Open-Label Study of AXS-07 for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor (EMERGE)

November 26, 2025 updated by: Axsome Therapeutics, Inc.

An Open-Label, Multiple-Dose Evaluation of the Efficacy and Safety of AXS-07 (Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor

This is a multicenter, open-label trial to evaluate the efficacy and safety of AXS-07 in subjects with migraine attacks and prior inadequate response to oral CGRP inhibitors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Eligible subjects will receive open-label AXS-07 for up to 8 weeks for at-home treatment of their next 4 migraine attacks.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Colton, California, United States, 92324
        • Clinical Research Site
      • Fullerton, California, United States, 92835
        • Clinical Research Site
      • La Jolla, California, United States, 92037
        • Clinical Research Site
      • Los Angeles, California, United States, 90067
        • Clinical Research Site
      • Sherman Oaks, California, United States, 91403
        • Clinical Research Site
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Clinical Research Site
    • Florida
      • DeLand, Florida, United States, 32720
        • Clinical Research Site
      • Hallandale, Florida, United States, 33009
        • Clinical Research Site
      • Hollywood, Florida, United States, 33024
        • Clinical Research Site
      • Miami, Florida, United States, 33126
        • Clinical Research Site
      • Ormond Beach, Florida, United States, 31274
        • Clinical Research Site
      • Oviedo, Florida, United States, 32765
        • Clinical Research Site
      • Pensacola, Florida, United States, 32504
        • Clinical Research Site
      • Winter Park, Florida, United States, 32789
        • Clinical Research Site
    • Georgia
      • Stockbridge, Georgia, United States, 30281
        • Clinical Research Site
    • Indiana
      • Avon, Indiana, United States, 46123
        • Clinical Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Clinical Research Site
      • North Dartmouth, Massachusetts, United States, 02747
        • Clinical Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Clinical Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Clinical Research Site
    • New York
      • The Bronx, New York, United States, 10466
        • Clinical Research Site
      • Williamsville, New York, United States, 14221
        • Clinical Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
        • Clinical Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Clinical Research Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Clinical Research Site
      • Nashville, Tennessee, United States, 37203
        • Clinical Research Site
    • Texas
      • Cypress, Texas, United States, 77429
        • Clinical Research Site
      • Sugar Land, Texas, United States, 77478
        • Clinical Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Clinical Research Site
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Clinical Research Site
      • McLean, Virginia, United States, 22101
        • Clinical Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has an established diagnosis of migraine with or without aura
  • Has experienced an inadequate response to oral CGRP inhibitors for the acute treatment of migraine

Exclusion Criteria:

  • Pregnant, breastfeeding, or planning to become pregnant during the study
  • Has previously received any investigational drug or device or investigational therapy within 30 days before Screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AXS-07 (meloxicam-rizatriptan)
Up to 8 weeks
Drug: AXS-07 (meloxicam-rizatriptan)
AXS-07 tablets, taken orally for the acute treatment of migraine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of subjects with headache pain relief
Time Frame: Hour 2 following dose administration
Absence of headache pain and without the use of rescue medication.
Hour 2 following dose administration
Percentage of subjects with absence of the Most Bothersome Symptom
Time Frame: Hour 2 following dose administration
Absence of the most bothersome symptom, defined at the onset of migraine.
Hour 2 following dose administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axsome Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2022

Primary Completion (Actual)

November 27, 2024

Study Completion (Actual)

November 27, 2024

Study Registration Dates

First Submitted

September 19, 2022

First Submitted That Met QC Criteria

September 19, 2022

First Posted (Actual)

September 22, 2022

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AXS-07-304

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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