Original Article Randomized, controlled trial of telcagepant over four migraine attacks

Methods: This study evaluated the calcitonin gene-related peptide (CGRP) receptor antagonist telcagepant (tablet for-mulation) for treatment of a migraine attack and across four attacks. Adults with migraine were randomized, double-blind, to telcagepant 140mg, telcagepant 280mg, or control treatment sequences to treat four moderate-to-severe migraine attacks. Control patients received placebo for three attacks and telcagepant 140mg for one attack. Efficacy for the first attack (Attack 1) and consistency of efficacy over multiple attacks were assessed. For an individual patient, consistent efficacy was defined as 3 successes, and lack of consistent efficacy was defined as 2 failures, in treatment response. A total of 1677 patients treated 1 attack and 1263 treated all four attacks. Results: Based on Attack 1 data, telcagepant 140mg and 280mg were significantly (p<.001) more effective than pla-cebo for 2-hour pain freedom, 2-hour pain relief, 2-hour absence of migraine-associated symptoms (phonophobia, photophobia, nausea), and 2–24 hours sustained pain freedom. The percentage of patients with 2-hour pain freedom consistency and 2-hour pain relief consistency was significantly (p<.001) higher for both telcagepant treatment sequences versus control. Adverse events within 48 hours for telcagepant with an incidence 2 % and twice that of placebo were somnolence (placebo 2.3%, 140mg 5.9%, 280mg 5.7%) and vomiting (placebo 1.4%, 140mg 1.0%, 280mg 2.9%). Conclusion: Telcagepant 140mg and 280mg were effective for treatment of a migraine attack and were more consistently effective than control for intermittent treatment of up to four migraine attacks. Telcagepant was generally well tolerated. (Clinicaltrials.gov; NCT00483704