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

NCT ID: NCT06413433

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-26

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Binge-Eating Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Solriamfetol 150 mg

Up to 12 weeks

Group Type EXPERIMENTAL

Solriamfetol 150 mg

Intervention Type DRUG

Solriamfetol tablets, taken once daily

Solriamfetol 300 mg

Up to 12 weeks

Group Type EXPERIMENTAL

Solriamfetol 300 mg

Intervention Type DRUG

Solriamfetol tablets, taken once daily

Placebo

Up to 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets, taken once daily

Interventions

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Solriamfetol 150 mg

Solriamfetol tablets, taken once daily

Intervention Type DRUG

Solriamfetol 300 mg

Solriamfetol tablets, taken once daily

Intervention Type DRUG

Placebo

Placebo tablets, taken once daily

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Axsome Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Research Site

Encino, California, United States

Site Status RECRUITING

Clinical Research Site

Garden Grove, California, United States

Site Status RECRUITING

Clinical Research Site

Long Beach, California, United States

Site Status RECRUITING

Clinical Research Site

Newport Beach, California, United States

Site Status RECRUITING

Clinical Research Site

San Diego, California, United States

Site Status TERMINATED

Clinical Research Site

Santa Ana, California, United States

Site Status RECRUITING

Clinical Research Site

Walnut Creek, California, United States

Site Status RECRUITING

Clinical Research Site

West Covina, California, United States

Site Status RECRUITING

Clinical Research Site

Colorado Springs, Colorado, United States

Site Status RECRUITING

Clinical Research Site

Cromwell, Connecticut, United States

Site Status RECRUITING

Clinical Research Site

Clermont, Florida, United States

Site Status TERMINATED

Clinical Research Site

Fort Myers, Florida, United States

Site Status RECRUITING

Clinical Research Site

Hialeah, Florida, United States

Site Status RECRUITING

Clinical Research Site

Jacksonville, Florida, United States

Site Status RECRUITING

Clinical Research Site

Lauderhill, Florida, United States

Site Status RECRUITING

Clinical Research Site

Miami, Florida, United States

Site Status RECRUITING

Clinical Research Site

Miami, Florida, United States

Site Status RECRUITING

Clinical Research Site

Miami Lakes, Florida, United States

Site Status TERMINATED

Clinical Research Site

Orlando, Florida, United States

Site Status RECRUITING

Clinical Research Site

Orlando, Florida, United States

Site Status TERMINATED

Clinical Research Site

Marietta, Georgia, United States

Site Status RECRUITING

Clinical Research Site

Overland Park, Kansas, United States

Site Status RECRUITING

Clinical Research Site

Boston, Massachusetts, United States

Site Status RECRUITING

Clinical Research Site

Methuen, Massachusetts, United States

Site Status TERMINATED

Clinical Research Site

Saint Charles, Missouri, United States

Site Status RECRUITING

Clinical Research Site

Cherry Hill, New Jersey, United States

Site Status RECRUITING

Clinical Research Site

Princeton, New Jersey, United States

Site Status RECRUITING

Clinical Research Site

Mount Kisco, New York, United States

Site Status RECRUITING

Clinical Research Site

New York, New York, United States

Site Status RECRUITING

Clinical Research Site

Raleigh, North Carolina, United States

Site Status RECRUITING

Clinical Research Site

Cincinnati, Ohio, United States

Site Status RECRUITING

Clinical Research Site

Mason, Ohio, United States

Site Status RECRUITING

Clinical Research Site

Middleburg Heights, Ohio, United States

Site Status RECRUITING

Clinical Research Site

North Canton, Ohio, United States

Site Status TERMINATED

Clinical Research Site

Portland, Oregon, United States

Site Status RECRUITING

Clinical Research Site

Allentown, Pennsylvania, United States

Site Status RECRUITING

Clinical Research Site

Media, Pennsylvania, United States

Site Status RECRUITING

Clinical Research Site

Greenville, South Carolina, United States

Site Status RECRUITING

Clinical Research Site

North Charleston, South Carolina, United States

Site Status RECRUITING

Clinical Research Site

Memphis, Tennessee, United States

Site Status RECRUITING

Clinical Research Site

Austin, Texas, United States

Site Status RECRUITING

Clinical Research Site

Austin, Texas, United States

Site Status RECRUITING

Clinical Research Site

Dallas, Texas, United States

Site Status RECRUITING

Clinical Research Site

San Antonio, Texas, United States

Site Status RECRUITING

Clinical Research Site

Draper, Utah, United States

Site Status TERMINATED

Countries

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United States

Central Contacts

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Study Director

Role: CONTACT

212-332-5061

Related Links

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http://www.axsome.com

Axsome Therapeutics Website

https://www.EngageBED.com

ENGAGE Study Website

Other Identifiers

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SOL-BED-301

Identifier Type: -

Identifier Source: org_study_id

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