Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07398417

Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design

Led by Axsome Therapeutics, Inc. · Updated on 2026-02-09

620

Participants Needed

16

Research Sites

111 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Has a primary diagnosis of fibromyalgia based on the 2016 ACR diagnostic criteria.
  • Male or female, 18 years of age or older.
  • Provides written informed consent to participate in the study before conducting any study procedures.
Not Eligible

You will not qualify if you...

  • Previous participation in a clinical trial with reboxetine or esreboxetine or current treatment with reboxetine for any condition.
  • Unable to comply with study procedures.
  • Medically inappropriate for study participation according to the investigator.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 16 locations

1

Clinical Research Site

Little Rock, Arkansas, United States, 72211

Actively Recruiting

2

Clinical Research Site

Santa Ana, California, United States, 92705

Actively Recruiting

3

Clinical Research Site

Cromwell, Connecticut, United States, 06416

Actively Recruiting

4

Clinical Research Site

Jacksonville, Florida, United States, 32256

Actively Recruiting

5

Clinical Research Site

Orlando, Florida, United States, 32801

Actively Recruiting

6

Clinical Research Site

Tampa, Florida, United States, 33634

Actively Recruiting

7

Clinical Research Site

Atlanta, Georgia, United States, 30329

Actively Recruiting

8

Clinical Research Site

Overland Park, Kansas, United States, 66209

Actively Recruiting

9

Clinical Research Site

Louisville, Kentucky, United States, 40205

Actively Recruiting

10

Clinical Research Site

Prairieville, Louisiana, United States, 70769

Actively Recruiting

11

Clinical Research Site

Springfield, Missouri, United States, 65807

Actively Recruiting

12

Clinical Research Site

Town and Country, Missouri, United States, 63017

Actively Recruiting

13

Clinical Research Site

Tulsa, Oklahoma, United States, 74133

Actively Recruiting

14

Clinical Research Site

Charleston, South Carolina, United States, 29407

Actively Recruiting

15

Clinical Research Site

Memphis, Tennessee, United States, 38119

Actively Recruiting

16

Clinical Research Site

Prosper, Texas, United States, 75078

Actively Recruiting

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Research Team

S

Study Director

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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