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Bored Studies
RecruitingPhase 3

Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design

Axsome Therapeutics, Inc. · NCT07398417

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
620
US sites recruiting
53
Study start
January 14, 2026
Record last updated
September 4, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: AXS-14 (Esreboxetine); Placebo

Conditions: Fibromyalgia

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Recruiting US locations

Study contacts (from the official record)

  • Study Director · 212-332-5061 · AXS-14-FM-301@axsome.com
All pain studies in Arizona →
Fibromyalgia Response With Esreboxetine Evaluated Using a… (NCT07398417) | Bored Studies