NCT07398417

Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design

A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy and Safety of AXS-14 in the Management of Fibromyalgia

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 620 (estimated)
• Sponsor: Axsome Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is a Phase 3, double-blind, placebo-controlled, randomized withdrawal study to assess the efficacy and safety of AXS-14 in the management of fibromyalgia.

Detailed description

This study is a multi-center trial consisting of a 12-week open-label treatment period (OLP), followed by a 12-week double-blind, placebo-controlled, randomized withdrawal period (DBRWP). During the OLP, subjects receive open-label AXS-14. Subjects achieving treatment response will be randomized into the DBRWP in a 1:1 ratio to either continue on AXS-14 or switch to placebo for up to 12 weeks or until a loss of therapeutic response occurs.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DRUG	AXS-14 (Esreboxetine)	AXS-14 tablets taken once daily
DRUG	Placebo	Placebo tablets taken once daily

Timeline

• Start date: 2026-01-14
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2026-02-09
• Last updated: 2026-02-09

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study