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Enrolling by invitationPhase 3

AXS-14 for long-term fibromyalgia care, checked for safety

Tests AXS-14 over a long period in adults with fibromyalgia.

Key facts

Who runs it
Axsome Therapeutics, Inc.
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
Trial code
Registry title
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Status
Enrolling by invitation
Phase
Phase 3
People taking part
300 people, planned
Started
29 Apr 2026
Expected to end
May 2028
Type of study
Interventional
Treatments tested
  • AXS-14 (esreboxetine)
Record updated
6 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with fibromyalgia who took part in the earlier study AXS-14-FM-301. All participants take AXS-14 (esreboxetine) for up to 52 weeks.

Age
18 Years and older
Sex
All sexes
Disease stage
Fibromyalgia
Earlier treatment
People must have taken part in the study AXS-14-FM-301.

Main reasons for not taking part

  • Not able to follow the study procedures
  • The study doctor judges that joining is not medically appropriate

The registry criteria, word for word

Show all 3 criteriaShow less

Who can take part

  • Participation in AXS-14-FM-301

Who cannot take part

  • Unable to comply with study procedures
  • Medically inappropriate for study participation in the opinion of the Investigator

Where in United States

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

About the trial

What the trial wants to find out

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.

The group in the trial

  • AXS-14 (esreboxetine)Treatment being tested

    Up to 52 weeks.

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

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
An Open-Label Study to Assess the Long-Term Safety and Efficacy of AXS-14 in the Management of Fibromyalgia
Plain-language title
AXS-14 for long-term fibromyalgia care, checked for safetyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
6 November 2026