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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 450 (estimated) |
| Sponsor | Axsome Therapeutics, Inc. Industry-sponsored |
| Locations | 45 sites (Encino, California and 44 other locations) |
| Status | Recruiting |
| Started | April 26, 2024 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | July 28, 2026 |
| Trial ID | NCT06413433 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
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Encino, California, United States Recruiting -
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Garden Grove, California, United States Recruiting -
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Long Beach, California, United States Recruiting -
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Mission Viejo, California, United States Recruiting -
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Santa Ana, California, United States Recruiting -
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Walnut Creek, California, United States Recruiting
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West Covina, California, United States Recruiting -
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Colorado Springs, Colorado, United States Recruiting -
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Cromwell, Connecticut, United States Recruiting -
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Fort Myers, Florida, United States Recruiting -
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San Diego, California, United States Terminated -
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Clermont, Florida, United States Terminated -
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Orlando, Florida, United States Terminated -
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Methuen, Massachusetts, United States Terminated -
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North Canton, Ohio, United States Terminated -
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Draper, Utah, United States Terminated
Study contacts
- Study coordinator: Study Director
- Email: sol-bed-301@axsome.com
- Phone: 212-332-5061
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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E-diary vs Paper Diary in Binge Eating Disorder
This study tests whether an electronic diary and a paper diary capture binge eating episodes in the same way for adults with binge eating disorder.
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Four CBT-E formats for Binge Eating Disorder in adults
This trial tests four different psychotherapy formats to see which best reduces binge-eating episodes in adults with Binge Eating Disorder.
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Eating Disorder Dynamic Intervention
A digital program is tested to help adults with eating disorders by sending real-time, personalized coping tips based on smartphone surveys and sensor data.
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COR program for treating binge eating in Chilean adults
This project will try an eight-week online COR program to help adults in Chile who have recurrent binge-eating episodes.
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An AI chatbot to help teens and young adults with eating disorders manage anxiety about weight gain
This project will test an AI-powered chatbot that delivers exposure-based exercises to help adolescents and young adults in a partial hospitalization program reduce anxiety about weight gain.
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Digital cognitive-behavioral therapy plus mindfulness for binge eating
This pilot will test whether a 16-session guided digital program combining CBT and mindfulness with coaching helps adults with binge eating disorder more than coached self-monitoring.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.