Abstracts

The antiepileptic drug (AED) oxcarbazepine (OXC) is approved as monotherapy or adjunctive therapy for the treatment of partial seizures in adults and children. While some AEDs may impair cognitive function, OXC has not been found to affect cognitive function in adults with epilepsy. This study was designed to assess the effect of OXC on cognitive function in children and adolescents with partial seizures. This multicenter, open-label, randomized, active-control study included previously untreated patients 6 to [lt]17 years old with a history of [ge]2 unprovoked partial seizures. Patients were randomized to receive OXC, carbamazepine (CBZ), or valproate (VPA) in a 2:1:1 ratio for 6 months. Patients were stratified by age group (6 to [lt]12 years and 12 to [lt]17 years). The primary endpoint was the Computerized Visual Searching Task (CVST) assessing mental information processing speed and attention. Secondary endpoints included psychomotor speed and alertness (assessed by finger-tapping and visual reaction-time tasks), memory and learning (assessed by recognition of words and figures and the Rey Auditory Verbal Learning Test), mental information processing speed and attention (assessed by binary choice reaction time), and an intelligence test (Raven[rsquo]s Standard Progressive Matrices). Comparisons were made between patients receiving OXC and the combined group of patients receiving CBZ or VPA after 6 months[rsquo] treatment (ANCOVA). Overall, 112 patients (mean age: 10 years) were randomized to treatment with OXC (n=55), CBZ (n=28), or VPA (n=29). In total, 99 patients (88.4%) completed the study, and 97 were eligible for assessment of the primary endpoint. Median daily doses were OXC 770 mg, CBZ 600 mg, and VPA 600 mg. The primary endpoint comparison of mean change in CVST measurements at 6-months from baseline was -3.902 s (OXC) and -0.999 s (CBZ/VPA) indicating an improvement for both treatment groups (p=0.195). The analyses of secondary neuropsychological variables did not show any significant differences between treatment groups. Adverse events ([gt]10%) included fatigue and headache in the OXC group, fatigue and rash in the CBZ group, and headache, increased appetite, and alopecia in the VPA group. The results indicate that there is no difference between OXC and other standard first-line AED therapies in their effects on cognitive function in children and adolescents aged 6 to [lt]17 years with newly diagnosed partial seizures. From the baseline data over the time course of 6 months, there is no evidence derived from this study that OXC adversely affects cognitive function in children and adolescents with partial seizures. All AEDs were well tolerated and the safety profile of OXC was in line with previous findings. (Supported by Novartis Pharmaceuticals)