Abstracts

This study compares the cognitive and behavioral effects of topiramate with those of carbamazepine using efficacious doses of each drug when used as monotherapy in children with benign rolandic epilepsy., The study is a multicenter, randomized, observer-blinded, parallel-group clinical trial with topiramate or carbamazepine given as first-line therapy. Topiramate is introduced at 25 mg per day. The target dosages are 50 mg per day in 30 kg[gt] weighted patients and 75 mg or 100 mg per day in 30 kg[lt] weight patients in 4 weeks. Carbamazepine is started at 10 mg/kg per day and the target dosage is 20 mg/kg per day in 4 weeks. The primary outcome measure is the difference between the treatments (topiramate versus carbamazepine) in change of the cognitive and behavioral function from baseline to end point (after 28 weeks of treatment), using a 95% confidence interval approach., For the 22 baseline-to-end point cognitive and the 13 baseline-to-end point behavioral comparisons, one test measuring Verbal Intelligence Quotient yields a statistically significant difference between the treatments (p = 0.019), showing worsening for topiramate and improvement of scores for carbamazepine and one additional test also shows a statistically significant difference, again for a test measuring arithematics (p = 0.043), showing a larger change in the negative direction for topiramate. None of the behavioral tests shows statistically significant differences between the treatments. However, integrated functions, verbal comprehension factor including information, similarities, vocabulary and comprehension as well as attention and concentration including arithmetics, digital span and coding do not show statistically significant differences between the treatments, although those scores are in the negative direction for topiramate., Although the pattern of changes in the negative direction seems consistent with clinical information, the differences found between the treatments are small. An important finding of our study is that the differences between two treatments are compensated in the integrated functions., (Supported by JANSSEN, KOREA LIMITED, a Johnson [amp] Johnson company.)