Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1594 participants
INTERVENTIONAL
2019-03-04
2019-12-10
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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AXS-07
Taken once upon a qualifying migraine
AXS-07 (MoSEIC meloxicam and rizatriptan)
AXS-07 taken once upon onset of a qualifying migraine.
Meloxicam
Taken once upon a qualifying migraine
Meloxicam
Meloxicam taken once upon onset of a qualifying migraine.
Rizatriptan
Taken once upon a qualifying migraine
Rizatriptan
Rizatriptan taken once upon onset of a qualifying migraine.
Placebo
Taken once upon a qualifying migraine
Placebo
Placebo taken once upon onset of a qualifying migraine.
Interventions
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AXS-07 (MoSEIC meloxicam and rizatriptan)
AXS-07 taken once upon onset of a qualifying migraine.
Meloxicam
Meloxicam taken once upon onset of a qualifying migraine.
Rizatriptan
Rizatriptan taken once upon onset of a qualifying migraine.
Placebo
Placebo taken once upon onset of a qualifying migraine.
Eligibility Criteria
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Inclusion Criteria
* Has experienced an inadequate response to prior acute treatments.
Exclusion Criteria
* Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
18 Years
65 Years
ALL
No
Sponsors
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Axsome Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Research Site
Birmingham, Alabama, United States
Clinical Research Site
Birmingham, Alabama, United States
Clinical Research Site
Mobile, Alabama, United States
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Phoenix, Arizona, United States
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Tempe, Arizona, United States
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Little Rock, Arkansas, United States
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Canoga Park, California, United States
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Colton, California, United States
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Culver City, California, United States
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Encino, California, United States
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Los Alamitos, California, United States
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Los Angeles, California, United States
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Oceanside, California, United States
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Pomona, California, United States
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Redlands, California, United States
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Riverside, California, United States
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San Diego, California, United States
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Santa Monica, California, United States
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Spring Valley, California, United States
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Walnut Creek, California, United States
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Waterbury, Connecticut, United States
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Clermont, Florida, United States
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DeLand, Florida, United States
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Fernandina Beach, Florida, United States
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Hallandale, Florida, United States
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Hialeah, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Lake City, Florida, United States
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Lake Worth, Florida, United States
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Miami, Florida, United States
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Ocoee, Florida, United States
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Orange City, Florida, United States
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Orlando, Florida, United States
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Ormond Beach, Florida, United States
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South Miami, Florida, United States
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Sunrise, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Stockbridge, Georgia, United States
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Meridian, Idaho, United States
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Evanston, Illinois, United States
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Lenexa, Kansas, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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New Orleans, Louisiana, United States
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Boston, Massachusetts, United States
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North Dartmouth, Massachusetts, United States
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Watertown, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Minneapolis, Minnesota, United States
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Kansas City, Missouri, United States
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Springfield, Missouri, United States
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Las Vegas, Nevada, United States
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Berlin, New Jersey, United States
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Toms River, New Jersey, United States
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Albuquerque, New Mexico, United States
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Endwell, New York, United States
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Manlius, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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The Bronx, New York, United States
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Williamsville, New York, United States
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High Point, North Carolina, United States
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Wilmington, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Dublin, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Salem, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Charlottesville, Virginia, United States
Clinical Research Site
Norfolk, Virginia, United States
Clinical Research Site
Bellevue, Washington, United States
Clinical Research Site
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Axsome Therapeutics Website
Other Identifiers
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AXS-07-301
Identifier Type: -
Identifier Source: org_study_id
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