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Botulinum Toxin
A Study to Assess Adverse Events of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar Lines
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 day 1 to day 126
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial tests AGN-151586, a new injection treatment for adults with noticeable frown lines between their eyebrows. The treatment works by weakening the muscles that cause these lines, helping to smooth out the skin. The study will check the safety and effectiveness of this treatment over several months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to day 126
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 126
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Electrocardiogram (ECG) Measurements
Change in Vital Sign Measurements
Number of Participants with Adverse Events
+1 moreSide effects data
From 2023 Phase 3 trial • 638 Patients • NCT052488676%
HEADACHE
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
AGN-151586
Placebo/None
Placebo/AGN-151586
AGN-151586/None
AGN-151586/AGN-151586
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: AGN-151586Experimental Treatment1 Intervention
Participants will receive 5 intramuscular injections in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may receive up to 2 additional cycles of open-label treatments.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AGN-151586
2022
Completed Phase 3
~2250
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
1,035 Previous Clinical Trials
522,058 Total Patients Enrolled
AllerganLead Sponsor
781 Previous Clinical Trials
275,699 Total Patients Enrolled
1 Trials studying Frown Lines
101 Patients Enrolled for Frown Lines
ALLERGAN INC.Study DirectorAllergan
75 Previous Clinical Trials
78,589 Total Patients Enrolled