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Neuromodulator

BOTOX for Enlarged Jaw Muscles (MMP US P3 416 Trial)

Phase 3

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must have bilateral Grade 4 or Grade 5 Masseter Muscle Prominence (MMP) as determined by the investigator using the Masseter Muscle Prominence Scale (MMPS)

Participant must have bilateral Grade 4 or Grade 5 MMP as determined by the participant using the Masseter Muscle Prominence Scale - Participant (MMPS-P)

Must not have

History of or current temporomandibular disorder (TMJD), or presence of signs/symptoms of possible TMJD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 360

Awards & highlights

Pivotal Trial

Summary

This trial is testing the use of BOTOX injections to reduce the size of the masseter muscle in the lower face, which can sometimes look too wide. Participants will be divided into two groups,

Who is the study for?

Adults with Masseter Muscle Prominence, which causes a widened lower face, can join this study. They'll be randomly assigned to receive either BOTOX or a placebo injection. Participants must be willing to attend monthly visits and may have the option for additional BOTOX treatment.

What is being tested?

The trial is testing if BOTOX injections are safe and effective in reducing the size of masseter muscles compared to a placebo. It involves two periods: initial random assignment to BOTOX or placebo, followed by an optional phase where eligible participants can get more BOTOX treatments.

What are the potential side effects?

Possible side effects from BOTOX could include pain at the injection site, muscle weakness, bruising, headache, neck pain, eye problems like dryness or tearing up, and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My jaw muscles are very prominent, rated as the highest on a specific scale.

Select...

I have severe jaw muscle prominence as I rated myself on the MMPS-P.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have or might have jaw joint (TMJ) problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 360

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to day 360

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 360 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Composite Achievement of MMP Severity Improvement and at Least a 2-Grade Improvement from Baseline by Both Investigator-Rated MMPS and Participant-Rated MMPS-P

Number of Participants with Adverse Events (AEs)

Secondary study objectives

Change from Baseline in Lower Facial Shape Questionnaire-Impact Assessment (LFSQ-IA) Summary Score

Percentage of Participants Achieving Investigator-Rated MMPS Improvement Over Time

Percentage of Participants Achieving Participant-Rated MMPS-P Improvement Over Time

+2 more

Awards & Highlights

Pivotal Trial

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

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Open-Label Period: BOTOXExperimental Treatment1 Intervention

Participants who are eligible for re-treatment will receive BOTOX injections on either the Day 180, 210, 240, or 270 visit and will be followed for up to 6 months.

Group II: Double-Blind Period: BOTOXExperimental Treatment1 Intervention

Participants will receive BOTOX injections across both the right and left masseter muscle on Day 1.

Group III: Double-Blind Period: PlaceboPlacebo Group1 Intervention

Participants will receive placebo injections across both the right and left masseter muscle on Day 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BOTOX

2021

Completed Phase 4

~1890