Abstracts

The safety and tolerability of oxcarbazepine as monotherapy and adjunctive therapy in infants and children 1 month to [lt]4 years of age was assessed in two open-label pilot studies (Duchowny et al. Eur J Neurol 2003;10:148 [P2082]; Hernandez et al. Neurology 2003;60 Suppl 1:A145). Safety and tolerability data from the 6-month extension phases of both studies are reported here. Pediatric patients completing the treatment phases of the two pilot studies were included in the 6-month open-label extension phases. During the treatment phases, patients had received oxcarbazepine oral suspension as either monotherapy or adjunctive therapy. During the extension phases, patients could receive oxcarbazepine dosages of up to 60 mg/kg/day, adjusted to individual efficacy and tolerability. Concomitant use of antiepileptic drugs (AEDs) was allowed. Safety assessments for adverse events (AEs), vital signs, ECG, and laboratory tests were performed at 2, 6, 10, 18, and 26 weeks after entry into the extension phases. A total of 24 children (13 male, 11 female) were included in the 6-month extension phases of the two studies. The median (range) age, weight, and height were 17 (2-42) months, 11.3 (4.7-16.7) kg, and 82 (55-99) cm, respectively. A total of 15 (62.5%) patients completed the extension phases. The median (range) treatment duration during the extension phases was 182 (15-231) days. The median (range) oxcarbazepine dose was 49.3 (5.3-60.9) mg/kg/day. Seven (29%) patients remained on oxcarbazepine monotherapy during the treatment and extension phases; 17 (71%) patients received oxcarbazepine adjunctive therapy during the extension phases. Three (12.5%) patients discontinued because they no longer required AED therapy. One (4.2%) patient receiving adjunctive therapy discontinued due to AEs (fatigue, irritability, and ataxia). The most frequent AEs ([ge]20%), regardless of relationship to oxcarbazepine, were pyrexia, ear infection, irritability, nasal congestion, upper respiratory tract infection, lethargy, and nasopharyngitis. There were no new safety findings identified by laboratory tests, vital signs, ECG, or physical examination during this study. Oxcarbazepine was safe and well tolerated as monotherapy and adjunctive therapy in infants and very young children ([lt]4 years of age) over a 6-month period. (Supported by Novartis Pharmaceuticals)