Randomized controlled trial of the CGRP receptor antagonist telcagepant for migraine prevention

摘要: Objective: To evaluate whether the calcitonin gene-related peptide (CGRP) receptor antagonist telcagepant might be effective for migraine prevention. Methods: In this randomized, double-blind, placebo-controlled, multicenter trial (ClinicalTrials.govNCT00797667), patients experiencing 3–14 days during a 4-week baseline were randomized to 140 mg, 280 or placebo twice daily 12 weeks. Efficacy was assessed by mean monthly headache and migraine/probable (headache plus ≥1 associated symptom). Results: The terminated following recommendation from Safety Monitoring Board due hepatotoxicity concerns. At termination, planned 660 had been 656 treated with dose of study medication, 14 completed trial. treatment duration 48–50 days. Thirteen patients, all in groups, an alanine aminotransferase (ALT) elevation ≥3× upper limit normal 7 these also aspartate normal. Two very high symptomatic transaminase elevations that occurred within 2–6 weeks initiation resolved after discontinuation. originally efficacy analysis over not performed limited data at later time points, but there evidence resulted larger reduction than (month 1: mg = −2.9, −3.1, −1.7; p Conclusions: These suggest potential role CGRP antagonism prophylaxis. However, observed do support use administration. Classification evidence: This provides Class II migraine, taken reduces 1.4 per month compared causes 2.5% have serum ALT levels.