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

Last updated: November 20, 2025
Sponsor: Axsome Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Binge Eating Disorder

Bulimia

Treatment

Placebo

Solriamfetol 300 mg

Solriamfetol 150 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: Placebo
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

    Site Not Available

  • Clinical Research Site

    Garden Grove, California 92845
    United States

    Site Not Available

  • Clinical Research Site

    Long Beach, California 90806
    United States

    Site Not Available

  • Clinical Research Site

    Newport Beach, California 92660
    United States

    Site Not Available

  • Clinical Research Site

    San Diego, California 92103
    United States

    Site Not Available

  • Clinical Research Site

    Santa Ana, California 92705
    United States

    Site Not Available

  • Clinical Research Site

    Walnut Creek, California 94596
    United States

    Site Not Available

  • Clinical Research Site

    Encino 5346649, California 5332921 91316
    United States

    Active - Recruiting

  • Clinical Research Site

    Garden Grove 5351515, California 5332921 92845
    United States

    Active - Recruiting

  • Clinical Research Site

    Long Beach 5367929, California 5332921 90806
    United States

    Active - Recruiting

  • Clinical Research Site

    Newport Beach 5376890, California 5332921 92660
    United States

    Active - Recruiting

  • Clinical Research Site

    San Diego 5391811, California 5332921 92103
    United States

    Terminated

  • Clinical Research Site

    Santa Ana 5392900, California 5332921 92705
    United States

    Active - Recruiting

  • Clinical Research Site

    Walnut Creek 5406990, California 5332921 94596
    United States

    Active - Recruiting

  • Clinical Research Site

    West Covina 5407933, California 5332921 91790
    United States

    Active - Recruiting

  • Clinical Research Site

    Colorado Springs, Colorado 80910
    United States

    Site Not Available

  • Clinical Research Site

    Colorado Springs 5417598, Colorado 5417618 80910
    United States

    Active - Recruiting

  • Clinical Research Site

    Cromwell, Connecticut 06416
    United States

    Site Not Available

  • Clinical Research Site

    Cromwell 4832121, Connecticut 4831725 06416
    United States

    Active - Recruiting

  • Clinical Research Site

    Clermont, Florida 34711
    United States

    Site Not Available

  • Clinical Research Site

    Fort Myers, Florida 33912
    United States

    Site Not Available

  • Clinical Research Site

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Clinical Research Site

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Clinical Research Site

    Lauderhill, Florida 33319
    United States

    Site Not Available

  • Clinical Research Site

    Miami, Florida 33176
    United States

    Site Not Available

  • Clinical Research Site

    Miami Lakes, Florida 33016
    United States

    Site Not Available

  • Clinical Research Site

    Orlando, Florida 32801
    United States

    Site Not Available

  • Clinical Research Site

    Clermont 4151352, Florida 4155751 34711
    United States

    Terminated

  • Clinical Research Site

    Fort Myers 4155995, Florida 4155751 33912
    United States

    Active - Recruiting

  • Clinical Research Site

    Hialeah 4158476, Florida 4155751 33012
    United States

    Active - Recruiting

  • Clinical Research Site

    Jacksonville 4160021, Florida 4155751 32256
    United States

    Active - Recruiting

  • Clinical Research Site

    Lauderhill 4161625, Florida 4155751 33319
    United States

    Active - Recruiting

  • Clinical Research Site

    Miami 4164138, Florida 4155751 33145
    United States

    Active - Recruiting

  • Clinical Research Site

    Miami Lakes 4164186, Florida 4155751 33016
    United States

    Terminated

  • Clinical Research Site

    Orlando 4167147, Florida 4155751 32801
    United States

    Active - Recruiting

  • Clinical Research Site

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Clinical Research Site

    Marietta 4207783, Georgia 4197000 30060
    United States

    Active - Recruiting

  • Clinical Research Site

    Overland Park, Kansas 66210
    United States

    Site Not Available

  • Clinical Research Site

    Overland Park 4276873, Kansas 4273857 66210
    United States

    Active - Recruiting

  • Clinical Research Site

    Boston, Massachusetts 02131
    United States

    Site Not Available

  • Clinical Research Site

