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NCT01251380 · ClinicalTrials.gov registry record · Phase 3
Dysport® Pediatric Lower Limb Spasticity Follow-on Study
A Phase 3 study, sponsored by Ipsen.
- Completed
- Registry status
- Phase 3
- Development phase
- 216
- Enrollment target
NCT01251380: Completed Phase 3 study, sponsored by Ipsen.
NCT01251380 is a Phase 3 study that has completed, run by Ipsen. The registered enrollment target is 216 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01251380, a Phase 3 study, has completed, sponsored by Ipsen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 216 participants
- Enrollment target
Study 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.
Primary Outcome
Adverse events (AEs) were monitored from the time of informed consent to the end of the study. All AEs were elicited by direct, non-leading questioning or by spontaneous reports.
Interventions
- BIOLOGICAL Botulinum toxin type A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 2011-10 |
| Est. Completion | 2015-01 |
| Phase | Phase 3 |
What the finished NCT01251380 record still lists
NCT01251380 is an interventional study that assigns participants to a tested intervention. The registered 216 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 (72% lower).
The record links to 0 conditions, and to 1 intervention - of which Botulinum toxin type A is the first listed.
NCT01251380 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01251380 about?
NCT01251380 is a clinical study titled "Dysport® Pediatric Lower Limb Spasticity Follow-on Study". 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.
What is the current status of trial NCT01251380?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 216 participants. The study started on 2011-10. Estimated completion is 2015-01.
What interventions are being tested in trial NCT01251380?
The interventions under investigation include: Botulinum toxin type A (BIOLOGICAL).
Who is sponsoring clinical trial NCT01251380?
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 NCT01251380's enrollment target sits among peer trials
216 1332nd of 2000 higher than 667 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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