Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design
Recruiting
Phase 3
Interventional Study
Fibromyalgia
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 620 (estimated)
- Sponsor
- Axsome Therapeutics, Inc. · Industry
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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.
Trial Locations
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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 cl…
Contacts