Abstracts

RATIONALE: A double blind, placebo-controlled 16 week trial of oxcarbazepine (OXC) adjunctive therapy demonstrated efficacy and safety in controlling partial-onset seizures in children. (Neurology 2000;54:2237-2244). Following completion of the double-blind treatment trial, children could enter a long-term open label extension phase in which OXC therapy was adjusted under conditions corresponding more to regular clinical practice. The purpose of this study was to evaluate the efficacy and safety of long-term OXC therapy in children with partial-onset seizures who had completed the double-blind placebo controlled OXC trial.
METHODS: The extension study began with a 2-week, double-blind transition period that allowed patients treated with placebo to be titrated to the trial OXC target dose (30-46 mg/kg/day). This phase was followed by a long-term, open-label phase in which the dosages of OXC and concomitant AEDs were adjusted according to clinical response. Patients were seen every 2 weeks for the first 2 months and then every 3 months thereafter. Seizure frequency and side effect profile were analyzed for the first 56 weeks of OXC therapy.
RESULTS: A total of 229 children, aged 3-17 years (mean age, 11.2 years) entered into the open label extension phase. Efficacy and side effect frequency was calculated based on an intent to treat analysis. Compared to their baseline seizure frequency, 50.2% of the patients experienced a [gt] 50% reduction in seizure frequency and 7.0% were seizure free throughout the first 56 weeks of open label therapy. The most common adverse events were headache (31%), vomiting (27%) and dizziness (26%), all with a median duration of 1.0 days. No patients discontinued due to laboratory abnormalities and no deaths occurred. 150 children (66%) completed at least one year of open label therapy. The reasons for exiting the trial included unsatisfactory seizure control (18%), adverse events (6%), and other (10%).
CONCLUSIONS: These results indicate that OXC maintains its safety and efficacy as adjunctive therapy during long-term management of partial-onset seizures in children. A substantial proportion of patients remained seizure-free for an extended period of time. Side effects noted were mild to moderate in severity and transient.
Support: Novartis Pharmaceuticals
Disclosure: Salary - Joseph D[ssquote]Souza (an employee of Novartis Pharmaceuticals) Grant - Tracy A. Glauser, Rajesh Sachdeo, Ahmad Beydoun, Michael Nigro Equity - Joseph D[ssquote]Souza (an employee of Novartis Pharmaceuticals) Consulting - Tracy A. Glauser, Rajesh Sachdeo, Ahmad Beydoun, Michael Nigro Stock - Joseph D[ssquote]Souza (an employee of Novartis Pharmaceuticals) Honoraria - Tracy A. Glauser, Rajesh Sachdeo, Ahmad Beydoun, Michael Nigro