Abstracts

Rationale: Despite the rising concern about the effects of antiepileptic drugs (AEDs) on neurodevelopment, there are few controlled studies examining the cognitive effects of newer AEDs in children. Lamotrigine (LMT) does not affect cognition in healthy adult volunteers or adult patients with epilepsy, but its effect on cognition in children is uncertain. Hence, we have compared the effects of LMT and carbamazepine (CBZ) on cognition and behavior in children with partial epilepsy. Methods: A multicenter, randomized, open-label, observer-blinded, parallel-group clinical trial was conducted in children with partial seizures. LMT or CBZ was introduced as a monotherapy to previously untreated children and titrated for over 8 weeks to efficacious target doses for each drug, then maintained for another 24 weeks (maintenance phase). LMT was introduced at a mean dose of 4.7 (1-10) mg/kg/day and CBZ was introduced at a mean dose of 14.9 (10-20) mg/kg/day. The primary endpoint was change from screening to the end of the maintenance phase in a combined analysis of standardized measures of cognition and behavior. Results: Out of 56 patients who were enrolled, 53 patients completed the study. During the experiment, the percentage of patients who were seizure-free did not differ between the treatment groups ( 79.3% LMT, 84.0% CBZ; p=0.736 ). Neuropsychological data were available for 56 patients (32 patients for LMT and 24 patients for CBZ). Of the cognitive variables measured, Full Scale IQ showed a tendency towards improvement for LTG as opposed to a tendency to aggravation for CBZ. Other variables followed the same tendencies for Verbal comprehension and Concentration (subdomain of IQ), and Abstraction and Comprehension (subscale of IQ), though these were not up to statistically significant levels. As for the behavioral variables, no significant changes were found, but the score had a positive trend for LTG in Social Ability and Academic Achievement scales and a tendency towards worsening for CBZ in Somatization, Depression/Anxiety, Concentration and Aggression scales. A particularly significant worsening in Delinquent Behavior was noted for CBZ. Conclusions: LMT has benefits to improve various aspects in cognition and behavior as compared with CBZ, although there is no significant difference between two groups, in treating childhood partial epilepsy.