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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 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 292 participants.
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.
Interventions
- DRUG OnabotulinumtoxinA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 292 participants |
| Start Date | 2021-11-16 |
| Est. Completion | 2023-08-18 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05134649
The ClinicalTrials.gov registry entry for NCT05134649 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 292 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which OnabotulinumtoxinA is the first listed.
NCT05134649 reports 0 study locations.
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.
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