NCT07398417

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
620

participants targeted

Target at P75+ for phase_3

Timeline
22mo left

Started Jan 2026

Geographic Reach
1 country

16 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Jan 2026Mar 2028

Study Start

First participant enrolled

January 14, 2026

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

2.1 years

First QC Date

February 4, 2026

Last Update Submit

February 4, 2026

Conditions

Fibromyalgia

Keywords

FibromyalgiaCentral SensitizationAllodyniaHyperalgesiaHypersensitivity to sensory stimuliInhibitor of the norepinephrine transporter (NET)EsreboxetineAXS-14AxsomeNorepinephrine reuptake inhibitor

Outcome Measures

Primary Outcomes (1)

  • Time from randomization to loss of therapeutic response

    12 Weeks

Study Arms (2)

AXS-14 (esreboxetine)

EXPERIMENTAL

* Up to 12 weeks in the open-label period; * Up to 12 weeks in the randomized double-blind period (if applicable)

Drug: AXS-14 (Esreboxetine)

Placebo

PLACEBO COMPARATOR

• Up to 12 weeks in the randomized double-blind period (if applicable)

Drug: Placebo

Interventions

AXS-14 (Esreboxetine)DRUG

AXS-14 tablets taken once daily

AXS-14 (esreboxetine)
PlaceboDRUG

Placebo tablets taken once daily

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Clinical Research Site

Little Rock, Arkansas, 72211, United States

RECRUITING

Clinical Research Site

Santa Ana, California, 92705, United States

RECRUITING

Clinical Research Site

Cromwell, Connecticut, 06416, United States

RECRUITING

Clinical Research Site

Jacksonville, Florida, 32256, United States

RECRUITING

Clinical Research Site

Orlando, Florida, 32801, United States

RECRUITING

Clinical Research Site

Tampa, Florida, 33634, United States

RECRUITING

Clinical Research Site

Atlanta, Georgia, 30329, United States

RECRUITING

Clinical Research Site

Overland Park, Kansas, 66209, United States

RECRUITING

Clinical Research Site

Louisville, Kentucky, 40205, United States

RECRUITING

Clinical Research Site

Prairieville, Louisiana, 70769, United States

RECRUITING

Clinical Research Site

Springfield, Missouri, 65807, United States

RECRUITING

Clinical Research Site

Town and Country, Missouri, 63017, United States

RECRUITING

Clinical Research Site

Tulsa, Oklahoma, 74133, United States

RECRUITING

Clinical Research Site

Charleston, South Carolina, 29407, United States

RECRUITING

Clinical Research Site

Memphis, Tennessee, 38119, United States

RECRUITING

Clinical Research Site

Prosper, Texas, 75078, United States

RECRUITING

Related Links

MeSH Terms

Conditions

FibromyalgiaHyperalgesia

Interventions

esreboxetine

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesSomatosensory DisordersSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Director

CONTACT

212-332-5061AXS-14-FM-301@axsome.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2026

First Posted

February 9, 2026

Study Start

January 14, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(16)