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Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design

A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy and Safety of AXS-14 in the Management of Fibromyalgia

Who can join

Ages 18 and older · All sexes

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.

About the study

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.

What is being tested

• AXS-14 (Esreboxetine) (drug)
• Placebo (drug)

Sponsor: Axsome Therapeutics, Inc. · Participants: 620 · Started: Jan 14, 2026

Contact the study team

• Study Director · Phone: 212-332-5061

Official record on ClinicalTrials.gov — NCT07398417

Locations in the U.S.

Conditions

• Fibromyalgia

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.