Back to List
Topiramate for Migraine Prevention:
A Randomized Controlled Trial
Brandes JL, Saper JR, Diamond M, et al.
Posted: November 2004
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
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
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