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
Trial Snapshot
- Phase
- Phase 3
- Status
- Enrolling By Invitation
- Sponsor
- Axsome Therapeutics, Inc.
- Enrollment
- 236
- Locations
- 33
- Primary Endpoint
- Time from randomization to relapse of binge eating in the RW segment
Study Overview
Brief 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.
Detailed Description
This study includes three segments: Open-Label (OL), Double-Blind Randomized Withdrawal (RW), and Open-Label Return (OLR). Eligible subjects will have completed the SOL-BED-301 (ENGAGE) study. All subjects will receive open-label solriamfetol for up to 52 weeks during the OL segment. Subjects who enter the RW segment will be randomized 1:1 to either continue solriamfetol or switch to placebo for up to 24 weeks of double-blind treatment, followed by a return to open-label solriamfetol in the OLR segment. The overall duration of study treatment is up to 77 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 56 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Completion of the treatment period in Study SOL-BED-301.
Exclusion Criteria
- •Unable to comply with study procedures.
- •Medically inappropriate for study participation in the opinion of the investigator.
Arms & Interventions
Solriamfetol
Experimental: Solriamfetol
- Up to 52 weeks in the combined open-label and open-label return segments;
- Up to 24 weeks in the double-blind randomized withdrawal segment
Intervention: Solriamfetol (Drug)
Placebo
Up to 24 weeks in the double-blind randomized withdrawal segment
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Time from randomization to relapse of binge eating in the RW segment
Time Frame: Up to 24 weeks
Secondary Outcomes
No secondary outcomes reported