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)

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.

Completed

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research Site, Colton, California, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AXS-07 (meloxicam-rizatriptan)

Drug

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

Primary outcomes

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.
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.

Sponsors and collaborators

Lead sponsor

Axsome Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Sep 22, 2022
Registry last updated: Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed