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Efficacy and Safety of Topiramate for the
Treatment of Chronic Migraine: A Randomized,
Double-Blind, Placebo-Controlled Trial
Silberstein SD, Lipton RB, Dodick, DW, et al.
Posted: April 2007
Objective: To evaluate the efficacy and safety of topiramate
(100 mg/day) compared with placebo for the treatment of chronic migraine.
Methods: This was a randomized, placebo-controlled, parallel-group,
multicenter study consisting of 16 weeks of double-blind treatment. Subjects aged 18
to 65 years with 15 or more headache days per month, at least half of which were
migraine/migrainous headaches, were randomized 1:1 to either topiramate 100 mg/day
Conclusions: Topiramate treatment at daily doses of approximately 100 mg
resulted in statistically significant improvements compared with placebo in mean monthly
migraine/migrainous and migraine headache days. Topiramate is safe and generally well
tolerated in this group of subjects with chronic migraine, a burdensome condition with
important unmet treatment needs. Safety and tolerability of topiramate were consistent
with experience in previous clinical trials involving the drug.