Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
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).
- 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
An Open-Label Study to Assess the Long-Term Safety and Efficacy of AXS-14 in the Management of Fibromyalgia
Overview
This is a Phase 3, multi-center, 52-week, open-label trial to evaluate the long-term safety and efficacy of AXS-14 in the management of fibromyalgia.
Detailed description
Eligible subjects will have previously participated in the AXS-14-FM-301 (FORWARD) study. Subjects in this open-label extension trial will receive open-label AXS-14 for up to 52 weeks.
Interventions
- Drug AXS-14 (esreboxetine)
AXS-14 tablets taken twice daily.
Primary outcome measures
- Long-term Safety [Time frame: Up to 52 weeks.]
Eligibility criteria
Inclusion criteria
- Participation in AXS-14-FM-301.
Exclusion criteria
- 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
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 18 centers
- Clinical Research Site — Arkansas City
- Clinical Research Site — Redlands
- Clinical Research Site — Sacramento
- Clinical Research Site — Santa Ana
- Clinical Research Site — Jacksonville
- Clinical Research Site — Orlando
- Clinical Research Site — Tampa
- Clinical Research Site — Atlanta
- … and 10 more centers
Identifiers
NCT: NCT07637162 · AXS-14-FM-302