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)
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
1 other identifier
interventional
100
1 country
31
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2022
31 active sites
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 Start
First participant enrolled
August 31, 2022
CompletedFirst Submitted
Initial submission to the registry
September 19, 2022
CompletedFirst Posted
Study publicly available on registry
September 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 27, 2024
CompletedDecember 2, 2025
November 1, 2025
2.2 years
September 19, 2022
November 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of subjects with headache pain relief
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
Absence of the most bothersome symptom, defined at the onset of migraine.
Hour 2 following dose administration
Study Arms (1)
AXS-07 (meloxicam-rizatriptan)
EXPERIMENTALUp to 8 weeks
Interventions
AXS-07 tablets, taken orally for the acute treatment of migraine
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Clinical Research Site
Colton, California, 92324, United States
Clinical Research Site
Fullerton, California, 92835, United States
Clinical Research Site
La Jolla, California, 92037, United States
Clinical Research Site
Los Angeles, California, 90067, United States
Clinical Research Site
Sherman Oaks, California, 91403, United States
Clinical Research Site
Stamford, Connecticut, 06905, United States
Clinical Research Site
DeLand, Florida, 32720, United States
Clinical Research Site
Hallandale, Florida, 33009, United States
Clinical Research Site
Hollywood, Florida, 33024, United States
Clinical Research Site
Miami, Florida, 33126, United States
Clinical Research Site
Ormond Beach, Florida, 31274, United States
Clinical Research Site
Oviedo, Florida, 32765, United States
Clinical Research Site
Pensacola, Florida, 32504, United States
Clinical Research Site
Winter Park, Florida, 32789, United States
Clinical Research Site
Stockbridge, Georgia, 30281, United States
Clinical Research Site
Avon, Indiana, 46123, United States
Clinical Research Site
Boston, Massachusetts, 02131, United States
Clinical Research Site
North Dartmouth, Massachusetts, 02747, United States
Clinical Research Site
Las Vegas, Nevada, 89102, United States
Clinical Research Site
Albuquerque, New Mexico, 87102, United States
Clinical Research Site
The Bronx, New York, 10466, United States
Clinical Research Site
Williamsville, New York, 14221, United States
Clinical Research Site
Philadelphia, Pennsylvania, 19114, United States
Clinical Research Site
Charleston, South Carolina, 29406, United States
Clinical Research Site
Knoxville, Tennessee, 37909, United States
Clinical Research Site
Nashville, Tennessee, 37203, United States
Clinical Research Site
Cypress, Texas, 77429, United States
Clinical Research Site
Sugar Land, Texas, 77478, United States
Clinical Research Site
Salt Lake City, Utah, 84107, United States
Clinical Research Site
Charlottesville, Virginia, 22911, United States
Clinical Research Site
McLean, Virginia, 22101, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
September 19, 2022
First Posted
September 22, 2022
Study Start
August 31, 2022
Primary Completion
November 27, 2024
Study Completion
November 27, 2024
Last Updated
December 2, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share