Trials / Completed
CompletedNCT02188277
Treatment With Xeomin Versus Botox in Children With Spastic Equine and Equinovarus Foot Deformation in Pediatric Cerebral Palsy
Multi-center Open Comparative Randomized Trial of Clinical and Neurophysiological Efficacy and Safety of Xeomin (Botulinum Toxin Type A) vs. Botox (Complex of Botulinum Toxin Type A and Hemagglutinin) in Children With Spastic Equine and Equinovarus Foot Deformation in Pediatric Cerebral Palsy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 64 (actual)
- Sponsor
- Merz Pharmaceuticals GmbH · Industry
- Sex
- All
- Age
- 2 Years – 12 Years
- Healthy volunteers
- Not accepted
Summary
1. To assess the clinical and neurophysiological efficacy of Xeomin® vs. Botox® in children with spastic equine and equinovarus foot deformation in pediatric cerebral palsy 2. To assess the safety of Xeomin® use as compared to Botox® in this patient population
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Xeomin | 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. |
| DRUG | Botox® | Administration route is intramuscular injection into medial (two points) and lateral heads (two points) of gastrocnemius. |
Timeline
- Start date
- 2014-07-01
- Primary completion
- 2016-12-01
- Completion
- 2016-12-01
- First posted
- 2014-07-11
- Last updated
- 2017-01-26
Locations
3 sites across 1 country: Russia
Source: ClinicalTrials.gov record NCT02188277. Inclusion in this directory is not an endorsement.