« Back

Topiramate reduces migraine frequency in adolescents, trial data indicate

Wednesday, March 18 2009 | Comments

---

What's This? Topiramate 100 mg/day is efficacious and well-tolerated as migraine prophylaxis for adolescents, according to findings from a randomized controlled trial.

Researchers randomized 106 participants aged 12 to 17 years with migraine to receive topiramate 50 mg/d, topiramate 100 mg/d, or placebo for 16 weeks. The primary efficacy measure was the percent reduction in the monthly migraine attack rate during the last 12 weeks of treatment (ie, the maintenance phase of double-blind treatment) compared with a 4-week baseline period. The primary analysis used the "48-hour rule," which defined all recurrences of migraine symptoms within 48 hours of onset as a single migraine episode.

The median percent reduction in the monthly migraine attack rate was 72.2% with topiramate 100 mg/d versus 44.4% with placebo (P=.016). The difference between topiramate 50 mg/d (median reduction, 44.6%) and placebo was not significant.

In a secondary analysis, the researchers evaluated the percent reduction in the monthly migraine attack rate during the last 4 weeks of treatment. The median reduction from baseline was 61.4% with placebo, 65.5% with topiramate 50 mg/d and 100% with topiramate 100 mg/d (P=.015 vs placebo), showing that at least half of those who received topiramate 100 mg/d were migraine-free during the final month of treatment.

In addition, 83% of the adolescents randomized to receive topiramate 100 mg/d showed a response to treatment (defined as a reduction of >=50% in the monthly migraine attack rate), compared with 45% of the placebo group (P=.002). The difference between placebo and topiramate 50 mg/d (responder rate, 46%) was not significant. Responder rates were consistently higher with topiramate 100 mg/d regardless of how a response to treatment was defined (>=50%, >=75%, or 100% reduction), the investigators noted.

Other secondary endpoints also supported the primary analysis, including the percent reduction in monthly migraine days, the percent reduction in monthly headache days, and the percent reduction in the monthly migraine attack rate using a "24-hour rule" rather than the 48-hour rule. For all efficacy endpoints, a greater treatment effect was observed when the last 4 weeks were compared with baseline rather than the last 12 weeks.

The safety profile of topiramate was consistent with results of trials evaluating topiramate for migraine prophylaxis in adults and trials evaluating topiramate as a treatment for pediatric epilepsy. Topiramate is typically prescribed at a dosage of 100 mg/d for adults with migraine and at higher dosages for children with epilepsy, the authors noted.

Overall, 83% of the 50 mg/d group, 86% of the 100 mg/d group, and 79% of the placebo group completed double-blind treatment; 74%, 74%, and 48%, respectively, reported >=1 treatment-emergent adverse event. Four participants experienced a serious adverse event, including 2 subjects who were not included in randomization and 2 subjects in the topiramate 100 mg/d group (1 case of back pain and 1 case of injury); the latter events did not lead to discontinuation of treatment and were deemed by the investigators to have an uncertain relation to treatment. On average, weight decreased with topiramate (mean change of 0.1% with 50 mg/d and 0.6% with 100 mg/d) and increased with placebo (1.7%). (Lewis D, et al. Pediatrics 2009;123:924-934.)

This study was funded by Ortho-McNeil-Janssen Pharmaceuticals Inc.

This information concerns a use that has not been approved by the Food and Drug Administration.

Print  |  E-mail