Abstracts

To evaluate the efficacy and tolerability of low dose topiramate (TPM) as compared with carbamazepine (CBZ) especially in neuro-psychological side effects including cognitive function in children with benign rolandic epilepsy (BRE). Open-label, multi-center, randomized clinical trial was done in 71 children (36 males and 35 females) with BRE, aged 5-15 years, for 28 weeks of treatment with TPM(n=40) with low dose (1-2 mg/Kg/day) or CBZ(n=31) in usual doses (10-20 mg/Kg/day). All patients were categorized in BRE with acceptable indication for medication, having frequent, daytime, prolonged, and/or major secondary generalized convulsive seizures. The study included a baseline phase followed by titration and maintenance phases. Psychological testing was performed before the titration, and repeated at the end of maintenance phase. Seizure outcome, neuro-cognitive side effects were compared between low dose TPM and CBZ groups, using a 95% confidence interval approach. Analyses of variances showed no significant difference between TPM and CBZ (Table 1). [table1] There was no significant difference between low dose TPM and CBZ in seizure control, outcome of psychological tests and global assessment. Low dose TPM monotherapy can be substituted in treating BRE with expecting high efficacy and tolerability. (Supported by Janssen Korea Co)