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my personal edition > epilepsy > news
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DGDispatch
Low-Dose Oxcarbazepine Well Tolerated In Infants, Adolescents With Partial Seizures: Presented at AES
By Bonnie Darves
NEW ORLEANS, LA -- December 9, 2004 -- The relatively new antiepileptic drug oxcarbazepine as monotherapy may provide safe seizure control in infants and young children with poorly controlled or new-onset seizures, even a low doses.
The findings were presented here on December 7th at the American Epilespy Meeting Annual Meeting.
The multicentre randomized study enrolled 92 patients aged 1 month to 17 years, said study co-author Ricardo Ayala, neurologist, Tallahassee Neurological Clinic, Tallahassee, Florida, United States.
Results show that there was no statistically significant difference in efficacy rates between the 10 mg/kg.day and 60 mg/kg/day, and exit rates for the the two groups were similar, the researcher said.
Perhaps because of the study's short duration -- conducted over 5 days, with continuous video electroencephalographic (EEG) monitoring, there was no difference in mean rates of partial-seizures between the low-dose and high-dose groups, and the drug was well tolerated, Dr. Ayala said. Mean daily seizure frequency was 1.0 in the low dose group and 1.3 in the high-dose group.
Study subjects were on at least one concomitant antiepileptic at randomisation and had discontinued all other antiepileptic therapy a week prior to pre-randomisation. They were hospitalised for the 5-day period for initiation of, or conversion to oxcarbazepine monotherapy.
Six patients (7%) discontinued the study treatment prematurely because of either adverse events or administrative problems. Common adverse events were dizziness, somnolence, nausea and vomiting, but all adverse events occurred only in the high-dose group and affected 10% of these patients. There were no unexpected findings on electroencephalographic EEG or vital sign measurements, Dr. Ayala added.
He noted that the low dose, 10 mg/kg daily, is equivalent to the adult dose of 600 mg/kg daily, which has been shown to reduce seizure frequency significantly in adults.
The study was supported by Novartis.
[Presentation title: "A Multi-Center, Rater-Blind, Randomized, Age-Stratified, Parallel-Group Study Comparing High- Vs. Low-Dose Oxcarbazepine Monotherapy in Pediatric Patients With Inadequately-Controlled Partial Seizures." Abstract 2.375]
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