NCT05550207CompletedPhase 3
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
Axsome Therapeutics, Inc.1 site in 1 country100 target enrollmentStarted: August 31, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Axsome Therapeutics, Inc.
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Percentage of subjects with headache pain relief
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
AXS-07 (meloxicam-rizatriptan)
Experimental
Up to 8 weeks
Intervention: AXS-07 (meloxicam-rizatriptan) (Drug)
Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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