Keeping fibromyalgia symptoms controlled with AXS-14 (esreboxetine) after an initial response

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, multicenter trial uses a randomized withdrawal design to test whether continued AXS-14 maintains symptom control in adults with fibromyalgia. All participants receive open-label AXS-14 for 12 weeks, and those who meet response criteria are randomized 1:1 to continue AXS-14 or switch to placebo for up to 12 weeks under double-blind conditions. Participants are followed until loss of therapeutic response or the end of the double-blind period, with efficacy and safety monitored throughout. The design enriches the randomized cohort with initial responders to directly measure durability of effect.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

• Clinical Research Site
  Glendale, Arizona, United States Recruiting
• Clinical Research Site
  Phoenix, Arizona, United States Recruiting
• Clinical Research Site
  Tucson, Arizona, United States Recruiting
• Clinical Research Site
  Little Rock, Arkansas, United States Recruiting
• Clinical Research Site
  Anaheim, California, United States Recruiting
• Clinical Research Site
  Oceanside, California, United States Recruiting

+7 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Director
• Email: AXS-14-FM-301@axsome.com
• Phone: 212-332-5061

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How to take part

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