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NCT01575054 · ClinicalTrials.gov registry record · Phase 3
BOTOX® Treatment in Adult Patients With Post-Stroke Lower Limb Spasticity
A Phase 3 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 3
- Development phase
- 468
- Enrollment target
NCT01575054: Completed Phase 3 study, sponsored by Allergan.
NCT01575054 is a Phase 3 study that has completed, run by Allergan. The registered enrollment target is 468 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01575054, a Phase 3 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 468 participants
- Enrollment target
Study Summary
This study will evaluate the safety and efficacy of BOTOX® in the treatment of adult post-stroke lower limb spasticity.
Primary Outcome
The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the ankle flexors by passively moving the ankle plantar flexor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. The average of the weeks 4 and 6 MAS-B ankle change from baseline is the primary end point. A negative number change from baseline indicates an im
Interventions
- DRUG Normal Saline
- BIOLOGICAL botulinum toxin Type A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 468 participants |
| Start Date | 2012-05 |
| Est. Completion | 2015-07 |
| Phase | Phase 3 |
What the finished NCT01575054 record still lists
NCT01575054 is an interventional study that assigns participants to a tested intervention. The registered 468 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 (39% lower).
The record links to 0 conditions, and to 2 interventions - of which Normal Saline is the first listed.
NCT01575054 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01575054 about?
NCT01575054 is a clinical study titled "BOTOX® Treatment in Adult Patients With Post-Stroke Lower Limb Spasticity". This study will evaluate the safety and efficacy of BOTOX® in the treatment of adult post-stroke lower limb spasticity.
What is the current status of trial NCT01575054?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 468 participants. The study started on 2012-05. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01575054?
The interventions under investigation include: Normal Saline (DRUG), botulinum toxin Type A (BIOLOGICAL).
Who is sponsoring clinical trial NCT01575054?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01575054's enrollment target sits among peer trials
468 816th of 2000 higher than 1,185 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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