Status:
ENROLLING_BY_INVITATION
Open-Label Safety Study of Solriamfetol in Subjects With Binge Eating Disorder
Lead Sponsor:
Axsome Therapeutics, Inc.
Conditions:
Binge-Eating Disorder
Eligibility:
All Genders
18-56 years
Phase:
PHASE3
Brief Summary
This is a Phase 3, multi-center, open-label study to evaluate the long-term safety and efficacy of solriamfetol in the treatment of binge eating disorder (BED) in adults.
Detailed Description
Eligible subjects will have previously completed the SOL-BED-301 (ENGAGE) study. This study consists of a Baseline Visit, a 2-week Titration Phase, and a 50-week Maintenance Phase, followed by a 1-we...
Eligibility Criteria
Inclusion
- Completion of the treatment period in Study SOL-BED-301.
- Able to comply with study procedures.
Exclusion
- Significant change in vital signs, medical history or concomitant medications since enrolling in the SOL-BED-301 study which, in the opinion of the Investigator or the Medical Monitor, would render the subject unsuitable to receive solriamfetol or participate in the study.
Key Trial Info
Start Date :
February 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06878976
Start Date
February 20 2025
End Date
December 1 2026
Last Update
November 25 2025
Active Locations (31)
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1
Clinical Research Site
Encino, California, United States, 91316
2
Clinical Research Site
Long Beach, California, United States, 90806
3
Clinical Research Site
Santa Ana, California, United States, 92705
4
Clinical Research Site
Walnut Creek, California, United States, 94596