Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AXS-14 (Esreboxetine), Placebo.
- Who it may be relevant to
- Registry conditions: Fibromyalgia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy and Safety of AXS-14 in the Management of Fibromyalgia
Overview
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.
Detailed description
This study is a multi-center trial consisting of a 12-week open-label treatment period (OLP), followed by a 12-week double-blind, placebo-controlled, randomized withdrawal period (DBRWP). During the OLP, subjects receive open-label AXS-14. Subjects achieving treatment response will be randomized into the DBRWP in a 1:1 ratio to either continue on AXS-14 or switch to placebo for up to 12 weeks or until a loss of therapeutic response occurs.
Interventions
- Drug AXS-14 (Esreboxetine)
AXS-14 tablets taken once daily - Drug Placebo
Placebo tablets taken once daily
Primary outcome measures
- Time from randomization to loss of therapeutic response [Time frame: 12 Weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 51 centers
- Clinical Research Site — Glendale
- Clinical Research Site — Phoenix
- Clinical Research Site — Tucson
- Clinical Research Site — Little Rock
- Clinical Research Site — Anaheim
- Clinical Research Site — Oceanside
- Clinical Research Site — Redlands
- Clinical Research Site — Sacramento
- … and 43 more centers
Identifiers
NCT: NCT07398417 · AXS-14-FM-301