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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,594
AXS-07 taken once upon onset of a qualifying migraine.
Meloxicam taken once upon onset of a qualifying migraine.
Rizatriptan taken once upon onset of a qualifying migraine.
Placebo taken once upon onset of a qualifying migraine.
Clinical Research Site
Birmingham, Alabama, United States
Clinical Research Site
Birmingham, Alabama, United States
Clinical Research Site
Mobile, Alabama, United States
Clinical Research Site
Phoenix, Arizona, United States
Clinical Research Site
Tempe, Arizona, United States
Clinical Research Site
Percentage of Subjects Reporting Headache Pain Freedom
Absence of headache pain. AXS-07 vs Placebo.
Time frame: 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.
Time frame: Hour 2 following dose administration
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Little Rock, Arkansas, United States
Clinical Research Site
Canoga Park, California, United States
Clinical Research Site
Colton, California, United States
Clinical Research Site
Culver City, California, United States
Clinical Research Site
Encino, California, United States
...and 75 more locations