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Enrolling by invitationPhase 3

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

Key facts

Where
Anaheim, Atlanta, Austin, Boston, Brooklyn, Charleston, Chicago, Cromwell, Dallas, Duncansville, Hazelwood, Hollywood, Jacksonville, Knoxville, Lakeland, Las Vegas, Little Rock, Louisville, Memphis, Norcross, Oceanside, Orlando, Overland Park, Prairieville, Prosper, Redlands, Sacramento, Santa Ana, Springfield, Tampa, The Villages, Town and Country, Tulsa, Watertown, and Williamsville, United StatesSee the 35 sites
Phase
Phase 3

Where in United States

  • Anaheim, CaliforniaHospital not named in the registryNo longer taking part
  • Atlanta, GeorgiaHospital not named in the registryNo longer taking part
  • Austin, TexasHospital not named in the registryNo longer taking part
  • Boston, MassachusettsHospital not named in the registryNo longer taking part
  • Brooklyn, New YorkHospital not named in the registryNo longer taking part
  • Charleston, South CarolinaHospital not named in the registryNo longer taking part
  • Chicago, IllinoisHospital not named in the registryNo longer taking part
  • Cromwell, ConnecticutHospital not named in the registryNo longer taking part
  • Dallas, TexasHospital not named in the registryNo longer taking part
  • Duncansville, PennsylvaniaHospital not named in the registryNo longer taking part
  • Hazelwood, MissouriHospital not named in the registryNo longer taking part
  • Hollywood, FloridaHospital not named in the registryNo longer taking part
  • Jacksonville, FloridaHospital not named in the registryNo longer taking part
  • Knoxville, TennesseeHospital not named in the registryNo longer taking part
  • Lakeland, FloridaHospital not named in the registryNo longer taking part
  • Las Vegas, NevadaHospital not named in the registryNo longer taking part
  • Little Rock, ArkansasHospital not named in the registryNo longer taking part
  • Louisville, KentuckyHospital not named in the registryNo longer taking part
  • Memphis, TennesseeHospital not named in the registryNo longer taking part
  • Norcross, GeorgiaHospital not named in the registryNo longer taking part
  • Oceanside, CaliforniaHospital not named in the registryNo longer taking part
  • Orlando, FloridaHospital not named in the registryNo longer taking part
  • Overland Park, KansasHospital not named in the registryNo longer taking part
  • Prairieville, LouisianaHospital not named in the registryNo longer taking part
  • Prosper, TexasHospital not named in the registryNo longer taking part
  • Redlands, CaliforniaHospital not named in the registryNo longer taking part
  • Sacramento, CaliforniaHospital not named in the registryNo longer taking part
  • Santa Ana, CaliforniaHospital not named in the registryNo longer taking part
  • Springfield, MassachusettsHospital not named in the registryNo longer taking part
  • Tampa, FloridaHospital not named in the registryNo longer taking part
  • The Villages, FloridaHospital not named in the registryNo longer taking part
  • Town and Country, MissouriHospital not named in the registryNo longer taking part
  • Tulsa, OklahomaHospital not named in the registryNo longer taking part
  • Watertown, MassachusettsHospital not named in the registryNo longer taking part
  • Williamsville, New YorkHospital not named in the registryNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Axsome Therapeutics, Inc.
Trial code
NCT07637162
Record updated
6 November 2026
Original description
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.Read full original descriptionShow less

An Open-Label Study to Assess the Long-Term Safety and Efficacy of AXS-14 in the Management of Fibromyalgia

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.

Inclusion: Participation in AXS-14-FM-301.

Exclusion: Unable to comply with study procedures; Medically inappropriate for study participation in the opinion of the Investigator.

ClinicalTrials.gov NCT07637162