In the study, three patients treated with telcagepant experienced greater than three-fold elevations in liver enzymes (without accompanying elevations in total bilirubin). All events were clinically asymptomatic, transient and deemed by the investigator to be not drug-related (one patient had a co-occurring musculoskeletal injury, one event occurred two months after the last dosing, and one event occurred in a patient who continued to treat with telcagepant without further enzyme elevations).

Study of telcagepant in acute treatment of multiple migraine attacks

The second Phase III study of telcagepant presented at the International Headache Congress showed that telcagepant was superior to placebo for acute treatment of multiple migraine attacks.

This randomized, double-blind, placebo-controlled trial assessed the consistency of response across multiple migraine attacks. A total of 1,677 adult patients who experienced at least one moderate or severe migraine attack, as defined by the International Headache Society criteria, treated up to four acute migraine attacks with either telcagepant tablets at doses of either 140 mg or 280 mg or placebo. Overall treatment effect was assessed by analyzing pain freedom, pain relief (a reduction to mild or none) and absence of migraine-associated symptoms (nausea and sensitivity to light and sound) two hours after treatment and sustained pain freedom from two to 24 hours after treatment. Both 140 mg and 280 mg doses of telcagepant were significantly more effective than placebo at all four endpoints.

Consistency of treatment effect was defined as at least three successful treatments out of four migraine attacks. When compared to placebo, a significantly greater percentage (p<0.001) of patients treated with either dose of telcagepant (140 mg or 280 mg) experienced consistency in pain freedom at two hours (9.3 percent “ 140 mg, 14.1 percent “ 280 mg, 2.7 percent - placebo) and consistency in pain relief at two hours (41.8 percent “ 140 mg, 46.8 percent “ 280 mg, 22.3 percent - placebo).

In this study, the most common adverse event with an incidence greater than two percent and at least twice that of the placebo group within 14 days of telcagepant treatment was somnolence (6.1 percent “ 140 mg, 5.9 percent “ 280 mg, 2.3 percent “ placebo).

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