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
Little Rock 4119403, Arkansas 4099753 72211
Little Rock 4119403, Arkansas 4099753 72211
Clinical Research Site
Santa Ana 5392900, California 5332921 92705
Santa Ana 5392900, California 5332921 92705
Clinical Research Site
Cromwell 4832121, Connecticut 4831725 06416
Cromwell 4832121, Connecticut 4831725 06416
Clinical Research Site
Jacksonville 4160021, Florida 4155751 32256
Jacksonville 4160021, Florida 4155751 32256
Clinical Research Site
Orlando 4167147, Florida 4155751 32801
Orlando 4167147, Florida 4155751 32801
Clinical Research Site
Tampa 4174757, Florida 4155751 33634
Tampa 4174757, Florida 4155751 33634
Clinical Research Site
Atlanta 4180439, Georgia 4197000 30329
Atlanta 4180439, Georgia 4197000 30329
Clinical Research Site
Overland Park 4276873, Kansas 4273857 66209
Overland Park 4276873, Kansas 4273857 66209
Clinical Research Site
Louisville 4299276, Kentucky 6254925 40205
Louisville 4299276, Kentucky 6254925 40205
Clinical Research Site
Prairieville 4338012, Louisiana 4331987 70769
Prairieville 4338012, Louisiana 4331987 70769
Clinical Research Site
Springfield 4409896, Missouri 4398678 65807
Springfield 4409896, Missouri 4398678 65807
Clinical Research Site
Town and Country 4411912, Missouri 4398678 63017
Town and Country 4411912, Missouri 4398678 63017
Clinical Research Site
Tulsa 4553433, Oklahoma 4544379 74133
Tulsa 4553433, Oklahoma 4544379 74133
Clinical Research Site
Charleston 4574324, South Carolina 4597040 29407
Charleston 4574324, South Carolina 4597040 29407
Clinical Research Site
Memphis 4641239, Tennessee 4662168 38119
Memphis 4641239, Tennessee 4662168 38119
Clinical Research Site
Prosper 4720833, Texas 4736286 75078
Prosper 4720833, Texas 4736286 75078
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.