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

StatusEnrolling by Invitation
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 2026 → Dec 2027
Primary endpoint reworded 1 of 1 changed
Enrollment reduced 21% 300 → 236 participants
See other at-risk trials from Axsome Therapeutics, Inc.

Record History

  1. Primary and study completion pushed from Dec 2026 to Dec 2027 Primary endpoint(s) modified · Enrollment reduced: 300 → 236 participants · Trial arms changed: 1 → 2 · 5 morev3 Show 8 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment reduced: 300 → 236 participants
    • Trial arms changed: 1 → 2
    • Study sites: 31 to 33
    • Interventions: Solriamfetol 75mg, 150 mg, or 300 mg (Drug) to Placebo (Drug), Solriamfetol (Drug)
    • Eligibility criteria shortened, about 29 words
    • Study description expanded, about 55 words
    • Study title expanded, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 18 to 31v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06878976
Lead Sponsor Axsome Therapeutics, Inc.
Conditions Binge-Eating Disorder
Enrollment 236 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov