Topiramate is safe and effective in preventing migraine in 12- to 17-year-old patients, according to a report in the journal Pediatrics.

While topiramate is FDA-approved for migraine prophylaxis in adults, the authors explain, there are no approved drugs for migraine prophylaxis in pediatric patients.

Dr. Donald Lewis from Eastern Virginia Medical School, Norfolk, and colleagues evaluated the efficacy and safety of topiramate (50 milligrams/day and 100 milligrams/day) as migraine prophylaxis in 106 patients 12 to 17 years of age.

The higher dose of topiramate significantly reduced the monthly migraine attack rate from an average mean of 4.3 to 1.3 attacks, the authors report, whereas the lower dose did not differ from placebo (attacks reduced from an average of 4.1 to 2.3 in both groups).

In the last 4 weeks of the double-blind phase of the study, more than half the subjects in the 100 milligrams/day topiramate group remained migraine free.

The responder rate was 83 percent for the 100 milligrams/day topiramate group, the researchers note, but only 46 percent for the 50 milligrams/day topiramate group and 45 percent for the placebo group.

Nearly three quarters of the patients in both topiramate groups experienced adverse events, compared with less than half of the patients in the placebo group, with the topiramate groups experiencing more upper respiratory tract infection, paresthesia, and dizziness.

"Safety analyses revealed no unexpected findings," the investigators conclude. "The results of this trial demonstrated that 100 milligrams/day topiramate showed efficacy in the prevention of migraine in pediatric subjects."

SOURCE: Pediatrics, March 2009.