Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design
Purpose
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.
Condition
- Fibromyalgia
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental AXS-14 (esreboxetine) |
- Up to 12 weeks in the open-label period; - Up to 12 weeks in the randomized double-blind period (if applicable) |
|
|
Placebo Comparator Placebo |
• Up to 12 weeks in the randomized double-blind period (if applicable) |
|
Recruiting Locations
Clinical Research Site
Glendale, Arizona 85308
Glendale, Arizona 85308
Clinical Research Site
Phoenix, Arizona 85032
Phoenix, Arizona 85032
Clinical Research Site
Tucson, Arizona 85704
Tucson, Arizona 85704
Clinical Research Site
Little Rock, Arkansas 72211
Little Rock, Arkansas 72211
Clinical Research Site
Anaheim, California 92801
Anaheim, California 92801
Clinical Research Site
Oceanside, California 92056
Oceanside, California 92056
Clinical Research Site
Redlands, California 92374
Redlands, California 92374
Clinical Research Site
Sacramento, California 95821
Sacramento, California 95821
Clinical Research Site
Santa Ana, California 92705
Santa Ana, California 92705
Clinical Research Site
Cromwell, Connecticut 06416
Cromwell, Connecticut 06416
Clinical Research Site
Hollywood, Florida 33021
Hollywood, Florida 33021
Clinical Research Site
Jacksonville, Florida 32256
Jacksonville, Florida 32256
Clinical Research Site
Lakeland, Florida 33803
Lakeland, Florida 33803
Clinical Research Site
Maitland, Florida 32751
Maitland, Florida 32751
Clinical Research Site
Orlando, Florida 32801
Orlando, Florida 32801
Clinical Research Site
Orlando, Florida 32832
Orlando, Florida 32832
Clinical Research Site
Tampa, Florida 33634
Tampa, Florida 33634
Clinical Research Site
The Villages, Florida 32159
The Villages, Florida 32159
Clinical Research Site
Atlanta, Georgia 30328
Atlanta, Georgia 30328
Clinical Research Site
Atlanta, Georgia 30329
Atlanta, Georgia 30329
Clinical Research Site
Marietta, Georgia 30060
Marietta, Georgia 30060
Clinical Research Site
Norcross, Georgia 30092
Norcross, Georgia 30092
Clinical Research Site
Chicago, Illinois 60634
Chicago, Illinois 60634
Clinical Research Site
Tinley Park, Illinois 60477
Tinley Park, Illinois 60477
Clinical Research Site
Overland Park, Kansas 66209
Overland Park, Kansas 66209
Clinical Research Site
Overland Park, Kansas 66210
Overland Park, Kansas 66210
Clinical Research Site
Louisville, Kentucky 40205
Louisville, Kentucky 40205
Clinical Research Site
Prairieville, Louisiana 70769
Prairieville, Louisiana 70769
Clinical Research Site
Boston, Massachusetts 02131
Boston, Massachusetts 02131
Clinical Research Site
Watertown, Massachusetts 02472
Watertown, Massachusetts 02472
Clinical Research Site
Hazelwood, Missouri 63042
Hazelwood, Missouri 63042
Clinical Research Site
Springfield, Missouri 65807
Springfield, Missouri 65807
Clinical Research Site
Town and Country, Missouri 63017
Town and Country, Missouri 63017
Clinical Research Site
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
Clinical Research Site
Brooklyn, New York 11235
Brooklyn, New York 11235
Clinical Research Site
Hartsdale, New York 10530
Hartsdale, New York 10530
Clinical Research Site
Williamsville, New York 14221
Williamsville, New York 14221
Houston
High Point, North Carolina 27260
High Point, North Carolina 27260
Clinical Research Site
Huber Heights, Ohio 45424
Huber Heights, Ohio 45424
Clinical Research Site
Milford, Ohio 45150
Milford, Ohio 45150
Clinical Research Site
Tulsa, Oklahoma 74133
Tulsa, Oklahoma 74133
Clinical Research Site
Duncansville, Pennsylvania 16635
Duncansville, Pennsylvania 16635
Clinical Research Site
Cranston, Rhode Island 02920
Cranston, Rhode Island 02920
Clinical Research Site
Knoxville, Tennessee 37909
Knoxville, Tennessee 37909
Clinical Research Site
Memphis, Tennessee 38119
Memphis, Tennessee 38119
Clinical Research Site
Austin, Texas 78731
Austin, Texas 78731
Clinical Research Site
Austin, Texas 78737
Austin, Texas 78737
Clinical Research Site
Dallas, Texas 75251
Dallas, Texas 75251
Clinical Research Site
Houston, Texas 77089
Houston, Texas 77089
Clinical Research Site
Prosper, Texas 75078
Prosper, Texas 75078
Clinical Research Site
San Antonio, Texas 78240
San Antonio, Texas 78240
More Details
- Status
- Recruiting
- Sponsor
- Axsome Therapeutics, Inc.
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.