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RECRUITING
NCT06413433
PHASE3

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

Sponsor: Axsome Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Official title: A Phase 3, Randomized, Double-blind, Placebo-Controlled Trial of Solriamfetol in Adults With Binge Eating Disorder (BED)

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2024-04-26

Completion Date

2025-12

Last Updated

2025-11-21

Healthy Volunteers

No

Interventions

DRUG

Solriamfetol 150 mg

Solriamfetol tablets, taken once daily

DRUG

Solriamfetol 300 mg

Solriamfetol tablets, taken once daily

DRUG

Placebo

Placebo tablets, taken once daily

Locations (45)

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Encino, California, United States

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Garden Grove, California, United States

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Long Beach, California, United States

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Newport Beach, California, United States

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San Diego, California, United States

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Santa Ana, California, United States

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Walnut Creek, California, United States

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West Covina, California, United States

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Colorado Springs, Colorado, United States

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Cromwell, Connecticut, United States

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Clermont, Florida, United States

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Fort Myers, Florida, United States

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Hialeah, Florida, United States

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Jacksonville, Florida, United States

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Lauderhill, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami Lakes, Florida, United States

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Orlando, Florida, United States

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Orlando, Florida, United States

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Marietta, Georgia, United States

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Overland Park, Kansas, United States

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Boston, Massachusetts, United States

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Methuen, Massachusetts, United States

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Saint Charles, Missouri, United States

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Cherry Hill, New Jersey, United States

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Princeton, New Jersey, United States

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Mount Kisco, New York, United States

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New York, New York, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Mason, Ohio, United States

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Middleburg Heights, Ohio, United States

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North Canton, Ohio, United States

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Portland, Oregon, United States

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Allentown, Pennsylvania, United States

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Media, Pennsylvania, United States

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Greenville, South Carolina, United States

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North Charleston, South Carolina, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Draper, Utah, United States