The Effects on Cognitive Function and Behavioral Problems of Topiramate Compared to Carbamazepine as Monotherapy for Children with Benign Rolandic Epilepsy

Abstract

Summary: Purpose: To evaluate the cognitive and behavioral effects of topiramate (TPM) versus carbamazepine (CBZ) using efficacious doses of each drug as monotherapy for children with benign rolandic epilepsy. Methods: A multicenter, randomized, open-label, observer- blinded, parallel-group clinical trial was conducted. TPM was introduced at a dose of 12.5 mg/day with the minimum target dose of 50 mg/day in patients <30 kg and 75 mg/day in pa- tients >30 kg over 4 weeks. CBZ was started at a dose of 10 mg/kg/day with the minimum target dose of 20 mg/kg/day over 4 weeks. Additional individual escalation was allowed up to a maximum target dose. The primary study end point was change on a neuropsychological test battery after 28 weeks of treatment. Results: Neuropsychological data were available for 88 pa- tients (45 patients for TPM and 43 patients for CBZ). Of the cog- nitive variables measured, arithmetic showed significant worsen- ing in TPM (p = 0.037). An additional test, for maze, also showed a significantly greater improvement for CBZ (p = 0.026). Of be- havioral variables, no significant changes were found but the scores had a negative trend for the TPM. When 30 patients on the minimum target dose for TPM were compared to 40 patients treated with minimum target CBZ, there was no sig- nificant worsening of cognitive and behavioral effects in the TPM. Conclusion: The pattern of neuropsychometric changes with TPM seemed to be slightly worse overall than CBZ. How- ever, outcome with the minimum target dose did not differ significantly in comparisons between the treatment groups. Key Words: Cognitive function—Behavioral problems— Topiramate—Carbamazepine—Benign rolandic epilepsy.