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Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol

Study acronym: ENGAGE
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 2025 → Dec 2026
See other at-risk trials from Axsome Therapeutics, Inc.

Record History

  1. Notable Primary and study completion pushed from Dec 2025 to Dec 2026 Site details revised at 6 of 45 sitesv4 Show 1 more changeShow less
    • Site details revised at 6 of 45 sites
  2. Minor Study sites: 43 to 45v3
  3. Minor Study sites: 16 to 43v2
  4. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
ENGAGE (Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of binge eating disorder (BED) in adults.
Trial Details
NCT Number NCT06413433
Lead Sponsor Axsome Therapeutics, Inc.
Conditions Binge-Eating Disorder
Enrollment 450 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov