Maximizing Outcomes in Treating Acute Migraine

Study Overview
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Brief Summary
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AXS-07 is an oral, investigational medicine consisting of MoSEIC meloxicam and rizatriptan, which is being developed for the acute treatment of migraine with or without aura in adults. AXS-07 tablets are formulated to provide an enhanced rate of absorption of meloxicam. This study is designed to evaluate the efficacy and safety of AXS-07 compared to meloxicam, rizatriptan, and placebo for the treatment of a migraine attack. This is a randomized, double-blind, 4-arm, parallel group, single-dose, placebo-controlled trial. Subjects who successfully complete screening and continue to meet all entry criteria will be randomly assigned to take one dose of either AXS-07, meloxicam, rizatriptan, or placebo upon the occurrence of a qualifying migraine.

Official Title
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MOMENTUM: A Randomized, Double-blind, Single-dose, Placebo-controlled Study to Assess the Efficacy and Safety of AXS-07 (Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults

Conditions
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Migraine

Intervention / Treatment
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* Drug: AXS-07 (MoSEIC meloxicam and rizatriptan)
* Drug: Meloxicam
* Drug: Rizatriptan
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Has an established diagnosis of migraine with or without aura. Has experienced an inadequate response to prior acute treatments. Key Exclusion Criteria: Has previously received any investigational drug or device or investigational therapy within 30 days before Screening. Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AXS-07<br>Taken once upon a qualifying migraine | Drug: AXS-07 (MoSEIC meloxicam and rizatriptan)<br>* AXS-07 taken once upon onset of a qualifying migraine.<br>|
| Active Comparator: Meloxicam<br>Taken once upon a qualifying migraine | Drug: Meloxicam<br>* Meloxicam taken once upon onset of a qualifying migraine.<br>|
| Active Comparator: Rizatriptan<br>Taken once upon a qualifying migraine | Drug: Rizatriptan<br>* Rizatriptan taken once upon onset of a qualifying migraine.<br>|
| Placebo Comparator: Placebo<br>Taken once upon a qualifying migraine | Drug: Placebo<br>* Placebo taken once upon onset of a qualifying migraine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Reporting Headache Pain Freedom | Absence of headache pain. AXS-07 vs Placebo. | Hour 2 following dose administration | 
| Percentage of Subjects With Absence of Most Bothersome Symptom | Absence of most bothersome symptom, defined at the onset of migraine. AXS-07 vs Placebo. | Hour 2 following dose administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, AXS-07, Meloxicam, Rizatriptan, Axsome, Axsome Therapeutics, MoSEIC meloxicam