OBJECTIVE: To evaluate the efficacy of telcagepant in patients with migraine and 
coronary artery disease.
BACKGROUND: Calcitonin gene-related peptide receptor antagonists, such as 
telcagepant, may be useful for acute migraine treatment in patients with 
cardiovascular disease, a population for whom triptans are contraindicated.
METHODS: Randomized, double-blind, two-period (6 weeks per period) crossover 
study in patients with stable coronary artery disease and migraine. Patients 
were randomized 1:1 to either: (1) Period 1: telcagepant (280-mg tablet/300-mg 
capsule), Period 2: acetaminophen (1000-mg); or (2) Period 1: placebo for attack 
1 then acetaminophen for subsequent attacks, Period 2: telcagepant. Patients 
could treat up to 12 migraine attacks per period to assess the tolerability of 
telcagepant. The primary efficacy analysis evaluated telcagepant vs placebo on 
2-hour pain freedom during the first attack of Period 1.
RESULTS: One hundred and sixty-five of the planned 400 patients were enrolled, 
and 114 took at least one dose of treatment. Telcagepant was not statistically 
different from placebo for 2-hour pain freedom (25.0% vs 18.9%, odds ratio = 
1.62 [95% confidence interval: 0.62, 4.25]). The median number of attacks 
treated per period was 3. No cardiovascular thrombotic adverse events occurred 
within 14 days of dosing.
CONCLUSION: The study was underpowered due to enrollment difficulties and did 
not demonstrate a significant efficacy difference between telcagepant and 
placebo for the treatment of a migraine attack in patients with stable coronary 
artery disease. Telcagepant was generally well tolerated for acute intermittent 
migraine treatment in these patients.