18 and older, any sex, with Platysma Prominence. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Adverse EventsPrimary· 371 days (from enrollment in the lead-in study M21-309 through end of study M21-323)
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.
Group
Value
95% CI
Placebo (Lead-in)
33
BOTOX (Cycle 1)
74
BOTOX (Cycle 2)
46
BOTOX (Cycle 3)
26
BOTOX (Cycle 4)
11
BOTOX (All Treatment Cycles)
111
Total
127
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality and adverse event tables include events reported from enrollment in M21-323 to the end of study. The median time participants were followed was 239.0 days..
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 5 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05134649.