What is AXS-14 studying for fibromyalgia?

AXS-14 is being studied to assess its safety and effectiveness in managing fibromyalgia symptoms. This clinical trial aims to understand how well AXS-14 can maintain symptom control compared to a placebo. The study is sponsored by Axsome Therapeutics, Inc.

Who may be eligible for this fibromyalgia clinical trial?

Adults aged 18 years or older diagnosed with fibromyalgia based on 2016 criteria may qualify. Both men and women can participate. People currently treated with reboxetine or esreboxetine or those unable to comply with study procedures may not be eligible. Please review eligibility criteria for more details.

Is there any cost to participate in this fibromyalgia clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses to attend study visits may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID07398417

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

Led by Axsome Therapeutics, Inc. · Updated on 2026-02-09

620

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of AXS-14 esreboxetine in adults with fibromyalgia. This Phase 3 trial is designed to assess how well AXS-14 manages fibromyalgia symptoms through a randomized withdrawal approach. The study is double-blind and placebo-controlled to ensure unbiased results. Participants first enter a 12-week open-label treatment period where everyone receives AXS-14 tablets once daily. Those who respond to treatment during this phase are then randomly assigned in a 11 ratio to either continue taking AXS-14 or switch to placebo for another 12 weeks. This double-blind randomized withdrawal period lasts up to 12 weeks or until the participant loses their therapeutic response. Throughout the study, participants will be monitored for their response to treatment and safety. The main measure is the time from randomization to loss of therapeutic response during the 12-week double-blind period. Participants will provide informed consent and undergo study procedures as required. The total study duration for responders includes up to 24 weeks of treatment and observation.

CONDITIONS

Brief Title

Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Has a primary diagnosis of fibromyalgia based on the 2016 ACR diagnostic criteria.
Male or female, 18 years of age or older.
Provides written informed consent to participate in the study before conducting any study procedures.

You will not qualify if you...

Previous participation in a clinical trial with reboxetine or esreboxetine or currently receiving treatment with reboxetine for any condition.
Unable to comply with study procedures.
Medically inappropriate for study participation in the opinion of the investigator.

Research Team

Study Director

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