RecruitingPhase 3NCT07398417
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
Sponsor
Axsome Therapeutics, Inc.
Enrollment
620 participants
Start Date
Jan 14, 2026
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- 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 Criteria3
- 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.
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Interventions
DRUGAXS-14 (Esreboxetine)
AXS-14 tablets taken once daily
DRUGPlacebo
Placebo tablets taken once daily
Locations(16)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07398417
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