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

November 20, 2025 updated by: Axsome Therapeutics, Inc.

An Open-Label 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 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

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.

Study Type

Interventional

Enrollment (Estimated)

300

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
      • Hialeah, Florida, United States, 33012
        • 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
      • 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
      • North Canton, Ohio, United States, 44720
        • Clinical Research Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • 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.
  • 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.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Solriamfetol
Up to 52 weeks.
Drug: Solriamfetol 75mg, 150 mg, or 300 mg
Taken once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term Safety
Time Frame: Up to 52 weeks.
Incidence of treatment-emergent adverse events following dosing with solriamfetol
Up to 52 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, 2026

Study Completion (Estimated)

December 1, 2026

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)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOL-BED-303

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.

Clinical Trials on Binge-Eating Disorder

Clinical Trials on Solriamfetol 75mg, 150 mg, or 300 mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe