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Neuromodulator

BOTOX for Prominent Jaw Muscles

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 looking at using BOTOX injections to treat the prominence of the masseter muscle in the lower face. The study will involve approximately 200 adult participants who will receive injections of either B

Who is the study for?

Adults with Masseter Muscle Prominence, which causes a widened lower face, can join this study. They must be willing to receive injections and attend monthly visits at the clinic or hospital. People who don't meet these requirements or have conditions that could interfere with the trial may not participate.

What is being tested?

The trial is testing BOTOX injections against a placebo to see if they can safely reduce the size of masseter muscles in adults. Participants are randomly assigned to get either BOTOX or a placebo, with a follow-up period where eligible participants might receive additional BOTOX treatments.

What are the potential side effects?

Possible side effects from BOTOX may include pain at the injection site, muscle weakness, bruising, headache, and rarely more serious effects like spread of toxin effects away from the injection site.

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.

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

2013

Completed Phase 4

~1410