Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
676 participants
INTERVENTIONAL
2008-07-31
2009-01-31
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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1
MK3207- 2.5 mg
MK3207- 2.5 mg
Arm 1: MK3207 2.5 mg taken after migraine onset.
2
MK3207- 5 mg
MK3207- 5 mg
Arm 2: MK3207 5 mg taken after migraine onset.
3
MK3207- 10 mg
MK3207- 10 mg
Arm 3: MK3207 10 mg taken after migraine onset.
4
MK3207- 20 mg
MK3207- 20 mg
Arm 4: MK3207 20 mg taken after migraine onset.
5
MK3207- 50 mg
MK3207- 50 mg
Arm 5: MK3207 50 mg taken after migraine onset.
6
MK3207- 100 mg
MK3207- 100 mg
Arm 6: MK3207 100 mg taken after migraine onset.
7
Placebo
Comparator: placebo (unspecified)
Placebo taken after migraine onset.
Interventions
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MK3207- 2.5 mg
Arm 1: MK3207 2.5 mg taken after migraine onset.
MK3207- 5 mg
Arm 2: MK3207 5 mg taken after migraine onset.
MK3207- 10 mg
Arm 3: MK3207 10 mg taken after migraine onset.
MK3207- 20 mg
Arm 4: MK3207 20 mg taken after migraine onset.
MK3207- 50 mg
Arm 5: MK3207 50 mg taken after migraine onset.
MK3207- 100 mg
Arm 6: MK3207 100 mg taken after migraine onset.
Comparator: placebo (unspecified)
Placebo taken after migraine onset.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 1+ year history of migraine that typically last from 4 to 72 hours if untreated
* Had from 2 to 8 moderate or severe migraine attacks per month in the last 2 months
* Not pregnant or planning to become pregnant in next 6 months
Exclusion Criteria
* Cannot distinguish migraine attacks from tension type headaches
* Migraines are mild or resolve without medication in less than 2 hours
* More than 15 headache-days per month or have taken medication on more than 10 days per month in the last 3 months
* Basilar type or hemiplegic migraine headaches
* More than 50 years old when migraines began
* History of cardiovascular disorder within last 6 months
18 Years
65 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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Hewitt DJ, Aurora SK, Dodick DW, Goadsby PJ, Ge YJ, Bachman R, Taraborelli D, Fan X, Assaid C, Lines C, Ho TW. Randomized controlled trial of the CGRP receptor antagonist MK-3207 in the acute treatment of migraine. Cephalalgia. 2011 Apr;31(6):712-22. doi: 10.1177/0333102411398399. Epub 2011 Mar 7.
Other Identifiers
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2008_536
Identifier Type: -
Identifier Source: secondary_id
3207-005
Identifier Type: -
Identifier Source: org_study_id
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