Fibromyalgia
Conditions
Keywords
Fibromyalgia, Central Sensitization, Allodynia, Hyperalgesia, Hypersensitivity to sensory stimuli, Inhibitor of the norepinephrine transporter (NET), Esreboxetine, AXS-14, Axsome, Norepinephrine reuptake inhibitor
Brief 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.
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
AXS-14 tablets taken once daily
DRUGPlacebo
Placebo tablets taken once daily
Sponsors
Axsome Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from randomization to loss of therapeutic response | 12 Weeks |
Countries
United States
Contacts
CONTACTStudy Director
Outcome results
None listed