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NCT01251367 · ClinicalTrials.gov registry record · Phase 3
Dysport® Adult Lower Limb Spasticity Follow-on Study
A Phase 3 study, sponsored by Ipsen.
- Completed
- Registry status
- Phase 3
- Development phase
- 352
- Enrollment target
NCT01251367: Completed Phase 3 study, sponsored by Ipsen.
NCT01251367 is a Phase 3 study that has completed, run by Ipsen. The registered enrollment target is 352 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01251367, a Phase 3 study, has completed, sponsored by Ipsen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 352 participants
- Enrollment target
Study Summary
The purpose of this research study is to assess the long term safety of Dysport® in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.
Primary Outcome
Adverse events (AEs) were monitored from the time that the subject gave informed consent to the end of the study/early withdrawal (EOS/EW). An AE was reported as a TEAE if it was not present prior to study treatment administration in Study 140, or if it was present prior to study treatment in Study 140 but the intensity increased during the treatment phase of this study. Adverse events of special interest (AESIs) were identified as those assessed as being due to remote spread of effect of Dyspor
Interventions
- BIOLOGICAL Botulinum toxin type A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 352 participants |
| Start Date | 2011-06 |
| Est. Completion | 2015-04 |
| Phase | Phase 3 |
What the finished NCT01251367 record still lists
NCT01251367 is an interventional study that assigns participants to a tested intervention. The registered 352 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 (54% lower).
The record links to 0 conditions, and to 1 intervention - of which Botulinum toxin type A is the first listed.
NCT01251367 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01251367 about?
NCT01251367 is a clinical study titled "Dysport® Adult Lower Limb Spasticity Follow-on Study". The purpose of this research study is to assess the long term safety of Dysport® in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.
What is the current status of trial NCT01251367?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 352 participants. The study started on 2011-06. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01251367?
The interventions under investigation include: Botulinum toxin type A (BIOLOGICAL).
Who is sponsoring clinical trial NCT01251367?
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 NCT01251367's enrollment target sits among peer trials
352 1030th of 2000 higher than 968 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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