Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design
Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design

NCT07398417

RecruitingPhase 3

Sponsor: Axsome Therapeutics, Inc.

Conditions: Fibromyalgia

Interventions: AXS-14 (Esreboxetine), Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (51)
  • Glendale, Arizona, United States
  • Phoenix, Arizona, United States
  • Tucson, Arizona, United States
  • Little Rock, Arkansas, United States
  • Anaheim, California, United States
  • Oceanside, California, United States
  • Redlands, California, United States
  • Sacramento, California, United States
  • Santa Ana, California, United States
  • Cromwell, Connecticut, United States
  • Hollywood, Florida, United States
  • Jacksonville, Florida, United States
  • Lakeland, Florida, United States
  • Maitland, Florida, United States
  • Orlando, Florida, United States
  • Orlando, Florida, United States
  • Tampa, Florida, United States
  • The Villages, Florida, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Marietta, Georgia, United States
  • Norcross, Georgia, United States
  • Chicago, Illinois, United States
  • Tinley Park, Illinois, United States
  • Overland Park, Kansas, United States
  • Overland Park, Kansas, United States
  • Louisville, Kentucky, United States
  • Prairieville, Louisiana, United States
  • Boston, Massachusetts, United States
  • Watertown, Massachusetts, United States
  • + 21 more on CT.gov