Open-Label Safety Study of AXS-14 in Subjects With Fibrom... | NCT07637162

Studies
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia

NCT07637162

Sponsor

Axsome Therapeutics, Inc.

Status

Enrolling by invitation

Last Update Posted

Jun 9, 2026Actual

Enrollment

300Estimated

Phase

Phase 3

Conditions

Fibromyalgia

Interventions

AXS-14 (esreboxetine)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 29, 2026Actual

Primary Completion Date

May 2028Estimated

Completion Date

May 2028Estimated

First Submitted Date

Jun 4, 2026

First Submission Date that Met QC Criteria

Jun 4, 2026

First Posted Date

Jun 9, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2026

Last Update Posted Date

Jun 9, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Eligible subjects will have previously participated in the AXS-14-FM-301 (FORWARD) study. Subjects in this open-label extension trial will receive open-label AXS-14 for up to 52 weeks.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AXS-14 (esreboxetine)	Experimental	Up to 52 weeks.	Drug: AXS-14 (esreboxetine)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AXS-14 (esreboxetine)	Drug	AXS-14 tablets taken twice daily.	AXS-14 (esreboxetine)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Long-term Safety	Incidence of treatment-emergent adverse events following dosing with AXS-14	Up to 52 weeks.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participation in AXS-14-FM-301.

Exclusion Criteria:

Unable to comply with study procedures.
Medically inappropriate for study participation in the opinion of the Investigator.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Site		Santa Ana	California	92705	United States
Clinical Research Site

Label	URL
Study Recruitment Website	View source
Axsome Therapeutics Website	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005356	Fibromyalgia
D006930	Hyperalgesia

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C541385	esreboxetine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided