1. Industry-sponsored, randomized, double-blind, placebo-controlled study of 162 children at 17 non-academic clinics.
2. Patients were 6-15 years old with 3-10 migraines/month for 3 months before screening and during 4 week baseline phase.
3. Patients were excluded for cluster headache, chronic migraine, >15 migraines in the 4 week baseline phase, overused analgesics/abortives, had previously failed topiramate or any 2 prophylactic medications, or had a history of nephrolithiasis.
4. Headache diaries were used to track frequency, severity, duration, associated symptoms and use of analgesics/abortives.
5. Symptoms were assessed during a 4 week baseline phase, followed by an 8 week titration phase (up to 2-3mg/kg/d divided BID, or maximum dose of 200mg/day), and a 12 week maintenance phase. Average maintenance dose was 2mg/kg/d.
6. Analyses were performed on the intent-to-treat population (n=157) and the per-protocol population (n=126, patients who completed study without major protocol violations).
7. For the primary endpoint, reduction in number of migraine days per month during the titration and maintenance phases (for ITT group), there was no significant difference between groups (2.6 days/month for topiramate vs. 2 days/month for placebo; p=0.061). However, there was a significant difference for the per-protocol population (2.8 days/month for topiramate, 2.2 days/month for placebo; p=0.033).
8. During the last 28 days of treatment for the ITT population, there was a significant difference in the reduction of migraine days/month (3.1 days/month for topiramate, 2.4 days/month for placebo; p=0.023).