RecruitingPhase 3

Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design

United States620 participantsStarted 2026-01-14

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Time from randomization to loss of therapeutic response

Timeframe: 12 Weeks

Trial details

NCT IDNCT07398417

SponsorAxsome Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-03

Contact for this trial

Study Director

212-332-5061 AXS-14-FM-301@axsome.com

View on ClinicalTrials.gov More Fibromyalgia trials