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 placebo. This is a randomized, double-blind, single-dose, placebo-controlled trial. Subjects who successfully complete the screening period and continue to meet all entry criteria will be randomly assigned to take one dose of either AXS-07 or placebo upon the earliest onset of migraine pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
302
AXS-07 tablet taken once upon the earliest onset of migraine pain.
Placebo tablet taken once upon the earliest onset of migraine pain.
Clinical Research Site
Birmingham, Alabama, United States
Clinical Research Site
Birmingham, Alabama, United States
Clinical Research Site
Mobile, Alabama, United States
Clinical Research Site
Colton, California, United States
Clinical Research Site
Encino, California, United States
Clinical Research Site
Percentage of Subjects Achieving Headache Pain Freedom at Hour 2
Absence of headache pain at Hour 2
Time frame: Hour 2
Percentage of Subjects With Absence of Most Bothersome Symptom at Hour 2
Absence of Most Bothersome Symptom, defined at the onset of migraine at Hour 2
Time frame: Hour 2
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Los Alamitos, California, United States
Clinical Research Site
Los Angeles, California, United States
Clinical Research Site
Redlands, California, United States
Clinical Research Site
Santa Monica, California, United States
Clinical Research Site
Spring Valley, California, United States
...and 31 more locations