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Topiramate in Migraine Prevention
Results of a Large Controlled Trial
Stephen D. Silberstein, MD;
Walter Neto, MD;
Jennifer Schmitt, MS;
David Jacobs, MD; for the MIGR-001 Study Group
Arch Neurol. 2004;61:490-495.
Background Open-label trials and small controlled studies report topiramate's efficacy in migraine prevention.
Objective To assess the efficacy and safety of topiramate as a migraine-preventive therapy.
Design A 26-week, randomized, double-blind, placebo-controlled study.
Setting Outpatient treatment at 49 US clinical centers.
Patients Patients were aged 12 to 65 years, had a 6-month International Headache Society migraine history, and experienced 3 to 12 migraines per month, but had 15 or fewer headache days per month during the 28-day baseline period.
Interventions Participants were randomized to placebo or topiramate, 50, 100, or 200 mg/d, titrated by 25 mg/wk to the assigned dose or as tolerated in 8 weeks; maintenance therapy continued for 18 weeks.
Main Outcome Measures The primary efficacy assessment was a reduction in mean monthly migraine frequency across the 6-month treatment phase. Secondary end points were responder rate, time to onset of action, mean change in migraine days per month, and mean change in rescue medication days per month.
Results Four hundred eighty-seven patients were randomized, and 469 composed the intent-to-treat population. The mean ± SD monthly migraine frequency decreased significantly for the 100-mg/d group (from 5.4 ± 2.2 to 3.3 ± 2.9; P <.001) and the 200-mg/d group (from 5.6 ± 2.6 to 3.3 ± 2.9; P <.001) vs the placebo group (from 5.6 ± 2.3 to 4.6 ± 3.0); improvements occurred within the first treatment month. Significantly more topiramate-treated patients (50 mg/d, 35.9% [P = .04]; 100 mg/d, 54.0% [P <.001]; and 200 mg/d, 52.3% [P <.001]) exhibited a 50% or more reduction in monthly migraine frequency than placebo-treated patients (22.6%). Adverse events included paresthesia, fatigue, nausea, anorexia, and taste per version.
Conclusion Topiramate, 100 or 200 mg/d, was effective as a preventive therapy for patients with migraine.
From the Jefferson Headache Center, Philadelphia, Pa (Dr Silberstein); and Johnson & Johnson Pharmaceutical Research and Development, LLC, Raritan, NJ (Drs Neto and Jacobs and Ms Schmitt). Dr Silberstein is on the advisory panel of, speakers bureau of, or serves as a consultant for Abbott Laboratories, Allergan, Inc, AstraZeneca, Elan Pharmaceutical Research Corp, Eli Lilly, Ortho-McNeil Pharmaceutical, Merck & Co, and GlaxoSmithKline; receives research support from Allergan, Inc, AstraZeneca, Eli Lilly, GlaxoSmithKline, Janssen Pharmaceutica, Merck & Co, Ortho-McNeil Pharmaceutical, Pfizer, Inc, UCB Pharma, and Vernalis; and has received educational grants from Abbott Laboratories, Allergan, Inc, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Merck & Co, Ortho-McNeil Pharmaceutical, and Parke-Davis. Drs Neto and Jacobs and Ms Schmitt hold shares in Johnson & Johnson Pharmaceutical Research and Development, LLC, a subsidiary of Johnson & Johnson Corporation.
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