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

Enrolling by invitation · Phase 3

Conditions studied: Binge-Eating Disorder

In brief

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.

Key facts

Study ID

NCT06878976

Run by

Axsome Therapeutics, Inc.

People needed

300

Starts

2025-02-20

Expected to finish

2026-12-01

Last updated by the study team

2025-11-25

Who can join

Age: 18 and older, up to 56. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• 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
• Clinical Research Site — Miami, Florida, United States
• Clinical Research Site — Miami, Florida, United States
• Clinical Research Site — Orlando, Florida, United States
• Clinical Research Site — Marietta, Georgia, United States
• Clinical Research Site — Overland Park, Kansas, United States
• Clinical Research Site — Boston, Massachusetts, United States
• Clinical Research Site — Saint Charles, Missouri, United States
• Clinical Research Site — Cherry Hill, New Jersey, United States
• Clinical Research Site — Mount Kisco, New York, United States
• Clinical Research Site — New York, New York, United States
• Clinical Research Site — Raleigh, North Carolina, United States
• Clinical Research Site — Cincinnati, Ohio, United States
• Clinical Research Site — Mason, Ohio, United States
• Clinical Research Site — North Canton, Ohio, United States
• Clinical Research Site — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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