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NCT04936542 · ClinicalTrials.gov registry record · Phase 4
A Study to Compare the Safety and Efficacy of Dysport® and Botox® in Adults With Upper Limb Spasticity.
A Phase 4 study, sponsored by Ipsen.
- Completed
- Registry status
- Phase 4
- Development phase
- 464
- Enrollment target
NCT04936542: Completed Phase 4 study, sponsored by Ipsen.
NCT04936542 is a Phase 4 study that has completed, run by Ipsen. The registered enrollment target is 464 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04936542, a Phase 4 study, has completed, sponsored by Ipsen.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 464 participants
- Enrollment target
Study Summary
This study is aiming to demonstrate the non-inferiority of AbobotulinumtoxinA (aboBoNT-A) versus OnabotulinumtoxinA (onaBoNT-A) as the primary safety endpoint, and the superiority of aboBoNT-A over onaBoNT-A with respect to duration of response as the key secondary efficacy endpoint when used at optimal doses according to approved prescribing information of each product.
Primary Outcome
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A TEAE was defined for each treatment cycle as any AE that occurred during the cycle if it was not present prior to treatment injection, or it was present prior to treatment injection but the intensity increased during the cycle. Percentage of participants with TEAEs that occurred during each cycle from injecti
Interventions
- BIOLOGICAL AboBoNT-A
- BIOLOGICAL OnaBoNT-A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 464 participants |
| Start Date | 2021-06-23 |
| Est. Completion | 2025-08-26 |
| Phase | Phase 4 |
What the finished NCT04936542 record still lists
NCT04936542 is an interventional study that assigns participants to a tested intervention. The registered 464 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 2 interventions - of which AboBoNT-A is the first listed.
NCT04936542 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04936542 about?
NCT04936542 is a clinical study titled "A Study to Compare the Safety and Efficacy of Dysport® and Botox® in Adults With Upper Limb Spasticity.". This study is aiming to demonstrate the non-inferiority of AbobotulinumtoxinA (aboBoNT-A) versus OnabotulinumtoxinA (onaBoNT-A) as the primary safety endpoint, and the superiority of aboBoNT-A over onaBoNT-A with respect to duration of response as the key secondary efficacy endpoint when used at opt...
What is the current status of trial NCT04936542?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 464 participants. The study started on 2021-06-23. Estimated completion is 2025-08-26.
What interventions are being tested in trial NCT04936542?
The interventions under investigation include: AboBoNT-A (BIOLOGICAL), OnaBoNT-A (BIOLOGICAL).
Who is sponsoring clinical trial NCT04936542?
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 NCT04936542's enrollment target sits among peer trials
464 183rd of 2000 higher than 1,818 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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