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
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Little Rock, Arkansas, United States -
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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
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Cromwell, Connecticut, 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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Norcross, Georgia, United States -
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Prairieville, Louisiana, United States -
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Hazelwood, Missouri, United States -
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Tulsa, Oklahoma, United States -
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Duncansville, Pennsylvania, United States -
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Prosper, Texas, United States
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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.