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NCT01313299 · ClinicalTrials.gov registry record · Phase 3
Dysport® Adult Upper Limb Spasticity
A Phase 3 study, sponsored by Ipsen.
- Completed
- Registry status
- Phase 3
- Development phase
- 243
- Enrollment target
NCT01313299: Completed Phase 3 study, sponsored by Ipsen.
NCT01313299 is a Phase 3 study that has completed, run by Ipsen. The registered enrollment target is 243 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
NCT01313299, a Phase 3 study, has completed, sponsored by Ipsen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 243 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 upper limb spasticity due to stroke or traumatic brain injury.
Primary Outcome
MAS scale is used to assess muscle tone using a 6-point scale where: 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) when the part is flexed or extended, 1±Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the ROM, 2=Marked increase in muscle tone through most of the ROM but affected part easily moved, 3=Considerable incre
Interventions
- DRUG Placebo
- BIOLOGICAL Botulinum toxin type A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 243 participants |
| Start Date | 2011-08 |
| Est. Completion | 2013-09 |
| Phase | Phase 3 |
What the finished NCT01313299 record still lists
NCT01313299 is an interventional study that assigns participants to a tested intervention. The registered 243 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.
NCT01313299 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01313299 about?
NCT01313299 is a clinical study titled "Dysport® Adult Upper Limb Spasticity". The purpose of this research study is to assess the efficacy of Dysport compared to placebo in improving muscle tone in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury.
What is the current status of trial NCT01313299?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 243 participants. The study started on 2011-08. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01313299?
The interventions under investigation include: Placebo (DRUG), Botulinum toxin type A (BIOLOGICAL).
Who is sponsoring clinical trial NCT01313299?
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 NCT01313299's enrollment target sits among peer trials
243 1269th of 2000 higher than 731 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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