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Investigating Solriamfetol for Binge Eating Disorder

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

Phase 3 Interventional Axsome Therapeutics, Inc. · NCT06413433

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
Enrollment450 (estimated)
Ages18 Years to 55 Years
SexAll
SponsorAxsome Therapeutics, Inc. Industry-sponsored
Locations45 sites (Encino, California and 44 other locations)
Trial IDNCT06413433 on ClinicalTrials.gov

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.

Who should consider this trial

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

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

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

Eligibility criteria

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 this trial is running

Encino, California and 44 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Binge-Eating DisorderBinge eating disorderBEDSolriamfetolSunosiAxsomeNon-stimulant therapyDopamine norepinephrine reuptake inhibitor
Last reviewed 2026-06-13 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.