Initiating Early Control of Migraine Pain and Associated Symptoms
NCT ID: NCT04163185
Last Updated: 2021-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
302 participants
INTERVENTIONAL
2019-10-08
2020-03-23
Brief Summary
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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.
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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 migraine
AXS-07 (MoSEIC meloxicam and rizatriptan)
AXS-07 tablet taken once upon the earliest onset of migraine pain.
Placebo
Taken once upon migraine
Placebo
Placebo tablet taken once upon the earliest onset of migraine pain.
Interventions
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AXS-07 (MoSEIC meloxicam and rizatriptan)
AXS-07 tablet taken once upon the earliest onset of migraine pain.
Placebo
Placebo tablet taken once upon the earliest onset of migraine pain.
Eligibility Criteria
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Inclusion Criteria
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
Clinical Research Site
Colton, California, United States
Clinical Research Site
Encino, California, United States
Clinical Research Site
Los Alamitos, California, United States
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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
Clinical Research Site
Walnut Creek, California, United States
Clinical Research Site
Hallandale, Florida, United States
Clinical Research Site
Jacksonville, Florida, United States
Clinical Research Site
Lake City, Florida, United States
Clinical Research Site
Lake Worth, Florida, United States
Clinical Research Site
Ocoee, Florida, United States
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Orlando, Florida, United States
Clinical Research Site
Ormond Beach, Florida, United States
Clinical Research Site
South Miami, Florida, United States
Clinical Research Site
Sunrise, Florida, United States
Clinical Research Site
Tampa, Florida, United States
Clinical Research Site
Stockbridge, Georgia, United States
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Evanston, Illinois, United States
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Louisville, Kentucky, United States
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Boston, Massachusetts, United States
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Waltham, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Springfield, Missouri, United States
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Albuquerque, New Mexico, United States
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Manlius, 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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Oklahoma City, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
Clinical Research Site
Mt. Pleasant, South Carolina, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
Clinical Research Site
Austin, Texas, United States
Clinical Research Site
Salt Lake City, Utah, United States
Clinical Research Site
Charlottesville, Virginia, United States
Countries
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Related Links
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Axsome Website
Other Identifiers
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AXS-07-303
Identifier Type: -
Identifier Source: org_study_id
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