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Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia

StatusEnrolling by Invitation
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 18 → 31 locationsv3
  2. Trial sites expanded: 8 → 18 locationsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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, 52-week, open-label trial to evaluate the long-term safety and efficacy of AXS-14 in the management of fibromyalgia.
Trial Details
NCT Number NCT07637162
Lead Sponsor Axsome Therapeutics, Inc.
Conditions Fibromyalgia
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov