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Topiramate for Migraine Prevention:
A Randomized Controlled Trial
Brandes JL, Saper JR, Diamond M, et al.
Posted: November 2004  
JAMA 2004;25(291):965-973

Context:  Small open-label and controlled trials suggest that the antiepileptic drug topiramate is effective for migraine prevention.

Objective:  To assess the efficacy and safety of topiramate for migraine prevention in a large controlled trial.

Design:   A 26-week, randomized, double-blind placebo-controlled study was conducted during outpatient treatment at 52 North American clinical centers. Patients were aged 12 to 65 years and had a 6-month history of migraine and 3 to 12 migraines a month but no more than 15 headache days a month during a 28-day prospective baseline phase.

Results:  Of 483 patients randomized, 468 provided at least one postbaseline efficacy assessment and comprised the intent-to-treat population. Mean monthly migraine frequency decreased significantly for patients receiving topiramate at 100 mg. per day and at 200 mg. per day, versus placebo. Statistically significant reductions occurred within the first month with topiramate at 100 mg. and 200 mg. per day. The responder rate was significantly greater with topiramate at 50 mg. per day, 100 mg. per day, and 200 mg. per day versus placebo. Reductions in migraine days were significant for the 100 mg. per day and 200 mg. per day groups. Rescue medication use was reduced in the 100 mg. per day and 200 mg. per day groups. Adverse events resulting in discontinuation in the topiramate groups included paresthesia, fatigue, and nausea.

Conclusions:   Topiramate showed significant efficacy in migraine prevention within the first month of treatment, an effect maintained for the duration of the double-blind phase.