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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00483704 |
The purpose of the study is to assess the safety and efficacy of MK0974 in acute treatment of multiple migraine attacks with or without aura.
Condition | Intervention | Phase |
---|---|---|
Migraine |
Drug: MK0974 Drug: Comparator : placebo (unspecified) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group Multiple Attacks Study to Compare the Efficacy and Safety of Oral MK0974 With Placebo for the Acute Treatment of Migraine With or Without Aura |
Estimated Enrollment: | 1800 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
MK0974
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Drug: MK0974
Patients will have up to 6 months to treat 4 migraine attacks. Arm 1: All 4 migraine attacks will be treated with MK0974 140 mg tablets Arm 2: All 4 migraine attacks will be treated with MK0974 280 mg tablets. All patients will take study drug at time of migraine onset.
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2: Experimental
MK0974
|
Drug: MK0974
Patients will have up to 6 months to treat 4 migraine attacks. Arm 1: All 4 migraine attacks will be treated with MK0974 140 mg tablets Arm 2: All 4 migraine attacks will be treated with MK0974 280 mg tablets. All patients will take study drug at time of migraine onset.
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3: Placebo Comparator
MK0974 + Placebo
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Drug: Comparator : placebo (unspecified)
All patients will have 6 months to treat 4 migraine attacks. Arms 3 and 4: 3 migraine attacks will be treated with placebo and 1 migraine attack will be treated with MK0974 140 mg tablets. All patients will take study drug at time of migraine onset.
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4: Placebo Comparator
Placebo + MK0974
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Drug: Comparator : placebo (unspecified)
All patients will have 6 months to treat 4 migraine attacks. Arms 3 and 4: 3 migraine attacks will be treated with placebo and 1 migraine attack will be treated with MK0974 140 mg tablets. All patients will take study drug at time of migraine onset.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Toll Free Number | 1-888-577-8839 |
Study Director: | Medical Monitor | Merck |
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2007_546, MK0974-031 |
Study First Received: | May 15, 2007 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00483704 |
Health Authority: | United States: Food and Drug Administration |
multiple attacks of moderate to severe migraine headaches |
Migraine Disorders Headache Central Nervous System Diseases |
Headache Disorders, Primary Brain Diseases Headache Disorders |
Nervous System Diseases |