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Enrolling by invitation

NCT Number: NCT06878976

A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder

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

Enrolling by invitation

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Key information

Conditions

Binge-Eating Disorder Feeding and Eating Disorders Mental Disorders

Age range

18 year–56 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research Site, Encino, California, United States

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About this study

This study includes three segments: Open-Label (OL), Double-Blind Randomized Withdrawal (RW), and Open-Label Return (OLR). Eligible subjects will have completed the SOL-BED-301 (ENGAGE) study. All subjects will receive open-label solriamfetol for up to 52 weeks during the OL segment. Subjects who enter the RW segment will be randomized 1:1 to either continue solriamfetol or switch to placebo for up to 24 weeks of double-blind treatment, followed by a return to open-label solriamfetol in the OLR segment. The overall duration of study treatment is up to 77 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Completion of the treatment period in Study SOL-BED-301.

Exclusion criteria

  • Unable to comply with study procedures.
  • Medically inappropriate for study participation in the opinion of the investigator.

Treatment and study plan

Solriamfetol

Drug

Solriamfetol tablets, taken once daily

Placebo

Drug

Placebo tablets, taken once daily

Primary outcomes

  1. Time from randomization to relapse of binge eating in the RW segment

    Time frame: Up to 24 weeks

Interested in participating?

Enrolling by invitation

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Axsome Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 17, 2025
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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