METHODS: This study evaluated the calcitonin gene-related peptide (CGRP) 
receptor antagonist telcagepant (tablet formulation) for treatment of a migraine 
attack and across four attacks. Adults with migraine were randomized, 
double-blind, to telcagepant 140 mg, telcagepant 280 mg, or control treatment 
sequences to treat four moderate-to-severe migraine attacks. Control patients 
received placebo for three attacks and telcagepant 140 mg 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 140 mg and 280 mg were 
significantly (p < .001) more effective than placebo 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%, 140 mg = 5.9%, 
280 mg = 5.7%) and vomiting (placebo = 1.4%, 140 mg = 1.0%, 280 mg = 2.9%).
CONCLUSION: Telcagepant 140 mg and 280 mg 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).