NCT06878976

Open-Label Safety Study of Solriamfetol in Subjects With Binge Eating Disorder

An Open-Label Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Adults With Binge Eating Disorder

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Axsome Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 56 Years
• Healthy volunteers: Not accepted

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-week follow-up period.

Conditions

• Binge-Eating Disorder

Interventions

Type	Name	Description
DRUG	Solriamfetol 75mg, 150 mg, or 300 mg	Taken once daily.

Timeline

• Start date: 2025-02-20
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-03-17
• Last updated: 2025-11-25

Locations

31 sites across 1 country: United States

Regulatory

• FDA-regulated drug study