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

Enrolling by invitation · Phase 3

Conditions studied: Fibromyalgia

In brief

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.

Key facts

Study ID

NCT07637162

Run by

Axsome Therapeutics, Inc.

People needed

300

Starts

2026-04-29

Expected to finish

2028-05-01

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participation in AXS-14-FM-301.

You may not qualify if…

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

Where it is running

• Clinical Research Site — Arkansas City, Arkansas, United States
• Clinical Research Site — Redlands, California, United States
• Clinical Research Site — Sacramento, California, United States
• Clinical Research Site — Santa Ana, California, United States
• Clinical Research Site — Jacksonville, Florida, United States
• Clinical Research Site — Orlando, Florida, United States
• Clinical Research Site — Tampa, Florida, United States
• Clinical Research Site — Atlanta, Georgia, United States
• Clinical Research Site — Norcross, Georgia, United States
• Clinical Research Site — Chicago, Illinois, United States
• Clinical Research Site — Overland Park, Kansas, United States
• Clinical Research Site — Louisville, Kentucky, United States
• Clinical Research Site — Boston, Massachusetts, United States
• Clinical Research Site — Brooklyn, New York, United States
• Clinical Research Site — Tulsa, Oklahoma, United States
• Clinical Research Site — Charleston, South Carolina, United States
• Clinical Research Site — Knoxville, Tennessee, United States
• Clinical Research Site — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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