NCT07637162

Brief Summary

This is a Phase 3, multi-center, 52-week, open-label trial to evaluate the long-term safety and efficacy of AXS-14 in the management of fibromyalgia.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
22mo left

Started Apr 2026

Geographic Reach
1 country

8 active sites

Status
enrolling by invitation

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 Progress6%
Apr 2026May 2028

Study Start

First participant enrolled

April 29, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 4, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

June 4, 2026

Last Update Submit

June 4, 2026

Conditions

Fibromyalgia

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Long-term Safety

    Incidence of treatment-emergent adverse events following dosing with AXS-14

    Up to 52 weeks.

Study Arms (1)

AXS-14 (esreboxetine)

EXPERIMENTAL

Up to 52 weeks.

Drug: AXS-14 (esreboxetine)

Interventions

AXS-14 (esreboxetine)DRUG

AXS-14 tablets taken twice daily.

AXS-14 (esreboxetine)

Eligibility Criteria

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

You may qualify if:

  • Participation in AXS-14-FM-301.

You may not qualify if:

  • 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 (8)

Clinical Research Site

Santa Ana, California, 92705, United States

Location

Clinical Research Site

Jacksonville, Florida, 32256, United States

Location

Clinical Research Site

Orlando, Florida, 32801, United States

Location

Clinical Research Site

Tampa, Florida, 33634, United States

Location

Clinical Research Site

Atlanta, Georgia, 30329, United States

Location

Clinical Research Site

Louisville, Kentucky, 40205, United States

Location

Clinical Research Site

Tulsa, Oklahoma, 74133, United States

Location

Clinical Research Site

Charleston, South Carolina, 29407, United States

Location

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2026

First Posted

June 9, 2026

Study Start

April 29, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

June 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(8)