Recruiting
Phase 3

Solriamfetol

Sponsor:

Axsome Therapeutics, Inc.

Code:

NCT06413433

Conditions

Binge-Eating Disorder

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Solriamfetol 150 mg

Solriamfetol 300 mg

Placebo

Study Details

Brief 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.

Conditions

Binge-Eating Disorder

Study ID

NCT06413433

Start date

Apr 26, 2024

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Primary diagnosis of BED according to DSM-5 criteria.
  • Provides written informed consent to participate in the study before the conduct of any study procedures.
  • Male or female, aged 18 to 55 inclusive.

Exclusion Criteria:

  • Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription.
  • Unable to comply with study procedures.
  • Medically inappropriate for study participation in the opinion of the investigator.

Study Design

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Solriamfetol 150 mg

Up to 12 weeks

experimental: Solriamfetol 300 mg

Up to 12 weeks

placebo comparator: Placebo

Up to 12 weeks

Interventions

Solriamfetol 150 mg

Solriamfetol tablets, taken once daily

Solriamfetol 300 mg

Solriamfetol tablets, taken once daily

Placebo

Placebo tablets, taken once daily

Primary outcome measure

  • Change from Baseline to Week 12 in number of binge eating episodes [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Study Director

212-332-5061sol-bed-301@axsome.com

Locations

Clinical Research Site

Recruiting

Encino, California, United States, 91316

Clinical Research Site

Recruiting

Garden Grove, California, United States, 92845

Clinical Research Site

Recruiting

Long Beach, California, United States, 90806

Clinical Research Site

Recruiting

Mission Viejo, California, United States, 92691

Clinical Research Site

Recruiting

Santa Ana, California, United States, 92705

Clinical Research Site

Recruiting

Walnut Creek, California, United States, 94596

Clinical Research Site

Recruiting

West Covina, California, United States, 91790

Clinical Research Site

Recruiting

Colorado Springs, Colorado, United States, 80910

Clinical Research Site

Recruiting

Cromwell, Connecticut, United States, 06416

Clinical Research Site

Recruiting

Fort Myers, Florida, United States, 33912

Clinical Research Site

Recruiting

Jacksonville, Florida, United States, 32256

Clinical Research Site

Recruiting

Lauderhill, Florida, United States, 33319

Clinical Research Site

Recruiting

Miami, Florida, United States, 33145

Clinical Research Site

Recruiting

Miami, Florida, United States, 33176

Clinical Research Site

Recruiting

Miami Lakes, Florida, United States, 33016

Clinical Research Site

Recruiting

Orlando, Florida, United States, 32801

Clinical Research Site

Recruiting

Marietta, Georgia, United States, 30060

Clinical Research Site

Recruiting

Overland Park, Kansas, United States, 66210

Clinical Research Site

Recruiting

Boston, Massachusetts, United States, 02131

Clinical Research Site

Recruiting

Saint Charles, Missouri, United States, 63304

Clinical Research Site

Recruiting

Cherry Hill, New Jersey, United States, 08002

Clinical Research Site

Recruiting

Princeton, New Jersey, United States, 08540

Clinical Research Site

Recruiting

Mount Kisco, New York, United States, 10549

Clinical Research Site

Recruiting

New York, New York, United States, 10128

Clinical Research Site

Recruiting

Raleigh, North Carolina, United States, 27607

Clinical Research Site

Recruiting

Cincinnati, Ohio, United States, 45215

Clinical Research Site

Recruiting

Mason, Ohio, United States, 45040

Clinical Research Site

Recruiting

Middleburg Heights, Ohio, United States, 44130

Clinical Research Site

Recruiting

Portland, Oregon, United States, 97210

Clinical Research Site

Recruiting

Allentown, Pennsylvania, United States, 18104

Clinical Research Site

Recruiting

Media, Pennsylvania, United States, 19063

Clinical Research Site

Recruiting

Greenville, South Carolina, United States, 29615

Clinical Research Site

Recruiting

North Charleston, South Carolina, United States, 29405

Clinical Research Site

Recruiting

Memphis, Tennessee, United States, 38119

Clinical Research Site

Recruiting

Austin, Texas, United States, 73787

Clinical Research Site

Recruiting

Austin, Texas, United States, 78731

Clinical Research Site

Recruiting

Dallas, Texas, United States, 75231

Clinical Research Site

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

Axsome Therapeutics, Inc.

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Keywords

  • Binge eating disorder
  • BED
  • Solriamfetol
  • Sunosi
  • Axsome
  • Non-stimulant therapy
  • Dopamine norepinephrine reuptake inhibitor
  • Trace amine-associated receptor 1 (TAAR1) agonist

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Axsome Therapeutics, Inc. on 2026-07-28.