment Scale (DAS) Scores in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb | 2.6 ± 0.5 | 2.0 ± 0.7 | 2.4 ± 0.6 | 1.7 ± 0.7 | 2.2 ± 0.6 | 1.5 ± 0.7 |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value change.
| units on a scale | IncobotulinumtoxinA (Xeomin): Injection Cycle 1 | IncobotulinumtoxinA (Xeomin): Injection Cycle 2 | IncobotulinumtoxinA (Xeomin): Injection Cycle 3 |
|---|---|---|---|
| Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Injection Cycle Baseline Visits to Respective Control Visits | -0.6 ± 0.7 | -0.7 ± 0.7 | -0.7 ± 0.8 |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value change.
| units on a scale | IncobotulinumtoxinA (Xeomin): Time Frame 1 | IncobotulinumtoxinA (Xeomin): Time Frame 2 | IncobotulinumtoxinA (Xeomin): Time Frame 3 |
|---|---|---|---|
| Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Study Baseline Visit to Control Visits of Injection Cycles | -0.6 ± 0.7 | -0.9 ± 0.8 | -1.0 ± 0.9 |
Treatment-emergent Adverse Events (TEASs) are events observed from the time point of first injection until 16 weeks after last injection. Values reported here refer to the number of subjects affected.
| subjects | IncobotulinumtoxinA (Xeomin): Injection Cycle 1 | IncobotulinumtoxinA (Xeomin): Injection Cycle 2 | IncobotulinumtoxinA (Xeomin): Injection Cycle 3 |
|---|---|---|---|
| Any TEAE | 56 | 57 | 36 |
| Any related TEAE | 7 | 8 | 4 |
| Any TEAE of special interest | 6 | 8 | 7 |
| Any related TEAE of special interest | 2 | 4 | 3 |
| Any serious TEAE | 4 | 11 | 3 |
| Any related serious TEAE | 0 | 0 | 0 |
A 4-point Likert scale was used with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor.
| subjects | IncobotulinumtoxinA (Xeomin): Injection Cycle 1 | IncobotulinumtoxinA (Xeomin): Injection Cycle 2 | IncobotulinumtoxinA (Xeomin): Injection Cycle 3 |
|---|---|---|---|
| Very good | 121 | 111 | 117 |
| Good | 29 | 26 | 20 |
| Moderate | 3 | 3 | 1 |
| Poor | 0 | 2 | 0 |
| Missing | 2 | 10 | 2 |
The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value change.
| units on a scale | IncobotulinumtoxinA (Xeomin): Time Frame 1 | IncobotulinumtoxinA (Xeomin): Time Frame 2 | IncobotulinumtoxinA (Xeomin): Time Frame 3 |
|---|---|---|---|
| Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit. | -0.2 ± 0.6 | -0.3 ± 0.7 | -0.9 ± 0.9 |
Investigator assessment. The global assessment of efficacy will be assessed by the investigator, the subject, and the caregiver using a 4-point Likert scale with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor.
| subjects | IncobotulinumtoxinA (Xeomin): Injection Cycle 1 | IncobotulinumtoxinA (Xeomin): Injection Cycle 2 | IncobotulinumtoxinA (Xeomin): Injection Cycle 3 |
|---|---|---|---|
| Frequency 1 (very good) | 7 | 21 | 38 |
| Frequency 2 (good) | 79 | 89 | 87 |
| Frequency 3 (moderate) | 63 | 28 | 11 |
| Frequency 4 (poor) | 3 | 3 | 1 |
| Missing | 3 | 11 | 3 |
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject's health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems.
| subjects | IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 |
|---|---|---|---|---|---|---|
| Mobility: Frequency 1 | 12 | 27 | 14 | 24 | 19 | 20 |
| Mobility: Frequency 2 | 139 | 125 | 136 | 122 | 119 | 116 |
| Mobility: Frequency 3 | 4 | 3 | 2 | 3 | 2 | 2 |
| Self-care: Frequency 1 | 30 | 31 | 30 | 24 | 24 | 22 |
| Self-care: Frequency 2 | 96 | 100 | 101 | 104 | 101 | 107 |
| Self-care: Frequency 3 | 29 | 24 | 21 | 20 | 15 | 9 |
| Usual activities: Frequency 1 | 11 | 19 | 16 | 21 | 15 | 17 |
| Usual activities: Frequency 2 | 113 | 108 | 119 | 110 | 113 | 111 |
| Usual activities: Frequency 3 | 31 | 28 | 17 | 17 | 12 | 10 |
| Pain/discomfort: Frequency 1 | 53 | 73 | 56 | 74 | 57 | 77 |
| Pain/discomfort: Frequency 2 | 85 | 75 | 88 | 70 | 79 | 58 |
| Pain/discomfort: Frequency 3 | 17 | 7 | 8 | 5 | 4 | 3 |
| Anxiety/depression: Frequency 1 | 72 | 82 | 83 | 93 | 78 | 85 |
| Anxiety/depression: Frequency 2 | 69 | 67 | 63 | 49 | 57 | 49 |
| Anxiety/depression: Frequency 3 | 14 | 6 | 6 | 7 | 5 | 4 |
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values represent better outcome).
