Trials / Completed
CompletedNCT01251380
Dysport® Pediatric Lower Limb Spasticity Follow-on Study
A Phase III, Prospective, Multicentre, Open Label, Extension Study Assessing the Long Term Safety and Efficacy of Repeated Treatment With DYSPORT® Used in the Treatment of Lower Limb Spasticity in Children With Dynamic Equinus Foot Deformity Due to Cerebral Palsy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 216 (actual)
- Sponsor
- Ipsen · Industry
- Sex
- All
- Age
- 2 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this research study was to determine the long term safety and efficacy of repeated treatments with Dysport® used in the treatment of lower limb spasticity in children with dynamic equinus foot deformity due to cerebral palsy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Botulinum toxin type A | Intramuscular (IM) injection on day 1 of each treatment cycle. |
Timeline
- Start date
- 2011-10-01
- Primary completion
- 2015-01-01
- Completion
- 2015-01-01
- First posted
- 2010-12-01
- Last updated
- 2022-09-28
- Results posted
- 2017-06-01
Locations
27 sites across 6 countries: United States, Chile, France, Mexico, Poland, Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT01251380. Inclusion in this directory is not an endorsement.