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

Phase 3

• Conditions: Binge-Eating Disorder
• Interventions: Drug: Solriamfetol 75mg, 150 mg, or 300 mg

• Registration Number: NCT06878976
• Lead Sponsor: Axsome Therapeutics, Inc.

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-week follow-up period.

Study Timeline

• Study Start: 2025-02-20
• Status Verified: 2025-03
• Study First Submitted: 2025-03-14
• Study First Submitted QC: 2025-03-14
• Last Update Submitted: 2025-03-14
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Completion of the treatment period in Study SOL-BED-301.
• Able to comply with study procedures.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Solriamfetol	Solriamfetol 75mg, 150 mg, or 300 mg	Up to 52 weeks.

Primary Outcome Measures

Name	Time	Method
Long-term Safety	Up to 52 weeks.	Incidence of treatment-emergent adverse events following dosing with solriamfetol

Trial Locations

Locations (1)

Clinical Research Site; 🇺🇸 Dallas, Texas, United States