Clinical Trial

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

Name: Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia — clinical trial record (NCT07637162)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Enrolling by Invitation Phase 3

View on ClinicalTrials.gov →

Summary

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.

Protocol Amendment History 1 change

notable Trial sites expanded: 8 -> 18 locations 2026-07-25

Trial Details

NCT Number	NCT07637162
Lead Sponsor	Axsome Therapeutics, Inc.
Conditions	Fibromyalgia
Enrollment	300 participants
Start Date	2026-04-29
Primary Completion	2028-05 (estimated)
Study Completion	2028-05 (estimated)
Updated on ClinicalTrials.gov	2026-07-24