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

Run by Axsome Therapeutics, Inc. · NCT07637162 · Data updated 2026-11-12

Enrolling by invitation only. This study is not taking new participants. Its registered completion date is 2028-05.

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.

Quick facts

Phase	Phase 3
Study type	Interventional
Ages	18 Years and up
Sex	All
Enrollment	300 (estimated)
Sponsor	Axsome Therapeutics, Inc. Industry-sponsored
Drugs / interventions	AXS-14 (esreboxetine)
Locations	38 sites (United States)
Trial ID	NCT07637162 on ClinicalTrials.gov

What this trial studies

Eligible subjects will have previously participated in the AXS-14-FM-301 (FORWARD) study. Subjects in this open-label extension trial will receive open-label AXS-14 for up to 52 weeks.

Who can join: the full rules

Show full inclusion / exclusion criteria

Inclusion Criteria:

* Participation in AXS-14-FM-301.

Exclusion Criteria:

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

Where it's running

Clinical Research Site
Little Rock, Arkansas, United States
Clinical Research Site
Anaheim, California, United States
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Oceanside, California, United States
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Redlands, California, United States
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Sacramento, California, United States
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Santa Ana, California, United States

Show 32 more locations

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Cromwell, Connecticut, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Lakeland, Florida, United States
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Orlando, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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The Villages, Florida, United States
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Atlanta, Georgia, United States
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Norcross, Georgia, United States
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Chicago, Illinois, United States
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Overland Park, Kansas, United States
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Overland Park, Kansas, United States
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Louisville, Kentucky, United States
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Prairieville, Louisiana, United States
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Boston, Massachusetts, United States
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Watertown, Massachusetts, United States
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Hazelwood, Missouri, United States
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Springfield, Missouri, United States
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Town and Country, Missouri, United States
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Las Vegas, Nevada, United States
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Brooklyn, New York, United States
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Williamsville, New York, United States
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Tulsa, Oklahoma, United States
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Duncansville, Pennsylvania, United States
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Charleston, South Carolina, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Prosper, Texas, United States

How to take part

Review the eligibility criteria above with your treating physician.
Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.

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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.