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Enrolling by invitation Phase 3 Interventional

Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia

ClinicalTrials.gov ID: NCT07637162

Public ClinicalTrials.gov record NCT07637162. 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 Oct 23, 2026, 9:09 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

An Open-Label Study to Assess the Long-Term Safety and Efficacy of AXS-14 in the Management of Fibromyalgia

Brief summary

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

This is a Phase 3, multi-center, 52-week, open-label trial to evaluate the long-term safety and efficacy of AXS-14 in the management of fibromyalgia.

Study identification

NCT ID
NCT07637162
Recruitment status
Enrolling by invitation
Study type
Interventional
Phase
Phase 3
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Enrollment
300 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
Apr 29, 2026 (Actual)
Primary completion
May 2028 (Estimated)
Completion
May 2028 (Estimated)
Last update posted
Oct 13, 2026

2026 – 2028

United States locations

U.S. sites
35
U.S. states
18
U.S. cities
33
Facility City State ZIP Site status
Clinical Research Site Little Rock Arkansas 72211 —
Clinical Research Site Oceanside California 92056 —
Clinical Research Site Redlands California 92374 —
Clinical Research Site Sacramento California 95821 —
Clinical Research Site Santa Ana California 92705 —
Clinical Research Site Cromwell Connecticut 06416 —
Clinical Research Site Hollywood Florida 33021 —
Clinical Research Site Jacksonville Florida 32256 —
Clinical Research Site Lakeland Florida 33803 —
Clinical Research Site Orlando Florida 32801 —
Clinical Research Site Orlando Florida 32832 —
Clinical Research Site Tampa Florida 33634 —
Clinical Research Site The Villages Florida 32159 —
Clinical Research Site Atlanta Georgia 30329 —
Clinical Research Site Norcross Georgia 30092 —
Clinical Research Site Chicago Illinois 60634 —
Clinical Research Site Overland Park Kansas 66209 —
Clinical Research Site Overland Park Kansas 66212 —
Clinical Research Site Louisville Kentucky 40205 —
Clinical Research Site Prairieville Louisiana 70769 —
Clinical Research Site Boston Massachusetts 02131 —
Clinical Research Site Watertown Massachusetts 02472 —
Clinical Research Site Springfield Missouri 65807 —
Clinical Research Site Town and Country Missouri 63017 —
Clinical Research Site Las Vegas Nevada 89102 —
Clinical Research Site Brooklyn New York 11235 —
Clinical Research Site Williamsville New York 14221 —
Clinical Research Site Tulsa Oklahoma 74133 —
Clinical Research Site Duncansville Pennsylvania 16635 —
Clinical Research Site Charleston South Carolina 29407 —
Clinical Research Site Knoxville Tennessee 37909 —
Clinical Research Site Memphis Tennessee 38119 —
Clinical Research Site Austin Texas 78737 —
Clinical Research Site Dallas Texas 75251 —
Clinical Research Site Prosper Texas 75078 —

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 NCT07637162, 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 Oct 13, 2026 · Synced Oct 23, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07637162 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →