Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design
Recruiting · NCT07398417 · Interventional (participants receive a specific treatment) · Lead sponsor: Axsome Therapeutics, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
AXS-14 (Esreboxetine)Placebo
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
53 locations listed across 21 US states.
- Clinical Research Site - Glendale, Arizona, United States
- Clinical Research Site - Phoenix, Arizona, United States
- Clinical Research Site - Tucson, Arizona, United States
- Clinical Research Site - Little Rock, Arkansas, United States
- Clinical Research Site - Anaheim, California, United States
- Clinical Research Site - Oceanside, California, United States
- Clinical Research Site - Redlands, California, United States
- Clinical Research Site - Sacramento, California, United States
- Clinical Research Site - Santa Ana, California, United States
- Clinical Research Site - Cromwell, Connecticut, United States
- Clinical Research Site - Hollywood, Florida, United States
- Clinical Research Site - Jacksonville, Florida, United States
- Clinical Research Site - Lakeland, Florida, United States
- Clinical Research Site - Maitland, Florida, United States
- Clinical Research Site - Orlando, Florida, United States
- Clinical Research Site - Orlando, Florida, United States
- Clinical Research Site - Tampa, Florida, United States
- Clinical Research Site - The Villages, Florida, United States
- Clinical Research Site - Atlanta, Georgia, United States
- Clinical Research Site - Atlanta, Georgia, United States
- Clinical Research Site - Marietta, Georgia, United States
- Clinical Research Site - Norcross, Georgia, United States
- Clinical Research Site - Chicago, Illinois, United States
- Clinical Research Site - Tinley Park, Illinois, United States
- Clinical Research Site - Kansas City, Kansas, United States
- Clinical Research Site - Overland Park, Kansas, United States
- Clinical Research Site - Overland Park, Kansas, United States
- Clinical Research Site - Louisville, Kentucky, United States
- Clinical Research Site - Prairieville, Louisiana, United States
- Clinical Research Site - Boston, Massachusetts, United States
- Clinical Research Site - Watertown, Massachusetts, United States
- Clinical Research Site - Hazelwood, Missouri, United States
- Clinical Research Site - Springfield, Missouri, United States
- Clinical Research Site - Town and Country, Missouri, United States
- Clinical Research Site - Las Vegas, Nevada, United States
- Clinical Research Site - Brooklyn, New York, United States
- Clinical Research Site - Hartsdale, New York, United States
- Clinical Research Site - Williamsville, New York, United States
- Houston - High Point, North Carolina, United States
- Clinical Research Site - Huber Heights, Ohio, United States
- Clinical Research Site - Milford, Ohio, United States
- Clinical Research Site - Tulsa, Oklahoma, United States
- Clinical Research Site - Duncansville, Pennsylvania, United States
- Clinical Research Site - Cranston, Rhode Island, United States
- Clinical Research Site - Knoxville, Tennessee, United States
- Clinical Research Site - Memphis, Tennessee, United States
- Clinical Research Site - Austin, Texas, United States
- Clinical Research Site - Austin, Texas, United States
- Clinical Research Site - Dallas, Texas, United States
- Clinical Research Site - Houston, Texas, United States
- Clinical Research Site - Prosper, Texas, United States
- Clinical Research Site - San Antonio, Texas, United States
- Clinical Research Site - The Woodlands, Texas, United States