Status:
COMPLETED
A Study to Test the Safety and Effectiveness of MK-0974 (Telcagepant) Co-administered With Ibuprofen or Acetaminophen in Patients With Migraines With or Without Aura (MK-0974-046)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Migraine
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will test the safety and how effective telcagepant is when taken with ibuprofen or acetaminophen in participants with migraine with or without aura. The primary study hypothesis is that at ...
Eligibility Criteria
Inclusion
- Must be 18 years of age or older
- History of migraine with or without aura for more than 1 year with 1-8 moderate or severe migraine attacks per month in the 2 months prior to starting in the study
- Willing to stay awake for at least 2 hours after taking study drug
- Able to read, understand and complete questionnaires and diaries
Exclusion
- Breast-feeding, pregnant, or plan to become pregnant during the study
- Not able to tell migraine attack from other headaches
- Older than 50 years of age at migraine onset
- Have more than 15 headache days per month or have taken medication for acute headache on more than 10 days per month in any of the 3 months before starting in the study
- History of gastric or small intestinal surgery
- History of heart attack, stroke, unstable angina, coronary artery bypass surgery or transient ischemic attack in the 3 months before starting in the study
- Currently participating or have participated in a study with in investigational compound or device in the last 30 days
Key Trial Info
Start Date :
December 3 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2009
Estimated Enrollment :
683 Patients enrolled
Trial Details
Trial ID
NCT00758836
Start Date
December 3 2008
End Date
August 24 2009
Last Update
October 22 2018
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