Clinical trial Recruiting at 38 sites Phase 3 Interventional Ages 18 to 55

Investigating Solriamfetol for Binge Eating Disorder

Official title: A Phase 3, Randomized, Double-blind, Placebo-Controlled Trial of Solriamfetol in Adults With Binge Eating Disorder (BED)

Run by Axsome Therapeutics, Inc. · NCT06413433 · Data updated 2026-11-12

This study is testing if a new medication called solriamfetol can help adults with binge eating disorder reduce their binge eating episodes and improve their overall symptoms.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 55 Years
SexAll
Enrollment450 (estimated)
SponsorAxsome Therapeutics, Inc.
Industry-sponsored
Locations45 sites (Encino, California and 44 other locations)
StatusRecruiting
StartedApril 26, 2024
Main results expectedDecember 2026
Study endsDecember 2026
Registry record updatedJuly 28, 2026
Trial IDNCT06413433 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 to 55 who have a primary diagnosis of binge eating disorder as per DSM-5 criteria.

Probably not a fit

Patients who have previously been treated with solriamfetol or those deemed medically inappropriate for participation will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial evaluates the efficacy and safety of solriamfetol in treating adults with binge eating disorder (BED). Participants will be randomly assigned to receive either solriamfetol at doses of 150 mg or 300 mg, or a placebo, once daily for 12 weeks. The study aims to determine how well solriamfetol works in reducing binge eating episodes and improving overall symptoms associated with BED. Eligible participants must meet specific diagnostic criteria and provide informed consent before joining the trial.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce binge eating episodes and improve the quality of life for patients with BED.

How similar studies have gone: While this approach is novel in the context of BED, similar studies have shown promise in using pharmacological interventions for eating disorders.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Primary diagnosis of BED according to DSM-5 criteria.
* Provides written informed consent to participate in the study before the conduct of any study procedures.
* Male or female, aged 18 to 55 inclusive.

Exclusion Criteria:

* Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription.
* Unable to comply with study procedures.
* Medically inappropriate for study participation in the opinion of the investigator.

Where it's running

  • Clinical Research Site
    Encino, California, United States
    Recruiting
  • Clinical Research Site
    Garden Grove, California, United States
    Recruiting
  • Clinical Research Site
    Long Beach, California, United States
    Recruiting
  • Clinical Research Site
    Mission Viejo, California, United States
    Recruiting
  • Clinical Research Site
    Santa Ana, California, United States
    Recruiting
  • Clinical Research Site
    Walnut Creek, California, United States
    Recruiting
Show 39 more locations
  • Clinical Research Site
    West Covina, California, United States
    Recruiting
  • Clinical Research Site
    Colorado Springs, Colorado, United States
    Recruiting
  • Clinical Research Site
    Cromwell, Connecticut, United States
    Recruiting
  • Clinical Research Site
    Fort Myers, Florida, United States
    Recruiting
  • Clinical Research Site
    Jacksonville, Florida, United States
    Recruiting
  • Clinical Research Site
    Lauderhill, Florida, United States
    Recruiting
  • Clinical Research Site
    Miami, Florida, United States
    Recruiting
  • Clinical Research Site
    Miami, Florida, United States
    Recruiting
  • Clinical Research Site
    Miami Lakes, Florida, United States
    Recruiting
  • Clinical Research Site
    Orlando, Florida, United States
    Recruiting
  • Clinical Research Site
    Marietta, Georgia, United States
    Recruiting
  • Clinical Research Site
    Overland Park, Kansas, United States
    Recruiting
  • Clinical Research Site
    Boston, Massachusetts, United States
    Recruiting
  • Clinical Research Site
    Saint Charles, Missouri, United States
    Recruiting
  • Clinical Research Site
    Cherry Hill, New Jersey, United States
    Recruiting
  • Clinical Research Site
    Princeton, New Jersey, United States
    Recruiting
  • Clinical Research Site
    Mount Kisco, New York, United States
    Recruiting
  • Clinical Research Site
    New York, New York, United States
    Recruiting
  • Clinical Research Site
    Raleigh, North Carolina, United States
    Recruiting
  • Clinical Research Site
    Cincinnati, Ohio, United States
    Recruiting
  • Clinical Research Site
    Mason, Ohio, United States
    Recruiting
  • Clinical Research Site
    Middleburg Heights, Ohio, United States
    Recruiting
  • Clinical Research Site
    Portland, Oregon, United States
    Recruiting
  • Clinical Research Site
    Allentown, Pennsylvania, United States
    Recruiting
  • Clinical Research Site
    Media, Pennsylvania, United States
    Recruiting
  • Clinical Research Site
    Greenville, South Carolina, United States
    Recruiting
  • Clinical Research Site
    North Charleston, South Carolina, United States
    Recruiting
  • Clinical Research Site
    Memphis, Tennessee, United States
    Recruiting
  • Clinical Research Site
    Austin, Texas, United States
    Recruiting
  • Clinical Research Site
    Austin, Texas, United States
    Recruiting
  • Clinical Research Site
    Dallas, Texas, United States
    Recruiting
  • Clinical Research Site
    San Antonio, Texas, United States
    Recruiting
  • Clinical Research Site
    San Diego, California, United States
    Terminated
  • Clinical Research Site
    Clermont, Florida, United States
    Terminated
  • Clinical Research Site
    Miami Lakes, Florida, United States
    Terminated
  • Clinical Research Site
    Orlando, Florida, United States
    Terminated
  • Clinical Research Site
    Methuen, Massachusetts, United States
    Terminated
  • Clinical Research Site
    North Canton, Ohio, United States
    Terminated
  • Clinical Research Site
    Draper, Utah, United States
    Terminated

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.