Trial intelligence / Profile preview

AXS-14 Open-Label Extension Study in Fibromyalgia

NCT07637162Phase 3

Key facts

Status
Enrolling by invitation
Start
Apr 2026
Primary completion
May 2028
Countries
1
Conditions
fibromyalgia (FM)
01

Overview

Phase 3, open-label, single-arm trial of esreboxetine in fibromyalgia (FM), sponsored by Axsome Therapeutics, Inc. Primary endpoint: Long-term Safety at 52 weeks. Started Apr 2026; status: enrolling by invitation.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • AXS-14 (esreboxetine)

    Up to 52 weeks of open-label AXS-14.

03

Who it enrols

Eligible subjects must have previously participated in the AXS-14-FM-301 (FORWARD) study.

04

Endpoints

Primary

  • Long-term Safety

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