Telcagepant (MK-0974) Treatment of Migraine in Participants With Stable Vascular Disease (MK-0974-034)
Migraine Disorders, Heart Disease, Cerebrovascular Accident
About this trial
This is an interventional treatment trial for Migraine Disorders
Eligibility Criteria
Inclusion Criteria:
- Stable coronary artery disease for 3 months or more
- 18 years of age or older with a history of migraine with or without aura
- Must use acceptable contraception throughout the study
Exclusion Criteria:
- Pregnant, breast-feeding, or planning to become pregnant during this study
- 50 years of age or older when migraines began
- Other pain syndromes that might interfere with study assessments, uncontrolled psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
- History of gastric, or small intestinal surgery, or has a disease that causes malabsorption
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Telcagepant 300 mg→Acetaminophen/Paracetamol 1000 mg
Placebo and APAP 1000 mg→Telcagepant 300 mg
Participants receive up to 12 doses of telcagepant (280 mg tablet/capsule 300 mg), orally, and placebo to acetaminophen/paracetamol (APAP) (2- 500 mg dry filled capsules), orally, for up to 12 migraine attacks in Period 1 (6 weeks). Participants receive APAP and placebo to telcagepant for up to 12 doses, for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned.
Participants receive 1 dose of placebo to APAP and placebo to telcagepant for the first migraine attack and then up to 11 doses of APAP and placebo to telcagepant for up to 11 migraine attacks in Period 1 (6 weeks). Participants receive up to 12 doses of telcagepant and placebo to APAP for up to 12 migraine attacks in Period 2 (6 weeks). The participant may take a blinded optional second dose of study medication or their own rescue medication if 2 hours after initial treatment, the participant still has a moderate or severe migraine headache or if the headache has returned.