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A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder
Sponsor: Axsome Therapeutics, Inc.
Summary
This is a Phase 3, multi-center, open-label and randomized withdrawal study to evaluate the long-term safety and efficacy of solriamfetol in the treatment of binge eating disorder (BED) in adults.
Official title: An Open-Label and Double-Blind, Randomized Withdrawal Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Adults With Binge Eating Disorder
Key Details
Gender
All
Age Range
18 Years - 56 Years
Study Type
INTERVENTIONAL
Enrollment
236
Start Date
2025-02-20
Completion Date
2027-12
Last Updated
2026-08-11
Healthy Volunteers
No
Conditions
Interventions
Solriamfetol
Solriamfetol tablets, taken once daily
Placebo
Placebo tablets, taken once daily
Locations (33)
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Encino, California, United States
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Long Beach, 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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Cromwell, Connecticut, United States
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Fort Myers, 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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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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Saint Charles, Missouri, United States
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Cherry Hill, 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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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