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NCT01249404 · ClinicalTrials.gov registry record · Phase 3
Dysport® Adult Lower Limb Spasticity Study
A Phase 3 study, sponsored by Ipsen.
- Completed
- Registry status
- Phase 3
- Development phase
- 388
- Enrollment target
NCT01249404: Completed Phase 3 study, sponsored by Ipsen.
NCT01249404 is a Phase 3 study that has completed, run by Ipsen. The registered enrollment target is 388 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01249404, a Phase 3 study, has completed, sponsored by Ipsen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 388 participants
- Enrollment target
Study Summary
The purpose of this research study is to assess the efficacy of Dysport® compared to placebo in improving muscle tone in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury.
Primary Outcome
Muscle tone in the treated limb was assessed by MAS in the GSC (with the knee extended) at baseline, at Weeks 1, 4 and 12, at discretionary visits at Weeks 16, 20 and 24, and at end of study. The MAS consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM)), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remai
Interventions
- DRUG Placebo
- BIOLOGICAL Botulinum toxin type A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 388 participants |
| Start Date | 2011-03 |
| Est. Completion | 2014-05 |
| Phase | Phase 3 |
What the finished NCT01249404 record still lists
NCT01249404 is an interventional study that assigns participants to a tested intervention. The registered 388 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 (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01249404 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01249404 about?
NCT01249404 is a clinical study titled "Dysport® Adult Lower Limb Spasticity Study". The purpose of this research study is to assess the efficacy of Dysport® compared to placebo in improving muscle tone in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury.
What is the current status of trial NCT01249404?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 388 participants. The study started on 2011-03. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01249404?
The interventions under investigation include: Placebo (DRUG), Botulinum toxin type A (BIOLOGICAL).
Who is sponsoring clinical trial NCT01249404?
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 NCT01249404's enrollment target sits among peer trials
388 973rd of 2000 higher than 1,028 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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