Fibromyalgia Study with Esreboxetine (AXS-14)

This study is testing a drug called AXS-14 (Esreboxetine) to see if it helps people with fibromyalgia. Researchers want to find out how long AXS-14 can help reduce symptoms before they return. You might be able to join if you are at least 18 years old, have a primary diagnosis of fibromyalgia based on specific criteria, and have not previously taken reboxetine or esreboxetine in a clinical trial. The study is currently unclear on its recruitment status and plans to enroll about 620 participants.

Study design
This is a Phase 3, randomized withdrawal study. It involves an initial open-label period where everyone receives AXS-14, followed by a double-blind period where some continue AXS-14 and others switch to a placebo.
What's involved
You would first take AXS-14 for 12 weeks. If your symptoms improve, you would then be randomly assigned to continue AXS-14 or switch to a placebo for up to another 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
The study measures how long it takes for your symptoms to return, up to 12 weeks after being randomized in the second part of the study.

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NCT07398417

Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design

Recruiting
PHASE3Ages 18+InterventionalTreatment
Axsome Therapeutics, Inc.
~620 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:AXS-14 (Esreboxetine)Placebo

At a glance

Recruiting sites
51 of 51 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time from randomization to loss of therapeutic response
Measured over 12 Weeks
Fibromyalgia
51 sites across 21 states
Florida8
Texas6
California5
Georgia4
Arizona3
Missouri3
New York3
Illinois2

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Eligibility criteria

Inclusion

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

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.
  • Time from randomization to loss of therapeutic response12 Weeks