Abstracts

This study evaluated the efficacy and safety of low- vs. high-dose oxcarbazepine (OXC) monotherapy in patients 1 month to [lt]17 years with inadequately controlled partial seizures. Hospitalized patients were randomized in a 1:1 ratio to receive either 10 or 40-60 mg/kg/day of OXC monotherapy for 5 days. Patients were stratified by age as follows: 1-[lt]6, 6-[lt]12, 12-[lt]24, 24-[lt]48 months, or 4-[lt]8 and 8-[lt]17 years. Patients were either newly diagnosed or had inadequately controlled seizures on another monotherapy antiepileptic drug (AED) treatment. Patients had experienced 2-30 partial seizures 7 days prior to randomization (clinical seizures as reported by caregivers). For patients receiving monotherapy with another AED at entry, the AED dose was reduced by 50% on Day 2 and discontinued on Day 3. Patients completed the study by either completing the OXC treatment phase or by meeting one of two exit criteria based upon seizure frequency/severity. Seizures were measured by continuous video-EEG monitoring beginning with the first OXC dose on Day 3. Seizure records were assessed by a central reader blinded to study treatment. Of 92 patients randomized, 46 received high- and 46 received low-dose OXC. Results showed no significant difference (p=0.904) in exit rates between the two treatment groups. The majority of patients in both groups completed the 5-day treatment. The exit rates of the high- and low-dose groups were 19.6% and 21.7% respectively, both better than the assumed rate of 35% of high-dose- and 70% of low-dose-treated patients as found in an adult presurgical study (Schachter, Neurology, 1999). Adverse events were reported for 21 (45.7%) low-dose- and 28 (60.9%) high-dose-treated patients. The most frequent AEs ([gt]10% in either group) were somnolence, dizziness, nausea and vomiting. This is the first reported controlled study of OXC monotherapy in infants as young as 1 month of age. The non-separation between the groups (due to a low exit rate in both groups) may have been caused by various factors e.g., efficacy of the 10 mg/kg dose and/or absence of a clear diagnosis of partial seizures in a very young patient population. The drug was well-tolerated with a safety profile in line with previous findings in adults and older children. (Supported by Novartis Pharmaceuticals)