Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design
ConditionFibromyalgia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAxsome Therapeutics, Inc.
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- AXS-14 (Esreboxetine)
- Placebo
Treatment groups
620 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov