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Recruiting
NCT07398417
Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design
Conditions: Fibromyalgia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 620
Sponsor: Axsome Therapeutics, Inc.
Location: Clinical Research Site Glendale Arizona
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.
Source: ClinicalTrials.gov (NCT07398417). StuddyBuddy aggregates publicly available trial information.