| units on a scale | IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit | IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1 | IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit | IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1 | IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit | IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1 |
|---|---|---|---|---|---|---|
| Visual Analogue Scale (VAS) of EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores | 59.9 ± 18.9 | 66.7 ± 17.6 | 67.2 ± 17.0 | 69.9 ± 16.6 | 67.1 ± 17.9 | 68.9 ± 17.7 |
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject's health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Frequency -2/-1= improvement by two/one categories; 0 = no change; +1/+2 worsening by one/two categories.
| Subjects | IncobotulinumtoxinA (Xeomin): Injection Cycle 1 | IncobotulinumtoxinA (Xeomin): Injection Cycle 2 | IncobotulinumtoxinA (Xeomin): Injection Cycle 3 |
|---|---|---|---|
| Mobility: Frequency -1 | 18 | 11 | 6 |
| Mobility: Frequency 0 | 135 | 136 | 128 |
| Mobility: Frequency 1 | 2 | 2 | 4 |
| Self-care: Frequency -1 | 19 | 7 | 11 |
| Self-care: Frequency 0 | 123 | 127 | 121 |
| Self-care: Frequency 1 | 13 | 14 | 6 |
| Usual activities: Frequency -2 | 0 | 0 | 1 |
| Usual activities: Frequency -1 | 20 | 18 | 7 |
| Usual activities: Frequency 0 | 126 | 116 | 126 |
| Usual activities: Frequency 1 | 9 | 14 | 4 |
| Pain/discomfort: Frequency -2 | 1 | 2 | 0 |
| Pain/discomfort: Frequency -1 | 39 | 30 | 29 |
| Pain/discomfort: Frequency 0 | 105 | 105 | 102 |
| Pain/discomfort: Frequency 1 | 9 | 12 | 7 |
| Pain/discomfort: Frequency 2 | 1 | 0 | 0 |
| Anxiety/depression:Frequency -2 | 0 | 0 | 1 |
| Anxiety/depression:Frequency -1 | 27 | 18 | 17 |
| Anxiety/depression: Frequency 0 | 119 | 121 | 111 |
| Anxiety/depression: Frequency 1 | 9 | 9 | 9 |
| Anxiety/depression: Frequency 2 | 0 | 1 | 0 |
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values represent better outcome).
| units on a scale | IncobotulinumtoxinA (Xeomin): Injection Cycle 1 | IncobotulinumtoxinA (Xeomin): Injection Cycle 2 | IncobotulinumtoxinA (Xeomin): Injection Cycle 3 |
|---|---|---|---|
| Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits | 6.7 ± 14.1 | 2.4 ± 12.4 | 1.7 ± 12.4 |
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject's health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Frequency -2/-1= improvement by two/one categories; 0 = no change; +1/+2 worsening by one/two categories.
| subjects | IncobotulinumtoxinA (Xeomin): Time Frame 1 | IncobotulinumtoxinA (Xeomin): Time Frame 2 | IncobotulinumtoxinA (Xeomin): Time Frame 3 |
|---|---|---|---|
| Mobility: Frequency -1 | 18 | 16 | 14 |
| Mobility: Frequency 0 | 135 | 127 | 118 |
| Mobility: Frequency 1 | 2 | 5 | 5 |
| Self-care: Frequency -1 | 19 | 20 | 25 |
| Self-care: Frequency 0 | 123 | 110 | 100 |
| Self-care: Frequency 1 | 13 | 18 | 13 |
| Usual activities: Frequency -2 | 0 | 1 | 1 |
| Usual activities: Frequency -1 | 20 | 31 | 31 |
| Usual activities: Frequency 0 | 126 | 103 | 98 |
| Usual activities: Frequency 1 | 9 | 13 | 8 |
| Pain/discomfort: Frequency -2 | 1 | 3 | 3 |
| Pain/discomfort: Frequency -1 | 39 | 40 | 42 |
| Pain/discomfort: Frequency 0 | 105 | 93 | 85 |
| Pain/discomfort: Frequency 1 | 9 | 13 | 8 |
| Pain/discomfort: Frequency 2 | 1 | 0 | 0 |
| Anxiety/depression:Frequency -2 | 0 | 7 | 6 |
| Anxiety/depression:Frequency -1 | 27 | 28 | 32 |
| Anxiety/depression:Frequency 0 | 119 | 100 | 85 |
| Anxiety/depression:Frequency 1 | 9 | 14 | 15 |
| Anxiety/depression:Frequency 2 | 0 | 0 | 0 |
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject's health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Positive values indicate improvement
| units on a scale | IncobotulinumtoxinA (Xeomin): Injection Cycle 1 | IncobotulinumtoxinA (Xeomin): Injection Cycle 2 | IncobotulinumtoxinA (Xeomin): Injection Cycle 3 |
|---|---|---|---|
| Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles | 6.7 ± 14.1 | 9.6 ± 16.3 | 8.6 ± 17.0 |
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject's health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Frequency -2/-1= improvement by two/one categories; 0 = no change; +1/+2 worsening by one/two categories.
