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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 Sep 8, 2026, 12:18 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 28, 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028
Last update posted
Sep 3, 2026

2026 – 2028

United States locations

U.S. sites
31
U.S. states
17
U.S. cities
29
Facility City State ZIP Site status
Clinical Research Site Little Rock Arkansas 72211
Clinical Research Site Redlands California 92374
Clinical Research Site Sacramento California 95821
Clinical Research Site Santa Ana California 92705
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 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 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 Sep 3, 2026 · Synced Sep 8, 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 protocol, eligibility criteria, and contact information for NCT07637162 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →