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)

NCT ID: NCT05550207

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-31

Study Completion Date

2024-11-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Migraine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AXS-07 (meloxicam-rizatriptan)

Up to 8 weeks

Group Type EXPERIMENTAL

AXS-07 (meloxicam-rizatriptan)

Intervention Type DRUG

AXS-07 tablets, taken orally for the acute treatment of migraine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AXS-07 (meloxicam-rizatriptan)

AXS-07 tablets, taken orally for the acute treatment of migraine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Axsome Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinical Research Site

Colton, California, United States

Site Status

Clinical Research Site

Fullerton, California, United States

Site Status

Clinical Research Site

La Jolla, California, United States

Site Status

Clinical Research Site

Los Angeles, California, United States

Site Status

Clinical Research Site

Sherman Oaks, California, United States

Site Status

Clinical Research Site

Stamford, Connecticut, United States

Site Status

Clinical Research Site

DeLand, Florida, United States

Site Status

Clinical Research Site

Hallandale, Florida, United States

Site Status

Clinical Research Site

Hollywood, Florida, United States

Site Status

Clinical Research Site

Miami, Florida, United States

Site Status

Clinical Research Site

Ormond Beach, Florida, United States

Site Status

Clinical Research Site

Oviedo, Florida, United States

Site Status

Clinical Research Site

Pensacola, Florida, United States

Site Status

Clinical Research Site

Winter Park, Florida, United States

Site Status

Clinical Research Site

Stockbridge, Georgia, United States

Site Status

Clinical Research Site

Avon, Indiana, United States

Site Status

Clinical Research Site

Boston, Massachusetts, United States

Site Status

Clinical Research Site

North Dartmouth, Massachusetts, United States

Site Status

Clinical Research Site

Las Vegas, Nevada, United States

Site Status

Clinical Research Site

Albuquerque, New Mexico, United States

Site Status

Clinical Research Site

The Bronx, New York, United States

Site Status

Clinical Research Site

Williamsville, New York, United States

Site Status

Clinical Research Site

Philadelphia, Pennsylvania, United States

Site Status

Clinical Research Site

Charleston, South Carolina, United States

Site Status

Clinical Research Site

Knoxville, Tennessee, United States

Site Status

Clinical Research Site

Nashville, Tennessee, United States

Site Status

Clinical Research Site

Cypress, Texas, United States

Site Status

Clinical Research Site

Sugar Land, Texas, United States

Site Status

Clinical Research Site

Salt Lake City, Utah, United States

Site Status

Clinical Research Site

Charlottesville, Virginia, United States

Site Status

Clinical Research Site

McLean, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://www.axsome.com

Axsome Therapeutics Website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AXS-07-304

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.