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NCT01313312 · ClinicalTrials.gov registry record · Phase 3
Dysport® Adult Upper Limb Spasticity Extension Study
A Phase 3 study, sponsored by Ipsen.
- Completed
- Registry status
- Phase 3
- Development phase
- 258
- Enrollment target
NCT01313312: Completed Phase 3 study, sponsored by Ipsen.
NCT01313312 is a Phase 3 study that has completed, run by Ipsen. The registered enrollment target is 258 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01313312, a Phase 3 study, has completed, sponsored by Ipsen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 258 participants
- Enrollment target
Study Summary
The purpose of this research study is to assess the long term safety of Dysport® in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.
Primary Outcome
A TEAE was reported as emergent if it arose (i.e. started or worsened in severity) in the treatment phase after the subject received study medication. Adverse events of special interest (AESIs) were identified as those assessed as being due to remote spread of effect of Dysport®, or any adverse event (AE) that was assessed as a hypersensitivity reaction. TEAEs, AESIs, severe TEAEs, serious adverse events (SAEs), treatment related TEAEs, TEAEs leading to withdrawal and fatal SAEs are summarised b
Interventions
- BIOLOGICAL Botulinum toxin type A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 258 participants |
| Start Date | 2011-11 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
What the finished NCT01313312 record still lists
NCT01313312 is an interventional study that assigns participants to a tested intervention. The registered 258 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 (67% lower).
The record links to 0 conditions, and to 1 intervention - of which Botulinum toxin type A is the first listed.
NCT01313312 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01313312 about?
NCT01313312 is a clinical study titled "Dysport® Adult Upper Limb Spasticity Extension Study". The purpose of this research study is to assess the long term safety of Dysport® in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.
What is the current status of trial NCT01313312?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 258 participants. The study started on 2011-11. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01313312?
The interventions under investigation include: Botulinum toxin type A (BIOLOGICAL).
Who is sponsoring clinical trial NCT01313312?
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 NCT01313312's enrollment target sits among peer trials
258 1235th of 2000 higher than 763 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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