Safety and Efficacy Study of MK0974 in the Acute Migraine (0974-016)
NCT ID: NCT00432237
Last Updated: 2015-07-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1703 participants
INTERVENTIONAL
2007-03-31
2007-12-31
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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MK0974 50 mg
MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
MK0974 50 mg
MK0974 150 mg
MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
MK0974 150 mg
MK0974 300 mg
MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
MK0974 300 mg
Placebo
Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
Comparator: Placebo
MK0974 50 mg soft gel capsule Placebo; MK0974 150 mg soft gel capsule Placebo; MK0974 300 mg soft gel capsule Placebo.
Interventions
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MK0974 50 mg
MK0974 150 mg
MK0974 300 mg
Comparator: Placebo
MK0974 50 mg soft gel capsule Placebo; MK0974 150 mg soft gel capsule Placebo; MK0974 300 mg soft gel capsule Placebo.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Females of childbearing years must use acceptable contraception throughout trial
Exclusion Criteria
* Patient has history or evidence of uncontrolled diabetes, or Human Immunodeficiency Virus (HIV) disease. Patient has uncontrolled cardiovascular disease
* Patient has major depression, other pain syndromes that might interfere with study assessments, psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
* Patient has a history of gastric or small intestinal surgery or has a disease that causes malabsorption
* Patient has a history of cancer within the last 5 years
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Connor KM, Shapiro RE, Diener HC, Lucas S, Kost J, Fan X, Fei K, Assaid C, Lines C, Ho TW. Randomized, controlled trial of telcagepant for the acute treatment of migraine. Neurology. 2009 Sep 22;73(12):970-7. doi: 10.1212/WNL.0b013e3181b87942.
Other Identifiers
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2006_526
Identifier Type: -
Identifier Source: secondary_id
0974-016
Identifier Type: -
Identifier Source: org_study_id
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