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Recruiting Phase 3 NCT07398417
Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design
Trial Parameters
Condition Fibromyalgia
Sponsor Axsome Therapeutics, Inc.
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 620
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2026-01-14
Completion 2028-03
Interventions
AXS-14 (Esreboxetine)Placebo
Brief 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 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.
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