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)
Phase 3
Completed
- Conditions
- Migraine
- Interventions
- Drug: AXS-07 (meloxicam-rizatriptan)
- Registration Number
- NCT05550207
- Lead Sponsor
- Axsome Therapeutics, Inc.
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AXS-07 (meloxicam-rizatriptan) AXS-07 (meloxicam-rizatriptan) Up to 8 weeks
- Primary Outcome Measures
Name Time Method Percentage of subjects with headache pain relief 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 Hour 2 following dose administration Absence of the most bothersome symptom, defined at the onset of migraine.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Research Site
🇺🇸McLean, Virginia, United States