| subjects | IncobotulinumtoxinA (Xeomin): Time Frame 1 | IncobotulinumtoxinA (Xeomin): Time Frame 2 | IncobotulinumtoxinA (Xeomin): Time Frame 3 |
|---|---|---|---|
| Mobility: Frequency -1 | 10 | 13 | 16 |
| Mobility: Frequency 0 | 137 | 121 | 116 |
| Mobility: Frequency 1 | 5 | 5 | 4 |
| Self-care: Frequency -1 | 20 | 24 | 30 |
| Self-care: Frequency 0 | 120 | 99 | 97 |
| Self-care: Frequency 1 | 12 | 17 | 10 |
| Usual activities: Frequency -2 | 1 | 1 | 1 |
| Usual activities: Frequency -1 | 21 | 26 | 33 |
| Usual activities: Frequency 0 | 125 | 106 | 96 |
| Usual activities: Frequency 1 | 5 | 7 | 7 |
| Pain/discomfort: Frequency -2 | 0 | 0 | 3 |
| Pain/discomfort: Frequency -1 | 32 | 35 | 40 |
| Pain/discomfort: Frequency 0 | 100 | 89 | 81 |
| Pain/discomfort: Frequency 1 | 20 | 15 | 13 |
| Pain/discomfort: Frequency 2 | 0 | 1 | 0 |
| Anxiety/depression: Frequency -2 | 2 | 4 | 5 |
| Anxiety/depression: Frequency -1 | 29 | 28 | 30 |
| Anxiety/depression: Frequency 0 | 108 | 91 | 89 |
| Anxiety/depression: Frequency 1 | 12 | 17 | 13 |
| Anxiety/depression: Frequency 2 | 1 | 0 | 0 |
The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject's health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Positive values indicate improvement.
| units on a scale | IncobotulinumtoxinA (Xeomin): Time Frame 1 | IncobotulinumtoxinA (Xeomin): Time Frame 2 | IncobotulinumtoxinA (Xeomin): Time Frame 3 |
|---|---|---|---|
| Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit | 7.1 ± 16.3 | 6.9 ± 15.8 | 10.5 ± 17.5 |
Collected over From the time point of first injection until 16 weeks after last injection. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IncobotulinumtoxinA (Xeomin) (up to 800 Units) | — | 17/155 (11%) | 34/155 (21.9%) |
| Event | IncobotulinumtoxinA (Xeomin) (up to 800 Units) |
|---|---|
| ConvulsionNervous system disorders | 4/155 |
| EpilepsyNervous system disorders | 3/155 |
| Cerebral infarctionNervous system disorders | 2/155 |
| PneumoniaInfections and infestations | 2/155 |
| Ischemic strokeNervous system disorders | 1/155 |
| BronchopneumoniaInfections and infestations | 1/155 |
| Meningitis bacterialInfections and infestations | 1/155 |
| SepsisInfections and infestations | 1/155 |
| SinusitisInfections and infestations | 1/155 |
| Cardiac failureCardiac disorders | 1/155 |
| Event | IncobotulinumtoxinA (Xeomin) (up to 800 Units) |
|---|---|
| FallInjury, poisoning and procedural complications | 12/155 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 10/155 |
| DiarrhoeaGastrointestinal disorders | 10/155 |
| NasopharyngitisInfections and infestations | 10/155 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 8/155 |
The safety evaluation set (SES) is the subset of all subjects who were exposed to study medication at least once.
| Age, Continuous(years) | IncobotulinumtoxinA (Xeomin) (up to 800 Units) |
|---|---|
| Mean | 53.7 ± 13.1 |
| Sex: Female, Male(Participants) | IncobotulinumtoxinA (Xeomin) (up to 800 Units) |
|---|---|
| Female | 51 |
| Male | 104 |
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