Home › Trials › NCT07398417

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

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

Phase 3 Interventional Axsome Therapeutics, Inc. · NCT07398417

This Phase 3 study will try AXS-14 (esreboxetine) in adults with fibromyalgia who respond to initial open treatment to see if continuing the drug keeps symptoms controlled better than switching to placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment620 (estimated)
Ages18 Years and up
SexAll
SponsorAxsome Therapeutics, Inc. Industry-sponsored
Locations16 sites (Little Rock, Arkansas and 15 other locations)
Trial IDNCT07398417 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with a primary diagnosis of fibromyalgia by 2016 ACR criteria who can provide informed consent, comply with study procedures, and are not currently receiving reboxetine/esreboxetine are ideal candidates.

Not a fit: Patients who do not respond during the open-label period, those with prior exposure to reboxetine/esreboxetine, or those judged medically inappropriate by investigators are unlikely to benefit from the randomized withdrawal phase.

Why it matters

Potential benefit: If successful, continuing AXS-14 could prolong symptom relief and reduce recurrence of fibromyalgia symptoms in patients who initially respond.

How similar studies have performed: Randomized withdrawal designs are commonly used to test maintenance of benefit, and prior trials of norepinephrine reuptake inhibitors in fibromyalgia have shown mixed results rather than consistent success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Little Rock, Arkansas and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions FibromyalgiaCentral SensitizationAllodyniaHyperalgesiaHypersensitivity to sensory stimuliInhibitor of the norepinephrine transporterEsreboxetineAXS-14
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.