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NCT01249417 · ClinicalTrials.gov registry record · Phase 3
Dysport® Pediatric Lower Limb Spasticity Study
A Phase 3 study, sponsored by Ipsen.
- Completed
- Registry status
- Phase 3
- Development phase
- 241
- Enrollment target
NCT01249417: Completed Phase 3 study, sponsored by Ipsen.
NCT01249417 is a Phase 3 study that has completed, run by Ipsen. The registered enrollment target is 241 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01249417, a Phase 3 study, has completed, sponsored by Ipsen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 241 participants
- Enrollment target
Study 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.
Primary Outcome
The MAS is a 6-point scale which measures the intensity of muscle tone by measuring the resistance of the muscle to passive lengthening or stretching. Investigator will grade muscle tone in the GSC from 0 (no increase in tone) to 4 (affected parts rigid in flexion or extension).
Interventions
- DRUG Placebo
- BIOLOGICAL Botulinum toxin type A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 241 participants |
| Start Date | 2011-07 |
| Est. Completion | 2014-06 |
| Phase | Phase 3 |
What the finished NCT01249417 record still lists
NCT01249417 is an interventional study that assigns participants to a tested intervention. The registered 241 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01249417 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01249417 about?
NCT01249417 is a clinical study titled "Dysport® Pediatric Lower Limb Spasticity Study". 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 cause...
What is the current status of trial NCT01249417?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 241 participants. The study started on 2011-07. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01249417?
The interventions under investigation include: Placebo (DRUG), Botulinum toxin type A (BIOLOGICAL).
Who is sponsoring clinical trial NCT01249417?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01249417's enrollment target sits among peer trials
241 1272nd of 2000 higher than 728 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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