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NCT05134649 · ClinicalTrials.gov registry record · Phase 3
A Study To Assess the Safety of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 292
- Enrollment target
NCT05134649: Completed Phase 3 study, sponsored by AbbVie.
NCT05134649 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 292 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05134649, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 292 participants
- Enrollment target
Study Summary
This is a Phase 3, open-label extension study to evaluate the long-term safety of repeat BOTOX treatments in adult participants with Platysma Prominence. Participants who completed the lead-in Phase 3 Study M21-309 and met eligibility requirements could enroll in this open-label extension study. Planned study enrollment was approximately 270 participants. Participants who met treatment criteria could receive up to 3 administrations of BOTOX. Day 1 (study entry) was the same day as Day 120/study exit visit of the lead-in Phase 3 study. The first administration of study drug could occur at the Day 1 visit, and the last administration of study drug could occur at the Day 180 visit (60 days prior to Day 240/study exit). Once a subject was enrolled in this study, monthly follow-up visits occurred.
Primary Outcome
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a casual relationship with this treatment.
Interventions
- DRUG OnabotulinumtoxinA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 292 participants |
| Start Date | 2021-11-16 |
| Est. Completion | 2023-08-18 |
| Phase | Phase 3 |
What the finished NCT05134649 record still lists
NCT05134649 is an interventional study that assigns participants to a tested intervention. The registered 292 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 (62% lower).
The record links to 0 conditions, and to 1 intervention - of which OnabotulinumtoxinA is the first listed.
NCT05134649 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05134649 about?
NCT05134649 is a clinical study titled "A Study To Assess the Safety of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence". This is a Phase 3, open-label extension study to evaluate the long-term safety of repeat BOTOX treatments in adult participants with Platysma Prominence. Participants who completed the lead-in Phase 3 Study M21-309 and met eligibility requirements could enroll in this open-label extension study. Pl...
What is the current status of trial NCT05134649?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 292 participants. The study started on 2021-11-16. Estimated completion is 2023-08-18.
What interventions are being tested in trial NCT05134649?
The interventions under investigation include: OnabotulinumtoxinA (DRUG).
Who is sponsoring clinical trial NCT05134649?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05134649's enrollment target sits among peer trials
292 1166th of 2000 higher than 833 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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