Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Fibromyalgia

In brief

The study is a Phase 3, double-blind, placebo-controlled, randomized withdrawal study to assess the efficacy and safety of AXS-14 in the management of fibromyalgia.

Key facts

Study ID

NCT07398417

Run by

Axsome Therapeutics, Inc.

People needed

620

Starts

2026-01-14

Expected to finish

2028-03-01

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…

• Has a primary diagnosis of fibromyalgia based on the 2016 ACR diagnostic criteria.
• Male or female, ≥18 years of age.
• Provides written informed consent to participate in the study before conducting any study procedures.

You may not qualify if…

• Previous participation in a clinical trial with reboxetine or esreboxetine or currently receiving treatment with reboxetine for any condition.
• Unable to comply with study procedures.
• Medically inappropriate for study participation in the opinion of the investigator.

Where it is running

• Clinical Research Site — Phoenix, Arizona, United States (enrolling)
• Clinical Research Site — Tucson, Arizona, United States (enrolling)
• Clinical Research Site — Little Rock, Arkansas, United States (enrolling)
• Clinical Research Site — Anaheim, California, United States (enrolling)
• Clinical Research Site — Oceanside, California, United States (enrolling)
• Clinical Research Site — Redlands, California, United States (enrolling)
• Clinical Research Site — Sacramento, California, United States (enrolling)
• Clinical Research Site — Santa Ana, California, United States (enrolling)
• Clinical Research Site — Cromwell, Connecticut, United States (enrolling)
• Clinical Research Site — Hollywood, Florida, United States (enrolling)
• Clinical Research Site — Jacksonville, Florida, United States (enrolling)
• Clinical Research Site — Lakeland, Florida, United States (enrolling)
• Clinical Research Site — Maitland, Florida, United States (enrolling)
• Clinical Research Site — Orlando, Florida, United States (enrolling)
• Clinical Research Site — Orlando, Florida, United States (enrolling)
• Clinical Research Site — Tampa, Florida, United States (enrolling)
• Clinical Research Site — The Villages, Florida, United States (enrolling)
• Clinical Research Site — Atlanta, Georgia, United States (enrolling)
• Clinical Research Site — Atlanta, Georgia, United States (enrolling)
• Clinical Research Site — Marietta, Georgia, United States (enrolling)
• Clinical Research Site — Norcross, Georgia, United States (enrolling)
• Clinical Research Site — Chicago, Illinois, United States (enrolling)
• Clinical Research Site — Tinley Park, Illinois, United States (enrolling)
• Clinical Research Site — Overland Park, Kansas, United States (enrolling)
• Clinical Research Site — Glendale, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.