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

Phase 3Enrolling By InvitationNCT07637162

Axsome Therapeutics, Inc.300 enrolled

Overview

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.

Eligible subjects will have previously participated in the AXS-14-FM-301 (FORWARD) study. Subjects in this open-label extension trial will receive open-label AXS-14 for up to 52 weeks.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Fibromyalgia

Interventions

AXS-14 (esreboxetine)DRUG

AXS-14 tablets taken twice daily.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participation in AXS-14-FM-301. Exclusion Criteria: * Unable to comply with study procedures. * Medically inappropriate for study participation in the opinion of the Investigator.

Locations (8)

Clinical Research Site

Santa Ana, California, United States

Clinical Research Site

Jacksonville, Florida, United States

Clinical Research Site

Orlando, Florida, United States

Clinical Research Site

Tampa, Florida, United States

Outcomes

Primary Outcomes

Long-term Safety

Incidence of treatment-emergent adverse events following dosing with AXS-14

Time frame: Up to 52 weeks.

Data from ClinicalTrials.gov

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