A Phase 2 interventional study of Xeomin and Botox® in Cerebral Palsy, Spastic Paraplegia and Hemiparesis and Equine and Equinovarus Foot Deformation, sponsored by Merz Pharmaceuticals GmbH. Completed at 3 sites in Russian Federation. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2017-01-26.
Sponsored by Merz Pharmaceuticals GmbH (part of Merz Pharma) · Phase 2, Interventional, and Treatment
Among 32 studies testing botulinum toxin type A in Cerebral Palsy — 1 open to participants now, 1 under way, none of them phase 3. botulinum toxin type A · Cerebral Palsy.
Among the 32 studies testing botulinum toxin type A in Cerebral Palsy, this one is the 16th largest by enrollment, is one of 3 that started in 2014, is one of 5 in phase 2, and was the 20th registered.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
This study's enrollment of 64 is above the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →1 of the 32 studies testing botulinum toxin type A in Cerebral Palsy is open now.
botulinum toxin type A: first FDA approval 1991 (BOTOX COSMETIC), first EMA approval 2019. What it is approved for, and how studies give it, is on its page →
Of the 270 Cerebral Palsy studies recruiting now, 27 (10%) set no upper age limit and 235 (87%) stop at 75 or younger; 255 take children under 18; 51 take healthy volunteers.
This study: 2 Years to 12 Years · all sexes · no healthy volunteers.
The full table on the hub →32 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 3 started in 2014.
Median enrollment 63 across the 32 interventional studies. Of the 27 that completed or were terminated, 12 (44%) have results posted.
13 of 32 have an industry lead sponsor. The 10 most frequent:
Merz Pharmaceuticals GmbH is the lead sponsor of 61 studies on the registry; none are open to participants now.
Merz Pharmaceuticals GmbH has 5 studies filed under Cerebral Palsy — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 32 studies testing botulinum toxin type A in Cerebral Palsy, from their registry updates:
Nothing recorded among them since 2026-09-25.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
4-8 Units per kg body weight. Single injection cycle.
Drug: Xeomin
4-6(8) Units per kg body weight. Single injection cycle.
Drug: Botox®
Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Administration route is intramuscular injection into medial (two points) and lateral heads (two points) of gastrocnemius.
Also known as: IncobotulinumtoxinA, NT 201, Botulinum toxin type A (150 kiloDalton), free from complexing proteins
Administration route is intramuscular injection into medial (two points) and lateral heads (two points) of gastrocnemius.
Also known as: OnabotulinumtoxinA
Changes from baseline in the degree of spasticity in gastrocnemius according to modified Ashworth scale (AS)
The AS is a well known and commonly used scale in clinical trials with spasticity. In spastic muscles the resistance to passive movement is assessed. 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 baseline to day 30
Changes from baseline in patient percentage in groups by the degree of gastrocnemius spasticity according to modified Ashworth scale
Time frame: From baseline up to day 90
Percentage of decrease in M-response magnitude and area recorded from the lateral and medial gastrocnemius heads, from baseline values
Electromyography: The amplitude of a compound muscle action potential (M-wave) is recorded. An electrical stimulation is considered supramaximal when the M-wave amplitude no longer increases while increasing the stimulus. The measurements include the M-wave amplitude and the negative peak area of the M-wave.
Time frame: From baseline up to day 90
Changes from baseline in the ratio of M-response recorded from the lateral and medial gastrocnemius heads and from tibialis anterior
Time frame: From baseline up to day 90
Changes from baseline in angles and angle ratio of ankle joints at passive and voluntary extension
Time frame: From baseline up to day 90
Changes from baseline in motor activity according to Gross Motor Function Classification Systems (GMFCS) criteria
GMFCS is a 5-level classification system that is a standardized observational instrument for children with CP developed to measure change in gross motor function over time.
Time frame: From baseline up to day 90
Changes from baseline in the degree of spasticity in gastrocnemius according to modified Ashworth scale
Time frame: Baseline up to day 90
The record gives a start of Jul 2014, a primary completion of Dec 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum toxin type A