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Neurotoxin
A Study To Assess the Safety of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence
Phase 3
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 371 days (from enrollment in the lead-in study m21-309 through end of study m21-323)
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing whether Botox is safe for adults with a certain kind of neck muscle issue.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 371 days (from enrollment in the lead-in study m21-309 through end of study m21-323)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~371 days (from enrollment in the lead-in study m21-309 through end of study m21-323)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Adverse Events
Side effects data
From 2014 Phase 4 trial • 250 Patients • NCT020960816%
Headache
2%
Facial Asymmetry
1%
Human ehrlichiosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
IncobotulinumtoxinA
OnabotulinumtoxinA
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: BOTOXExperimental Treatment1 Intervention
BOTOX (OnabotulinumtoxinA) will be injected into the platysma muscle for up to 3 Cycles during study M21-323
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OnabotulinumtoxinA
2014
Completed Phase 4
~3600
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
1,037 Previous Clinical Trials
522,652 Total Patients Enrolled
AllerganLead Sponsor
781 Previous Clinical Trials
276,393 Total Patients Enrolled
ALLERGAN INC.Study DirectorAllergan
75 Previous Clinical Trials
79,283 Total Patients Enrolled