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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

Study Summary

This trial is testing a new product, AGN-151586, to see if it is safe and effective in treating wrinkles caused by facial expressions, like frowning. The trial will last 12 weeks and will enroll 300 participants who will be given either AGN-151586 or a placebo. The product will be administered as 5 intramuscular injections to the affected area on day 1, and participants may be retreated if necessary.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in ECG parameters

Change from baseline in Vital Sign Measurements

Change from baseline in laboratory evaluations

+3 more

Secondary outcome measures

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 2020 Phase 2 trial • 198 Patients • NCT04096326

14%

Headache

Facial pain

Nausea

Injection site pain

Vision blurred

Photophobia

Rash

Hypothyroidism

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 2: AGN-151586

Cohort 1: Placebo

Cohort 1: AGN-151586

Cohort 2: Placebo

Cohort 3: Placebo

Cohort 3: AGN-151586

Cohort 4: Placebo

Cohort 4: AGN-151586

Cohort 5: Placebo

Cohort 5: AGN-151586

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AllerganLead Sponsor

781 Previous Clinical Trials

276,260 Total Patients Enrolled

1 Trials studying Frown Lines

101 Patients Enrolled for Frown Lines

ALLERGAN INC.Study DirectorAllergan

75 Previous Clinical Trials

78,950 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are we looking to learn from this experiment?

"The study's sponsor, Allergan, has specified that the primary outcome will be Change from baseline in laboratory evaluations. This will be measured over a Up to 12 Weeks time span. Additionally, the study will measure secondary outcomes including Percentage of participants with achievement of Mostly Satisfied or Very Satisfied on the FLSQ Item 4 (natural look) for GL, Percentage of participants with ≥ 2-grade improvement from baseline on the FWS according to participant assessment of GL severity at maximum frown over the double-blind period, and Percentage of participants with ≥ 2-grade improvement from baseline on the FWS according to investigator assessment of GL severity"

Answered by AI

Could you provide information on the enrollment status of this clinical trial?

"No, this trial is not recruiting at the moment. The listing on clinicaltrials.gov shows that the study was last updated on November 1st, 2022. Although this study is not seeking patients anymore, there are 6 other studies currently enrolling participants at this time."

Answered by AI

Has AGN-151586 undergone FDA evaluation for safety and efficacy?

"AGN-151586's safety was given a 3 because this is a Phase 3 trial. This means that, while there is data supporting efficacy, there is also multiple rounds of data that support safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Toxin-Naïve Adult Participants With Glabellar Lines

2022. "A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Toxin-Naïve Adult Participants With Glabellar Lines". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05248880.