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Neurotoxin

AGN-151586 for Frown Lines

Phase 3

Waitlist Available

Research Sponsored by Allergan

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 hour 24

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new treatment called AGN-151586 for reducing wrinkles between the eyebrows in adults who haven't used similar treatments before. The treatment works by weakening the muscles that cause these wrinkles. Participants will receive injections and be monitored for a few months to see if the treatment is safe and effective.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ hour 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~hour 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and hour 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in ECG parameters

Change from baseline in Vital Sign Measurements

Change from baseline in laboratory evaluations

+3 more

Secondary study objectives

Percentage of participants with achievement of Mostly Satisfied or Very Satisfied on the FLSQ Item 4 (natural look) for GL

Percentage of participants with achievement of Mostly Satisfied or Very Satisfied on the FLSQ Item 5 (overall satisfaction) for GL

Percentage of participants with achievement of Mostly Satisfied or Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Item 5 (overall satisfaction) for GL

+2 more

Side effects data

From 2023 Phase 3 trial • 638 Patients • NCT05248867

HEADACHE

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

AGN-151586

Placebo/None

Placebo/AGN-151586

AGN-151586/None

AGN-151586/AGN-151586

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: PlaceboExperimental Treatment2 Interventions

Participants will receive 5 intramuscular injections of Placebo in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.

Group II: AGN-151586Experimental Treatment1 Intervention

Participants will receive 5 intramuscular injections of AGN-151586 in the glabellar complex on Day 1. Based on meeting the retreatment criteria, the participant may also receive 1 open-label treatment of AGN-151586.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AGN-151586

2022

Completed Phase 3

~2250

Placebo

1995

Completed Phase 3

~2670