Analysis of Safety and Tolerability Data Obtained from Over 1,500 Patients Receiving Topiramate for Migraine Prevention in Controlled Trials

Objective.  Topiramate is an effective and generally well-tolerated migraine preventive therapy, as shown in three large, randomized, double-blind, placebo-controlled registration trials. Based upon efficacy/tolerability, topiramate 100 mg/day (50 mg BID) is the recommended target dose for most patients with migraine. To further assess the safety and tolerability of topiramate for migraine prevention, we analyzed safety data from 1,580 patients who participated in the three pivotal registration trials or an earlier pilot, randomized, double-blind, placebo-controlled trial. Methods.  The safety population consisted of all patients who took ≥1 dose of study medication during the double-blind …