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Solriamfetol for Binge Eating Disorder (ENGAGE Trial)

Phase 3
Recruiting
Research Sponsored by Axsome Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Primary diagnosis of BED according to DSM-5 criteria
Male or female, aged 18 to 55 inclusive
Must not have
Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial

Summary

"This trial, called ENGAGE, is testing the effectiveness and safety of a drug called solriamfetol in treating binge eating disorder in adults. It is a Phase 3 trial, which

Who is the study for?
This trial is for adults with binge eating disorder (BED). Participants must not have other conditions that could interfere with the study, such as bulimia or other significant psychiatric disorders. They should be able to follow the trial procedures and take medication as directed.
What is being tested?
The ENGAGE trial is testing solriamfetol at two different doses (150 mg and 300 mg) against a placebo to see if it helps reduce binge eating episodes in adults. It's a Phase 3 study, meaning it's one of the final stages before potential approval for public use.
What are the potential side effects?
Solriamfetol may cause side effects like trouble sleeping, headaches, dry mouth, nausea, increased heart rate or blood pressure. The exact side effects can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Binge Eating Disorder.
Select...
I am between 18 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have previously taken solriamfetol/Sunosi.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: Solriamfetol 300 mgExperimental Treatment1 Intervention
Up to 12 weeks
Group II: Solriamfetol 150 mgExperimental Treatment1 Intervention
Up to 12 weeks
Group III: PlaceboPlacebo Group1 Intervention
Up to 12 weeks

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Who is running the clinical trial?

Axsome Therapeutics, Inc.Lead Sponsor
31 Previous Clinical Trials
10,477 Total Patients Enrolled
~300 spots leftby Dec 2025
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