    Methuen, Massachusetts 01844
    United States

    Site Not Available

  • Clinical Research Site

    Boston 4930956, Massachusetts 6254926 02131
    United States

    Active - Recruiting

  • Clinical Research Site

    Methuen 4943828, Massachusetts 6254926 01844
    United States

    Terminated

  • Clinical Research Site

    Saint Charles, Missouri 63304
    United States

    Site Not Available

  • Clinical Research Site

    Saint Charles 4406831, Missouri 4398678 63304
    United States

    Active - Recruiting

  • Clinical Research Site

    Cherry Hill, New Jersey 08002
    United States

    Site Not Available

  • Clinical Research Site

    Princeton, New Jersey 08540
    United States

    Site Not Available

  • Clinical Research Site

    Cherry Hill 4501198, New Jersey 5101760 08002
    United States

    Active - Recruiting

  • Clinical Research Site

    Princeton 5102922, New Jersey 5101760 08540
    United States

    Active - Recruiting

  • Clinical Research Site

    Mount Kisco, New York 10549
    United States

    Site Not Available

  • Clinical Research Site

    New York, New York 10128
    United States

    Site Not Available

  • Clinical Research Site

    Mount Kisco 5127744, New York 5128638 10549
    United States

    Active - Recruiting

  • Clinical Research Site

    New York 5128581, New York 5128638 10128
    United States

    Active - Recruiting

  • Clinical Research Site

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Clinical Research Site

    Raleigh 4487042, North Carolina 4482348 27607
    United States

    Active - Recruiting

  • Clinical Research Site

    Cincinnati, Ohio 45215
    United States

    Site Not Available

  • Clinical Research Site

    Mason, Ohio 45040
    United States

    Site Not Available

  • Clinical Research Site

    Middleburg Heights, Ohio 44130
    United States

    Site Not Available

  • Clinical Research Site

    North Canton, Ohio 44720
    United States

    Site Not Available

  • Clinical Research Site

    Cincinnati 4508722, Ohio 5165418 45215
    United States

    Active - Recruiting

  • Clinical Research Site

    Mason 4517698, Ohio 5165418 45040
    United States

    Active - Recruiting

  • Clinical Research Site

    Middleburg Heights 5162851, Ohio 5165418 44130
    United States

    Active - Recruiting

  • Clinical Research Site

    North Canton 5164706, Ohio 5165418 44720
    United States

    Terminated

  • Clinical Research Site

    Portland, Oregon 97210
    United States

    Site Not Available

  • Clinical Research Site

    Portland 5746545, Oregon 5744337 97210
    United States

    Active - Recruiting

  • Clinical Research Site

    Allentown, Pennsylvania 18104
    United States

    Site Not Available

  • Clinical Research Site

    Media, Pennsylvania 19063
    United States

    Site Not Available

  • Clinical Research Site

    Allentown 5178127, Pennsylvania 6254927 18104
    United States

    Active - Recruiting

  • Clinical Research Site

    Media 4559575, Pennsylvania 6254927 19063
    United States

    Active - Recruiting

  • Clinical Research Site

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Clinical Research Site

    North Charleston, South Carolina 29405
    United States

    Site Not Available

  • Clinical Research Site

    Greenville 4580543, South Carolina 4597040 29615
    United States

    Active - Recruiting

  • Clinical Research Site

    North Charleston 4589387, South Carolina 4597040 29405
    United States

    Active - Recruiting

  • Clinical Research Site

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Clinical Research Site

    Memphis 4641239, Tennessee 4662168 38119
    United States

    Active - Recruiting

  • Clinical Research Site

    Austin, Texas 78731
    United States

    Site Not Available

  • Clinical Research Site

    Dallas, Texas 75231
    United States

    Site Not Available

  • Clinical Research Site

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Clinical Research Site

    Austin 4671654, Texas 4736286 78731
    United States

    Active - Recruiting

  • Clinical Research Site

    Dallas 4684888, Texas 4736286 75231
    United States

    Active - Recruiting

  • Clinical Research Site

    San Antonio 4726206, Texas 4736286 78229
    United States

    Active - Recruiting

  • Clinical Research Site

    Draper, Utah 84020
    United States

    Site Not Available

  • Clinical Research Site

    Draper 5774001, Utah 5549030 84020
    United States

    Terminated

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