Topiramate for Migraine Prevention in Adolescents: A Pooled Analysis of Efficacy and Safety

Authors

  • Paul Winner DO,

  • Astrid Gendolla MD,

  • Catherine Stayer MD, PhD,

  • Steven Wang PhD,

  • Eric Yuen MD,

  • Wendy P. Battisti PhD,

  • Jeffrey S. Nye MD, PhD


  • From the Palm Beach Headache Center, West Palm Beach, FL, USA (Dr. Winner); Department of Neurology, University of Essen, Essen, Germany (Dr. Gendolla); and Johnson & Johnson Pharmaceutical Research and Development, LLC, Raritan, NJ, USA (Drs. Stayer, Wang, Yuen, Battisti, Nye).

Address all correspondence to Dr. Wendy Battisti, Johnson & Johnson Pharmaceutical Research and Development, LLC.—Scientific and Medical Publications, 1125 Trenton-Harbourton Road, Titusville, NJ 08560.

Abstract

Objective.—To characterize the efficacy and safety of topiramate for migraine prevention in adolescents from 3 randomized, 26-week, double-blind, placebo-controlled trials.

Background.—Limited information is available regarding the efficacy and safety of prophylactic medications for treatment of adolescent migraine, a significant health problem. In studies that included adults and children, topiramate 100 and 200 mg/day were effective and generally well-tolerated in the prevention of migraine headache.

Methods.—We performed a post hoc subset analysis of the efficacy and safety data from the 51 patients, ages 12–17 years, enrolled in 3 pivotal trials of topiramate for migraine prophylaxis.

Results.—Daily treatment with topiramate 50, 100, and 200 mg for 26 weeks reduced monthly migraine frequency from baseline 46% (P= .07), 63% (P= .02), and 65% (P= .04), respectively, compared with placebo (16%). Similarly, topiramate reduced both the monthly mean number of migraine days (1, 4, and 5 days for topiramate 50, 100, and 200 mg/day, respectively, vs 1 day for placebo) and percentage of days during which acute migraine medications were administered (59%, 54%, and 67% for topiramate 50, 100, and 200 mg/day, respectively, vs 42% for placebo), although the treatment differences did not reach nominal statistical significance. Topiramate 200 mg/day did not appear to offer greater efficacy than 100 mg/day. Treatment was generally well-tolerated, although adverse events were most frequent in the 200 mg/day dose group.

Conclusions.—This post hoc subset analysis suggests that topiramate 100 and 200 mg/day, and possibly 50 mg/day, administered prophylactically for 26 weeks may reduce migraine in adolescents.

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