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Topiramate in Migraine Prevention: A Double-Blind, Placebo-Controlled Study

Authors


  • Presented in part at the 52nd Annual Meeting of the American Academy of Neurology, San Diego, Calif, April 29-May 6, 2000 and at Headache World 2000, London, UK, September 3-7, 2000.

Address all correspondence to Ms. Doreen L. Potter, DLP Research and Development, 14A Route 146, Mechanicville, NY 12118.

Abstract

Objective.—To evaluate the efficacy of topiramate in the preventative treatment of episodic migraine.

Background.—Topiramate is a broad-spectrum antiepileptic drug effective for treatment of multiple seizure types in adults and children. Antiepileptic agents have demonstrated efficacy in migraine prevention, and open-label experience from our clinic has suggested that topiramate might be effective for this use. We consequently conducted a single-center, double-blind, placebo-controlled trial to evaluate the efficacy and safety of topiramate for the preventative treatment of migraine.

Methods.—Forty patients, aged 19 to 62 years (mean, 38.2 years), were randomly assigned in a 1:1 ratio to receive topiramate (n = 19; all women) or placebo (n = 21; 20 women, 1 man). Following a prospective baseline phase of 4 weeks, the study drug dose was titrated weekly in 25-mg increments over 8 weeks to 200 mg per day or to the maximum tolerated dose. The titration phase was followed by an 8-week maintenance phase.

Results.—During the entire double-blind phase, topiramate-treated patients experienced a significantly lower 28-day migraine frequency (3.31 ± 1.7 versus 3.83 ± 2.1; P = .002) compared to placebo, irrespective of use of concomitant migraine prevention medications. The mean 28-day migraine frequency was reduced by 36% in patients receiving topiramate as compared with 14% in patients receiving placebo (P = .004). Twenty-six percent of the patients on topiramate and 9.5% of the patients on placebo achieved a 50% reduction in migraine frequency (P > .05). The mean dose of topiramate was 125 mg per day (range, 25 to 200 mg per day). Topiramate was well tolerated; 2 of 19 topiramate-treated patients discontinued treatment due to adverse events. Adverse effects that occurred more frequently in topiramate-treated patients included paresthesia, weight loss, altered taste, anorexia, and memory impairment.

Conclusions.—Preventative therapy with topiramate significantly reduced migraine frequency. Larger multicenter clinical studies may further delineate the role of topiramate in migraine prevention.

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