Multiple Attacks Study to Compare the Efficacy and Safety of MK-0974 With Placebo for Acute Migraine (MK-0974-031)

• Status: Completed
• Trial end date: 2009-03-25
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to assess the safety and efficacy of telcagepant (MK-0974) in acute treatment of multiple migraine attacks with or without aura. Primary hypotheses of this study are that telcagepant is superior to placebo, as measured by the proportion of participants who have pain freedom, pain relief, pain freedom consistency, pain relief consistency, and absence of photophobia, phonophobia, and nausea at 2 hours post-dose.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

Inclusion Criteria:

• History of migraines within the past year

• 1 to 8 moderate or severe migraine attacks per month in the past 2 months that lasted between 4 to 72 hours if untreated

• Use acceptable contraception throughout the study

• Able to complete the study questionnaire(s) and paper diary

• Limit consumption of grapefruit juice to no more than one 8 ounce glass a day

Exclusion Criteria:

• Pregnant or breast-feeding or is expecting to become pregnant during the study

• Difficulty distinguishing his/her migraine attacks from tension or interval headaches

• A history of mostly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours

• More than 15 headache-days per month or has taken medication for acute headache on more than 10 days a month in the past 3 months

• Greater than 50 years old at the age of migraine onset

• Previously taken telcagepant