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NCT06413433PHASE3Recruiting

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

Axsome Therapeutics, Inc.

Start Date

4/26/2024

Completion Date

12/1/2026

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.

Detailed 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.

Eligibility Criteria

Age Range: 18 years to 55 years

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.

Interventions

DRUG

Solriamfetol 150 mg

DRUG

Solriamfetol 300 mg

DRUG

Placebo

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Conditions

Binge-Eating Disorder

Locations

Clinical Research Site

Encino, California 91316

United States

Clinical Research Site

Garden Grove, California 92845

United States

Clinical Research Site

Long Beach, California 90806

United States

Clinical Research Site

Mission Viejo, California 92691

United States

Clinical Research Site

San Diego, California 92103

United States

Clinical Research Site

Santa Ana, California 92705

United States

Clinical Research Site

Walnut Creek, California 94596

United States

Clinical Research Site

West Covina, California 91790

United States

Clinical Research Site

Colorado Springs, Colorado 80910

United States

Clinical Research Site

Cromwell, Connecticut 06416

United States

Clinical Research Site

Clermont, Florida 34711

United States

Clinical Research Site

Fort Myers, Florida 33912

United States

Clinical Research Site

Jacksonville, Florida 32256

United States

Clinical Research Site

Lauderhill, Florida 33319

United States

Clinical Research Site

Miami, Florida 33145

United States

Clinical Research Site

Miami, Florida 33176

United States

Clinical Research Site

Miami Lakes, Florida 33016

United States

Clinical Research Site

Miami Lakes, Florida 33016

United States

Clinical Research Site

Orlando, Florida 32801

United States

Clinical Research Site

Orlando, Florida 32806

United States

Clinical Research Site

Marietta, Georgia 30060

United States

Clinical Research Site

Overland Park, Kansas 66210

United States

Clinical Research Site

Boston, Massachusetts 02131

United States

Clinical Research Site

Methuen, Massachusetts 01844

United States

Clinical Research Site

Saint Charles, Missouri 63304

United States

Clinical Research Site

Cherry Hill, New Jersey 08002

United States

Clinical Research Site

Princeton, New Jersey 08540

United States

Clinical Research Site

Mount Kisco, New York 10549

United States

Clinical Research Site

New York, New York 10128

United States

Clinical Research Site

Raleigh, North Carolina 27607

United States

Clinical Research Site

Cincinnati, Ohio 45215

United States

Clinical Research Site

Mason, Ohio 45040

United States

Clinical Research Site

Middleburg Heights, Ohio 44130

United States

Clinical Research Site

North Canton, Ohio 44720

United States

Clinical Research Site

Portland, Oregon 97210

United States

Clinical Research Site

Allentown, Pennsylvania 18104

United States

Clinical Research Site

Media, Pennsylvania 19063

United States

Clinical Research Site

Greenville, South Carolina 29615

United States

Clinical Research Site

North Charleston, South Carolina 29405

United States

Clinical Research Site

Memphis, Tennessee 38119

United States

Clinical Research Site

Austin, Texas 73787

United States

Clinical Research Site

Austin, Texas 78731

United States

Clinical Research Site

Dallas, Texas 75231

United States

Clinical Research Site

San Antonio, Texas 78229

United States

Clinical Research Site

Draper, Utah 84020

United States