๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-23

Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design (NCT07398417)

A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy and Safety of AXS-14 in the Management of Fibromyalgia

๐ŸŸข Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Axsome Therapeutics, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The study is a Phase 3, double-blind, placebo-controlled, randomized withdrawal study to assess the efficacy and safety of AXS-14 in the management of fibromyalgia.

Who can join: Review the eligibility criteria below.

Location: Clinical Research Site โ€” Glendale, Arizona

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (51 Sites)

Showing the first 25 of 51 sites.

  • Clinical Research Site โ€” Glendale, Arizona
  • Clinical Research Site โ€” Phoenix, Arizona
  • Clinical Research Site โ€” Tucson, Arizona
  • Clinical Research Site โ€” Little Rock, Arkansas
  • Clinical Research Site โ€” Anaheim, California
  • Clinical Research Site โ€” Oceanside, California
  • Clinical Research Site โ€” Redlands, California
  • Clinical Research Site โ€” Sacramento, California
  • Clinical Research Site โ€” Santa Ana, California
  • Clinical Research Site โ€” Cromwell, Connecticut
  • Clinical Research Site โ€” Hollywood, Florida
  • Clinical Research Site โ€” Jacksonville, Florida
  • Clinical Research Site โ€” Lakeland, Florida
  • Clinical Research Site โ€” Maitland, Florida
  • Clinical Research Site โ€” Orlando, Florida
  • Clinical Research Site โ€” Orlando, Florida
  • Clinical Research Site โ€” Tampa, Florida
  • Clinical Research Site โ€” The Villages, Florida
  • Clinical Research Site โ€” Atlanta, Georgia
  • Clinical Research Site โ€” Atlanta, Georgia
  • Clinical Research Site โ€” Marietta, Georgia
  • Clinical Research Site โ€” Norcross, Georgia
  • Clinical Research Site โ€” Chicago, Illinois
  • Clinical Research Site โ€” Tinley Park, Illinois
  • Clinical Research Site โ€” Overland Park, Kansas

๐Ÿ“ž Contact the Study Coordinator

Phone: (212) 332-5061

Email: AXS-14-FM-301@axsome.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Fibromyalgia clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—