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Abstract
Many of the drugs available for the prophylaxis of migraine never underwent rigorous placebo-controlled trials, and the effective drugs have side effects that are problematic in daily practice. Three double-blind studies involving more than 1500 patients (the largest clinical development program ever undertaken for migraine prophylaxis) consistently found topiramate, at doses of 100 and 200 mg/day, to be superior to placebo in migraine prophylaxis. Topiramate has demonstrated efficacy in reducing the frequency of migraines, producing a statistically significant effect at 1 month and maintaining effectiveness over more than 6 months. It is not associated with the side effects that may cause patients to stop taking other prophylactic medications.