Trials / Completed
CompletedNCT01249417
Dysport® Pediatric Lower Limb Spasticity Study
A Phase III, Multicentre, Double Blind, Prospective, Randomised, Placebo Controlled Study Assessing the Efficacy and Safety of 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
- 241 (actual)
- Sponsor
- Ipsen · Industry
- Sex
- All
- Age
- 2 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this research study is to determine whether Dysport® is effective in the treatment of increased stiffness of the calf muscles and to evaluate the safety of this treatment in children with Cerebral Palsy. In addition this study will also check whether Dysport® can lessen the pain caused by spasticity and improve the child's wellbeing.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Botulinum toxin type A | I.M. (in the muscle) injection on day 1 of a single treatment cycle. |
| DRUG | Placebo | I.M. injection on day 1 of a single treatment cycle. |
Timeline
- Start date
- 2011-07-01
- Primary completion
- 2014-02-01
- Completion
- 2014-06-01
- First posted
- 2010-11-29
- Last updated
- 2022-09-28
- Results posted
- 2017-02-03
Locations
29 sites across 6 countries: United States, Chile, France, Mexico, Poland, Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT01249417. Inclusion in this directory is not an endorsement.