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)

• Status: Completed
• Trial end date: 2009-08-24
• Target enrollment: 0
• Participant gender: All

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 least one drug combination is superior to telecagepant alone in the treatment of acute migraines.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Acetaminophen; Ibuprofen

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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