The safety and efficacy of oxcarbazepine (OXC) as adjunctive therapy for refractory partial seizures were evaluated in 267 patients in a multicenter (47 centers in 8 countries; Argentina, Chile, Uruguay, Australia, New Zealand, Canada, Israel, and the USA), randomized, placebo-controlled trial, and reported from the Children’s Hospital, Cincinnati, OH. Children, aged 3 to 17 years, with inadequately controlled seizures and taking one or two concomitant antiepileptic drugs, received either OXC 6 to 51 mg/kg/day (median, 31 mg/kg/d) orally or a placebo, in a 112-day double-blind treatment phase.
The median percent reduction from baseline seizure frequency (56-day preliminary observation period) was 35% versus 9% for OXC and placebo groups, respectively (p=0.0001). The percent of patients with a >50% reduction in seizure frequency per 28 days was 41% for the OXC group and 22% with placebo (p=0.0005). Adverse events were reported in 91% and 82% of the OXC and placebo groups, respectively. A twofold or greater incidence of vomiting, somnolence, dizziness, and nausea occurred in children treated with OXC. Fourteen patients (10%) in the OXC group and 4 (3%) on placebo discontinued treatment prematurely due to adverse events. The OXC-related side effects necessitating drug withdrawal were nausea and vomiting in 5, and rash in 4. [1]
COMMENT. Oxcarbazepine is considered effective as an adjunctive antiepileptic therapy in children with inadequately controlled partial seizures.
Oxcarbazepine monotherapy for partial-onset seizures was studied in a multicenter, double-blind trial in outpatients aged 12 years or older with inadequately controlled seizures [2]. Patients receiving a higher dosage (2400 mg/day) of OXC were benefited more than those on a lower dose (300 mg/day); 12% seizure-free compared to none, respectively.