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Topiramate Shows Promise for Migraine Prevention in Teenagers: Presented at AAN

By Jill Stein

SAN FRANCISCO, CA -- April 29, 2004 -- Topiramate may help stave off migraines in adolescents, researchers reported here on April 27^th at the American Academy of Neurologists 56^th Annual Meeting.

Paul Winner, DO, Director, Palm Beach Headache Center, West Palm Beach, Florida, described the results of a post-hoc analysis performed on efficacy and safety data obtained from patients 12 to 18 years of age who were enrolled in three large randomised, double-blind, placebo-controlled trials of topiramate 50, 100, and 200 mg/day.

The double-blind phase of these trials included titration and maintenance periods. During the titration phase, which lasted up to 8 weeks, the initial dose of topiramate of 25 mg/day was increased in weekly increments of 25 mg/day until patients reached the assigned or maximum tolerated dose, whichever was lower.

The titration phase was followed by an 18-week maintenance phase during which patients were allowed only one dose reduction due to tolerability problems.

All participants had 3 to 12 migraine periods but no more than 15 headache days during the baseline phase. The trial excluded patients with chronic daily headache, defined as headache for 15 or more days per months.

Results in 55 evaluable patients showed that topiramate at a dose of 100 mg/day was associated with decreases in mean monthly migraine frequency, migraine days, and acute medication use. Migraine frequency was decreased by at least 50% in 62% of patients who received topiramate at a dose of 100 mg/day versus 21% of placebo-treated patients.

The100 mg/day dose was associated with a statistically significant reduction in monthly acute medication use (P =.042), and with reductions in monthly migraine frequency and migraine days.

Topiramate was generally well tolerated in this population, with paresthesia, upper respiratory tract infection, and weight loss among the most common treatment-emergent adverse events. The overall incidence of adverse effects was less than that observed in the adult population in these trials.

Dr. Winner emphasised that larger trials are needed to corroborate the findings.

The trial was sponsored by Johnson and Johnson Pharmaceutical Research and Development, Raritan, New Jersey.


[Presentation title: Topiramate for Migraine Prevention in Adolescent Patients. Poster P02.102]

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