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

August 7, 2026 updated by: Axsome Therapeutics, Inc.

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

236

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Encino, California, United States, 91316
        • Clinical Research Site
      • Long Beach, California, United States, 90806
        • Clinical Research Site
      • Santa Ana, California, United States, 92705
        • Clinical Research Site
      • Walnut Creek, California, United States, 94596
        • Clinical Research Site
      • West Covina, California, United States, 91790
        • Clinical Research Site
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
        • Clinical Research Site
    • Florida
      • Fort Myers, Florida, United States, 33912
        • Clinical Research Site
      • Jacksonville, Florida, United States, 32256
        • Clinical Research Site
      • Lauderhill, Florida, United States, 33319
        • Clinical Research Site
      • Miami, Florida, United States, 33145
        • Clinical Research Site
      • Miami, Florida, United States, 33176
        • Clinical Research Site
      • Miami Lakes, Florida, United States, 33016
        • Clinical Research Site
      • Orlando, Florida, United States, 32801
        • Clinical Research Site
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Clinical Research Site
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Clinical Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Clinical Research Site
    • Missouri
      • Saint Charles, Missouri, United States, 63304
        • Clinical Research Site
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08002
        • Clinical Research Site
    • New York
      • Mount Kisco, New York, United States, 10549
        • Clinical Research Site
      • New York, New York, United States, 10128
        • Clinical Research Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Clinical Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45215
        • Clinical Research Site
      • Mason, Ohio, United States, 45040
        • Clinical Research Site
      • Middleburg Heights, Ohio, United States, 44130
        • Clinical Research Site
      • North Canton, Ohio, United States, 44720
        • Clinical Research Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Clinical Research Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Clinical Research Site
    • South Carolina
      • North Charleston, South Carolina, United States, 29405
        • Clinical Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Clinical Research Site
    • Texas
      • Austin, Texas, United States, 78731
        • Clinical Research Site
      • Austin, Texas, United States, 78737
        • Clinical Research Site
      • Dallas, Texas, United States, 75251
        • Clinical Research Site
      • San Antonio, Texas, United States, 78229
        • Clinical Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Solriamfetol

Experimental: Solriamfetol

  • Up to 52 weeks in the combined open-label and open-label return segments;
  • Up to 24 weeks in the double-blind randomized withdrawal segment
Drug: Solriamfetol
Solriamfetol tablets, taken once daily
Placebo Comparator: Placebo
Up to 24 weeks in the double-blind randomized withdrawal segment
Drug: Placebo
Placebo tablets, taken once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time from randomization to relapse of binge eating in the RW segment
Time Frame: Up to 24 weeks
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axsome Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 14, 2025

First Submitted That Met QC Criteria

March 14, 2025

First Posted (Actual)

March 17, 2025

Study Record Updates

Last Update Posted (Actual)

August 11, 2026

Last Update Submitted That Met QC Criteria

August 7, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOL-BED-303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe