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)

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified October 2025 by Axsome Therapeutics, Inc.
Sponsor
Axsome Therapeutics, Inc.
Information Provided by (Responsible Party)
Axsome Therapeutics, Inc.
Clinicaltrials.gov Identifier
NCT05550207
Other Study ID Numbers:
AXS-07-304
First Submitted
September 18, 2022
First Posted
September 21, 2022
Last Update Posted
December 1, 2025
Last Verified
October 2025

ClinicalTrials.gov processed this data on November 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

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

Condition or DiseaseIntervention/Treatment
Migraine
Drug: AXS-07 (meloxicam-rizatriptan)

Study Design

Study TypeInterventional
Actual Enrollment100 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleAn 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
Study Start DateAugust 30, 2022
Actual Primary Completion DateNovember 26, 2024
Actual Study Completion DateNovember 26, 2024

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures
  1. Percentage of subjects with headache pain relief
    Absence of headache pain and without the use of rescue medication.
  2. Percentage of subjects with absence of the Most Bothersome Symptom
    Absence of the most bothersome symptom, defined at the onset of migraine.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

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