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Open-Label Safety Study of Solriamfetol in Subjects With Binge Eating Disorder | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATIONPHASE3

Open-Label Safety Study of Solriamfetol in Subjects With Binge Eating Disorder

An Open-Label Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Adults With Binge Eating Disorder

NCT06878976•Axsome Therapeutics, Inc.

Summary

This is a Phase 3, multi-center, open-label study to evaluate the long-term safety and efficacy of solriamfetol in the treatment of binge eating disorder (BED) in adults.

Detailed Description

Eligible subjects will have previously completed the SOL-BED-301 (ENGAGE) study. This study consists of a Baseline Visit, a 2-week Titration Phase, and a 50-week Maintenance Phase, followed by a 1-week follow-up period.

Eligibility

Age

18 - 56 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Completion of the treatment period in Study SOL-BED-301.
•Able to comply with study procedures.

Exclusion Criteria

•Significant change in vital signs, medical history or concomitant medications since enrolling in the SOL-BED-301 study which, in the opinion of the Investigator or the Medical Monitor, would render the subject unsuitable to receive solriamfetol or participate in the study.

Locations (31)

Clinical Research Site

Encino, California, United States

Clinical Research Site

Long Beach, California, United States

Clinical Research Site

Santa Ana, California, United States

Clinical Research Site

Walnut Creek, California, United States

Clinical Research Site

West Covina, California, United States

Clinical Research Site

Cromwell, Connecticut, United States

Clinical Research Site

Fort Myers, Florida, United States

Clinical Research Site

Hialeah, Florida, United States

Clinical Research Site

Jacksonville, Florida, United States

Clinical Research Site

Lauderhill, Florida, United States

Key Dates

Start Date

February 20, 2025

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

November 25, 2025

Enrollment

300

ESTIMATED participants

Conditions

Binge-Eating Disorder

Interventions

Solriamfetol 75mg, 150 mg, or 300 mg

DRUG

Building an Equitable and Accessible System of Eating Disorder Care for VA, DoD, and Underrepresented Americans

NCT05304104

Binge-Eating DisorderBulimia Nervosa+2 more

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RECRUITINGNA

Preventing Type 2 Diabetes in Black Emergent Adult

NCT06848244

Type 2 Diabetes MellitusBinge-Eating Disorder+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Open-Label Safety Study of Solriamfetol in Subjects With Binge Eating Disorder

Inclusion Criteria

Exclusion Criteria

Building an Equitable and Accessible System of Eating Disorder Care for VA, DoD, and Underrepresented Americans

Preventing Type 2 Diabetes in Black Emergent Adult

Relationships Between Exercise and Appetite in Women With Loss of Control Eating

Profiling the Dynamic of Binge Eating Disorder (PRODY-BED)

Pilot Study on the Validity of the Metacognitive Hub Model of Craving in Bulimia Nervosa (BN) and Binge Eating Disorders (BED)

PROspective Longitudinal All-comer Inclusion Study in Eating Disorders