Efficacy and Safety of Topiramate in Migraine Prevention: a Dose-ranging, Placebo-controlled, Double-blind, Multicenter Trial*

The antiepileptic agent, topiramate, has been under investigation for prevention of migraine for several years. Results of the first in a series of randomized, controlled, double-blind, multicenter studies show that higher doses of topiramate reduce the number of migraine periods and that this reduction is statistically significant compared with placebo. The mean number of migraine days and the migraine attack frequency were also significantly reduced in patients taking topiramate for 26 weeks. (Adv Stud Med. 2003;3(6C):S565-S568) T opiramate is a monosaccharide derivative, originally developed as part of a hypoglycemic drug program, that was found to have antiepileptic properties in animal models. Currently, it is a broad-spectrum, antiepileptic drug approved for the treatment of various seizure disorders in adults and children. Because antiepileptic drugs have shown efficacy in patients with headache disorder, topiramate has been under investigation during the past several years to determine its potential as a prophylactic treatment for migraine and other headache disorders. Several small pilot trials, as well as one single-center, randomized, controlled trial, indicate that topiramate may be a safe and effective treatment option for migraine patients. The first of 3 multicenter, international, placebocontrolled, double-blind trials on the safety and efficacy of topiramate in migraine prophylaxis has been conducted. Preliminary, 20-week treatment results, including 12 weeks of maintenance treatment, were recently reported. Trial data after 26 weeks of total treatment time with 18 weeks of maintenance have now been collected and are reported here. A total of 213 patients aged 12 to 65 years were randomized. Inclusion criteria included an International Headache Society (IHS) diagnosis of migraine with or without aura persisting for at least 6 months, with a frequency of 2 to 12 migraine periods per month during the month prior to trial entry. Migraine period was defined as time from attack onset to cessation of pain, differing from “migraine day” which is any calendar day during which an attack occurred. For example, an attack beginning at 10 PM PROCEEDINGS