Clinical Trial

A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder

Enrolling by Invitation Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 5 changes
critical Primary endpoint(s) modified 2026-08-12
notable Enrollment reduced: 300 -> 236 participants 2026-08-12
minor Trial arms changed: 1 -> 2 2026-08-12
notable Primary completion pushed: 2026-12 -> 2027-12 2026-08-12
minor Completion pushed: 2026-12 -> 2027-12 2026-08-12
Trial Details
NCT Number NCT06878976
Lead Sponsor Axsome Therapeutics, Inc.
Conditions Binge-Eating Disorder
Enrollment 236 participants
Start Date 2025-02-20
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-11