Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol

Last updated: January 21, 2025
Sponsor: Axsome Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Binge Eating Disorder

Bulimia

Treatment

Solriamfetol 150 mg

Placebo

Solriamfetol 300 mg

Clinical Study ID

NCT06413433
SOL-BED-301
  • Ages 18-55
  • All Genders

Study Summary

ENGAGE (Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of binge eating disorder (BED) in adults.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Primary diagnosis of BED according to DSM-5 criteria.

  • Provides written informed consent to participate in the study before the conduct ofany study procedures.

  • Male or female, aged 18 to 55 inclusive.

Exclusion

Exclusion Criteria:

  • Prior exposure to solriamfetol/Sunosi, through either a clinical study orprescription.

  • Unable to comply with study procedures.

  • Medically inappropriate for study participation in the opinion of the investigator.

Study Design

Total Participants: 450
Treatment Group(s): 3
Primary Treatment: Solriamfetol 150 mg
Phase: 3
Study Start date:
April 26, 2024
Estimated Completion Date:
December 31, 2025

Study Description

Eligible subjects must have a diagnosis of BED according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1:1 ratio to receive solriamfetol (150 or 300 mg) or placebo, once daily for 12 weeks.

Connect with a study center

  • Clinical Research Site

    Encino, California 91316
    United States

    Active - Recruiting

  • Clinical Research Site

    Garden Grove, California 92845
    United States

    Active - Recruiting

  • Clinical Research Site

    Long Beach, California 90806
    United States

    Active - Recruiting

  • Clinical Research Site

    Newport Beach, California 92660
    United States

    Active - Recruiting

  • Clinical Research Site

    San Diego, California 92103
    United States

    Active - Recruiting

  • Clinical Research Site

    Santa Ana, California 92705
    United States

    Active - Recruiting

  • Clinical Research Site

    Walnut Creek, California 94596
    United States

    Active - Recruiting

  • Clinical Research Site

    Colorado Springs, Colorado 80910
    United States

    Active - Recruiting

  • Clinical Research Site

    Cromwell, Connecticut 06416
    United States

    Active - Recruiting

  • Clinical Research Site

    Clermont, Florida 34711
    United States

    Active - Recruiting

  • Clinical Research Site

    Fort Myers, Florida 33912
    United States

    Active - Recruiting

  • Clinical Research Site

    Hialeah, Florida 33012
    United States

    Active - Recruiting

  • Clinical Research Site

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • Clinical Research Site

    Lauderhill, Florida 33319
    United States

    Active - Recruiting

  • Clinical Research Site

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Clinical Research Site

    Miami Lakes, Florida 33016
    United States

    Active - Recruiting

  • Clinical Research Site

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Clinical Research Site

    Marietta, Georgia 30060
    United States

    Active - Recruiting

  • Clinical Research Site

    Overland Park, Kansas 66210
    United States

    Active - Recruiting

  • Clinical Research Site

    Boston, Massachusetts 02131
    United States

    Active - Recruiting

  • Clinical Research Site

    Methuen, Massachusetts 01844
    United States

    Active - Recruiting

  • Clinical Research Site

    Saint Charles, Missouri 63304
    United States

    Active - Recruiting

  • Clinical Research Site

    Cherry Hill, New Jersey 08002
    United States

    Active - Recruiting

  • Clinical Research Site

    Princeton, New Jersey 08540
    United States

    Active - Recruiting

  • Clinical Research Site

    Mount Kisco, New York 10549
    United States

    Active - Recruiting

  • Clinical Research Site

    New York, New York 10128
    United States

    Active - Recruiting

  • Clinical Research Site

    Raleigh, North Carolina 27607
    United States

    Active - Recruiting

  • Clinical Research Site

    Cincinnati, Ohio 45215
    United States

    Active - Recruiting

  • Clinical Research Site

    Mason, Ohio 45040
    United States

    Active - Recruiting

  • Clinical Research Site

    Middleburg Heights, Ohio 44130
    United States

    Active - Recruiting

  • Clinical Research Site

    North Canton, Ohio 44720
    United States

    Active - Recruiting

  • Clinical Research Site

    Portland, Oregon 97210
    United States

    Active - Recruiting

  • Clinical Research Site

    Allentown, Pennsylvania 18104
    United States

    Active - Recruiting

  • Clinical Research Site

    Media, Pennsylvania 19063
    United States

    Active - Recruiting

  • Clinical Research Site

    Greenville, South Carolina 29615
    United States

    Active - Recruiting

  • Clinical Research Site

    North Charleston, South Carolina 29405
    United States

    Active - Recruiting

  • Clinical Research Site

    Memphis, Tennessee 38119
    United States

    Active - Recruiting

  • Clinical Research Site

    Austin, Texas 78731
    United States

    Active - Recruiting

  • Clinical Research Site

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Clinical Research Site

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Clinical Research Site

    Draper, Utah 84020
    United States

    Active - Recruiting

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