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From the Children’s Hospital (Dr. Glauser), Department of Neurology, Cincinnati, OH; Children’s Hospital of Michigan (Dr. Nigro), Division of Neurology, Detroit, MI; New Jersey Comprehensive Epilepsy Center (Drs. Sachdeo and Mandelbaum), New Brunswick, NJ; CENTUC, San Miguel de Tucuman (Dr. Pasteris), Argentina; Children’s Hospital, Department of Neurology, (Dr. Weinstein) Washington, DC; Vanderbilt University, (Dr. Abou-Khalil), Medical Center, Nashville TN; Neuro-Development Center, Child & Adolescent Neurology (Dr. Frank), Norfolk, VA; Sanatorio Morra (Dr. Grinspan), Cordoba, Argentina; Pediatric Neuro (Dr. Guarino), San Jose, CA; Pediatric Neurology of Idaho (Dr. Bettis), Boise, ID; Barrow Neurological Institute, Epilepsy Clinic (Dr. Kerrigan), Phoenix, AZ; L’Hospital Ste-Justine, Service de Neurologie (Dr. Geoffroy), Montreal, Quebec, Canada; Novartis Pharmaceuticals Corporation (Drs. Jacobs, Mesenbrink, Kramer, and D’Souza), East Hanover, NJ.
Address correspondence and reprint requests to Dr. Tracy A. Glauser, Children’s Hospital Medical Center, Department of Neurology, OSB-5, 3333 Burnet Avenue, Cincinnati, OH 45229.
OBJECTIVE: To evaluate the safety and efficacy of oxcarbazepine (OXC) as adjunctive therapy in children with inadequately controlled partial seizures on one or two concomitant antiepileptic drugs (AEDs).
BACKGROUND: OXC has shown antiepileptic activity in several comparative monotherapy trials in newly diagnosed patients with epilepsy, and in a placebo-controlled monotherapy trial in hospitalized patients evaluated for epilepsy surgery.
DESIGN: A total of 267 patients were evaluated in a multicenter, randomized, placebo-controlled trial consisting of three phases: 1) a 56-day baseline phase (patients maintained on their current AEDs); 2) a 112-day double-blind treatment phase (patients received either OXC 30–46 mg/kg/day orally or placebo); and 3) an open-label extension phase. Data are reported only from the double-blind treatment phase; the open-label extension phase is ongoing.
METHODS: Children (3 to 17 years old) with inadequately controlled partial seizures (simple, complex, and partial seizures evolving to secondarily generalized seizures) were enrolled.
RESULTS: Patients treated with OXC experienced a significantly greater median percent reduction from baseline in partial seizure frequency than patients treated with placebo (p = 0.0001; 35% versus 9%, respectively). Forty-one percent of patients treated with OXC experienced a 
50% reduction from baseline in partial seizure frequency per 28 days compared with 22% of patients treated with placebo (p = 0.0005). Ninety-one percent of the group treated with OXC and 82% of the group treated with placebo reported 1 adverse event; vomiting, somnolence, dizziness, and nausea occurred more frequently (twofold or greater) in the group treated with OXC.
CONCLUSION: OXC adjunctive therapy administered in a dose range of 6 to 51 mg/kg/day (median 31.4 mg/kg/day) is safe, effective, and well tolerated in children with partial seizures.
Key words: Oxcarbazepine—Pediatric epilepsy—Partial seizures—Antiepileptic drugs—Adjunctive therapy—Trileptal.
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