Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine
NCT ID: NCT01430442
Last Updated: 2023-02-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
1026 participants
INTERVENTIONAL
2011-10-31
2012-05-31
Brief Summary
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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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Treatment A: Rimegepant, 10 mg
Participants received a single dose (one capsule) of rimegepant 10 milligram (mg) orally and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
Rimegepant
Rimegepant capsules
Placebo
Rimegepant placebo-matching capsules
Treatment B: Rimegepant, 25 mg
Participants received a single dose (one capsule) of rimegepant 25 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
Rimegepant
Rimegepant capsules
Placebo
Rimegepant placebo-matching capsules
Treatment C: Rimegepant, 75 mg
Participants received a single dose (one capsule) of rimegepant 75 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
Rimegepant
Rimegepant capsules
Placebo
Rimegepant placebo-matching capsules
Treatment D: Rimegepant, 150 mg
Participants received a single dose (one capsule) of rimegepant 150 mg orally; and three rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
Rimegepant
Rimegepant capsules
Placebo
Rimegepant placebo-matching capsules
Treatment E: Rimegepant, 300 mg
Participants received a single dose (two 150 mg capsules) of rimegepant 300 mg orally; and two rimegepant placebo-matching capsules, orally, anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
Rimegepant
Rimegepant capsules
Placebo
Rimegepant placebo-matching capsules
Treatment F: Rimegepant, 600 mg
Participants received a single dose (four capsules of 150 mg each) of rimegepant 600 mg orally; anytime within 45 days of randomization, once they experienced a migraine headache of moderate to severe intensity.
Rimegepant
Rimegepant capsules
Placebo
Rimegepant placebo-matching capsules
Treatment P: Rimegepant Placebo-Matching Capsules
Participants received a single dose (4 capsules) of rimegepant placebo-matching capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity.
Placebo
Rimegepant placebo-matching capsules
Treatment G: Sumatriptan 100 mg
Participants received a single dose (one capsule) of rimegepant-matching sumatriptan 100 mg orally and three rimegepant matching placebo capsules orally, anytime within 45 days of randomization once they experienced a migraine headache of moderate to severe intensity.
Placebo
Rimegepant placebo-matching capsules
Sumatriptan
Rimegepant matching sumatriptan and Rimegepant matching placebo capsules
Interventions
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Rimegepant
Rimegepant capsules
Placebo
Rimegepant placebo-matching capsules
Sumatriptan
Rimegepant matching sumatriptan and Rimegepant matching placebo capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Migraine attacks more than 1 year with age of onset prior to 50 years of age
* Migraine attacks, on average, last about 4 - 72 hours if untreated
* No more than 8 attacks of moderate to severe intensity per month within last 3 months
* Patient must be able to distinguish migraine attacks from tension/cluster attacks and must have consistent migraine headaches of at least 2 migraine headaches attacks of moderate to severe intensity in each of the last 3 months
* Less than 15 days of headache (migraine or non-migraine) per month in each of 3 months prior to screening
* Male and female ≥ 18 years and ≤ age 65
* No clinically significant abnormality identified on the medical or laboratory evaluation
Exclusion Criteria
* Patient does not receive migraine relief from triptan migraine treatment
* Medications that may alter the pH of the stomach (acid reducing agents), such as H-2 antagonists, Proton Pump inhibitors (PPI), antacids
* History of ergotamine or triptan intake greater than/equal 10 days per month on a regular basis for greater than 3 months
* History of non-narcotic analgesic intake on greater then/equal 15 days per month for greater than/equal 3 months
18 Years
65 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic Arizona
Scottsdale, Arizona, United States
Clinical Res. Advantage Inc/ Desert Clinical Research Llc
Tempe, Arizona, United States
University Of California, San Francisco
San Francisco, California, United States
California Medical Clinic For Headache
Santa Monica, California, United States
Encompass Clinical Research
Spring Valley, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Radiant Research, Inc.
Denver, Colorado, United States
Miami Research Associates
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Compass Research, Llc
Orlando, Florida, United States
Broward Research Group
Pembroke Pines, Florida, United States
Comprehensive Clinical Development, Inc
St. Petersburg, Florida, United States
Diamond Headache Clinic, Ltd.
Chicago, Illinois, United States
Milford Emergency Associates, Inc.
Milford, Massachusetts, United States
Medvadis Research Corporation
Watertown, Massachusetts, United States
Michigan Head Pain And Neurological Institute
Ann Arbor, Michigan, United States
Clinical Research Institute, Inc.
Minneapolis, Minnesota, United States
The Center For Pharmaceutical Research. Pc
Kansas City, Missouri, United States
Clinvest/ A Division Of Banyan Group, Inc.
Springfield, Missouri, United States
Mercy Health Research
St Louis, Missouri, United States
Regional Clinical Research Inc.
Endwell, New York, United States
Central New York Clinical Research
Manlius, New York, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
Pharmquest
Greensboro, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
Pmg Research Of Winston-Salem
Winston-Salem, North Carolina, United States
Community Research
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Clinical Research Of Philadelphia, Llc
Philadelphia, Pennsylvania, United States
Omega Medical Research
Warwick, Rhode Island, United States
Coastal Carolina Research Center, Inc.
Mt. Pleasant, South Carolina, United States
Clinsearch, Llc
Chattanooga, Tennessee, United States
Premier Research Group Limited
Austin, Texas, United States
Futuresearch Trials Of Neurology
Austin, Texas, United States
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States
J. Lewis Research, Inc
Salt Lake City, Utah, United States
J. Lewis Research, Inc
Salt Lake City, Utah, United States
The Innovative Clinical Research Center
Alexandria, Virginia, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, United States
Swedish Pain And Headache Center
Seattle, Washington, United States
Countries
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References
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Marcus R, Goadsby PJ, Dodick D, Stock D, Manos G, Fischer TZ. BMS-927711 for the acute treatment of migraine: a double-blind, randomized, placebo controlled, dose-ranging trial. Cephalalgia. 2014 Feb;34(2):114-25. doi: 10.1177/0333102413500727. Epub 2013 Aug 21.
Other Identifiers
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CN170-003
Identifier Type: -
Identifier Source: org_study_id
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