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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

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

ArmDescriptionAssigned 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)
  • Drug: AXS-14 (Esreboxetine)
    AXS-14 tablets taken once daily
Placebo Comparator
Placebo 		• Up to 12 weeks in the randomized double-blind period (if applicable)
  • Drug: Placebo
    Placebo tablets taken once daily

Recruiting Locations

Clinical Research Site
Little Rock 4119403, Arkansas 4099753 72211

Clinical Research Site
Santa Ana 5392900, California 5332921 92705

Clinical Research Site
Cromwell 4832121, Connecticut 4831725 06416

Clinical Research Site
Jacksonville 4160021, Florida 4155751 32256

Clinical Research Site
Orlando 4167147, Florida 4155751 32801

Clinical Research Site
Tampa 4174757, Florida 4155751 33634

Clinical Research Site
Atlanta 4180439, Georgia 4197000 30329

Clinical Research Site
Overland Park 4276873, Kansas 4273857 66209

Clinical Research Site
Louisville 4299276, Kentucky 6254925 40205

Clinical Research Site
Prairieville 4338012, Louisiana 4331987 70769

Clinical Research Site
Springfield 4409896, Missouri 4398678 65807

Clinical Research Site
Town and Country 4411912, Missouri 4398678 63017

Clinical Research Site
Tulsa 4553433, Oklahoma 4544379 74133

Clinical Research Site
Charleston 4574324, South Carolina 4597040 29407

Clinical Research Site
Memphis 4641239, Tennessee 4662168 38119

Clinical Research Site
Prosper 4720833, Texas 4736286 75078

More Details

Status
Recruiting
Sponsor
Axsome Therapeutics, Inc.

Study Contact

Study Director
212-332-5061
AXS-14-FM-301@axsome.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.