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ClinicalTrials.gov record
Recruiting Phase 3 Interventional

Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design

ClinicalTrials.gov ID: NCT07398417

Public ClinicalTrials.gov record NCT07398417. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 12:19 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy and Safety of AXS-14 in the Management of Fibromyalgia

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07398417
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Enrollment
620 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 13, 2026
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028
Last update posted
Sep 3, 2026

2026 – 2028

United States locations

U.S. sites
53
U.S. states
21
U.S. cities
49
Facility City State ZIP Site status
Clinical Research Site Glendale Arizona 85308 Recruiting
Clinical Research Site Phoenix Arizona 85032 Recruiting
Clinical Research Site Tucson Arizona 85704 Recruiting
Clinical Research Site Little Rock Arkansas 72211 Recruiting
Clinical Research Site Anaheim California 92801 Recruiting
Clinical Research Site Oceanside California 92056 Recruiting
Clinical Research Site Redlands California 92374 Recruiting
Clinical Research Site Sacramento California 95821 Recruiting
Clinical Research Site Santa Ana California 92705 Recruiting
Clinical Research Site Cromwell Connecticut 06416 Recruiting
Clinical Research Site Hollywood Florida 33021 Recruiting
Clinical Research Site Jacksonville Florida 32256 Recruiting
Clinical Research Site Lakeland Florida 33803 Recruiting
Clinical Research Site Maitland Florida 32751 Recruiting
Clinical Research Site Orlando Florida 32801 Recruiting
Clinical Research Site Orlando Florida 32832 Recruiting
Clinical Research Site Tampa Florida 33634 Recruiting
Clinical Research Site The Villages Florida 32159 Recruiting
Clinical Research Site Atlanta Georgia 30328 Recruiting
Clinical Research Site Atlanta Georgia 30329 Recruiting
Clinical Research Site Marietta Georgia 30060 Recruiting
Clinical Research Site Norcross Georgia 30092 Recruiting
Clinical Research Site Chicago Illinois 60634 Recruiting
Clinical Research Site Tinley Park Illinois 60477 Recruiting
Clinical Research Site Kansas City Kansas 66160 Recruiting
Clinical Research Site Overland Park Kansas 66209 Recruiting
Clinical Research Site Overland Park Kansas 66212 Recruiting
Clinical Research Site Louisville Kentucky 40205 Recruiting
Clinical Research Site Prairieville Louisiana 70769 Recruiting
Clinical Research Site Boston Massachusetts 02131 Recruiting
Clinical Research Site Watertown Massachusetts 02472 Recruiting
Clinical Research Site Hazelwood Missouri 63042 Recruiting
Clinical Research Site Springfield Missouri 65807 Recruiting
Clinical Research Site Town and Country Missouri 63017 Recruiting
Clinical Research Site Las Vegas Nevada 89102 Recruiting
Clinical Research Site Brooklyn New York 11235 Recruiting
Clinical Research Site Hartsdale New York 10530 Recruiting
Clinical Research Site Williamsville New York 14221 Recruiting
Houston High Point North Carolina 27260 Recruiting
Clinical Research Site Huber Heights Ohio 45424 Recruiting
Clinical Research Site Milford Ohio 45150 Recruiting
Clinical Research Site Tulsa Oklahoma 74133 Recruiting
Clinical Research Site Duncansville Pennsylvania 16635 Recruiting
Clinical Research Site Cranston Rhode Island 02920 Recruiting
Clinical Research Site Knoxville Tennessee 37909 Recruiting
Clinical Research Site Memphis Tennessee 38119 Recruiting
Clinical Research Site Austin Texas 78731 Recruiting
Clinical Research Site Austin Texas 78737 Recruiting
Clinical Research Site Dallas Texas 75251 Recruiting
Clinical Research Site Houston Texas 77089 Recruiting
Clinical Research Site Prosper Texas 75078 Recruiting
Clinical Research Site San Antonio Texas 78240 Recruiting
Clinical Research Site The Woodlands Texas 77832 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07398417, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 3, 2026 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07398417 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →