The purpose of this study is to test the effectiveness of an approved drug in the early treatment of migraine...
Date First Received: October 29, 2004
Last Updated: July 5, 2006
Verified by: Merck, October 2005
Clinical Trial Phase: Phase 3 | Start Date: October 2004
Overall Status: Completed
Estimated Enrollment: 510
Brief Summary
Official Title: “A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Examine the Efficacy of Rizatriptan 10 Mg Tablet Administered Early During a Migraine Attack While the Pain is Mild”
Condition Keyword(s):
The purpose of this study is to test the effectiveness of an approved drug in the early treatment of migraine.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Outcome Measures for this Clinical Trial
Primary:
- Percentage of patients who are pain free at 2 hours postdose
- Tolerabilty as measured by subjective adverse experience reporting
Secondary:
- % of pts with 24hr sustained pain freedom
- % of pts pain free @30/45/60/90 mins postdose
- % of pts with associated symptoms at 2hr
- % of pts requiring rescue medication btwn 2&24 hrs
- % of pts with functional disabilty @2 hr
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Six month history of migraine; attacks typically mild when they begin with 1-4 migraine attacks per month.
Exclusion Criteria:
- Heart disease
- High blood pressure
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Merck
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Phoenix Arizona 85020 United States
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Santa Monica California 90404 United States
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Encinitas California 92024 United States
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Irvine California 92618 United States
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Walnut Creek California 94596 United States
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Boulder Colorado 80304 United States
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Stamford Connecticut 06902 United States
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Palm Beach Gardens Florida 33410 United States
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Plantation Florida 33324 United States
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Daytona Beach Florida 32114 United States
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Pembroke Pines Florida 33024 United States
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Hialeah Florida 33013 United States
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Decatur Georgia 30033 United States
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Northbrook Illinois 60062 United States
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Wichita Kansas 67212 United States
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Campbellsville Kentucky 42718 United States
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Bardstown Kentucky 40004 United States
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Louisville Kentucky 40202 United States
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North Dartmouth Massachusetts 02747 United States
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Wellesley Hills Massachusetts 02481-2106 United States
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Ann Arbor Michigan 48104 United States
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Minneapolis Minnesota 55402 United States
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Springfield Missouri 65807 United States
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Edison New Jersey 08817 United States
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Moorestown New Jersey 08057 United States
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Mount Vernon New York 10550 United States
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New York New York 10021 United States
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Amherst New York 14226 United States
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Charlotte North Carolina 28211 United States
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Winston-Salem North Carolina 27103 United States
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Cleveland Ohio 44121 United States
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Westerville Ohio 43081 United States
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Thornville Ohio 43076 United States
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West Chester Ohio 45069 United States
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Cincinnati Ohio 45219 United States
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Oklahoma City Oklahoma 73104 United States
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Portland Oregon 97210 United States
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Eugene Oregon 97401 United States
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Upland Pennsylvania 19013 United States
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Cranston Rhode Island 02920 United States
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Anderson South Carolina 29621 United States
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Austin Texas 78705 United States
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San Antonio Texas 78258 United States
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Ft. Worth Texas 76135 United States
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Salt Lake City Utah 84109 United States
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Charlottesville Virginia 22911 United States
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Spokane Washington 99223 United States
Related Publications
References
Cady R, Martin V, Mauskop A, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Efficacy of Rizatriptan 10 mg administered early in a migraine attack. Headache. 2006 Jun;46(6):914-24.
Additional Information
Information obtained from ClinicalTrials.gov on July 23, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00095004
Study ID Number: 2004_089
ClinicalTrials.gov Identifier: NCT00095004
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
