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Oxcarbazepine Shows Promise as Adjunctive Therapy in Infants and Children With Partial Seizures: Presented at AAN

By Jill Stein

MIAMI, FL -- April 13, 2005 -- Oxcarbazepine is a valuable treatment option for the management of infants and young children with inadequately controlled partial seizures, researchers announced on April 13^th at the American Academy of Neurology 57^th Annual Meeting.

Jesus E. Pina-Garza, MD, assistant professor of neurology, Vanderbilt University Medical Center, Nashville, Tennessee, United States, presented the results of a study that evaluated the efficacy and safety of low- versus high-dose oxcarbazepine as adjunctive therapy in 128 patients aged 1 month to less than 4 years who had inadequately controlled partial seizures.

Eligible patients had a diagnosis of simple and complex partial seizures evolving to secondarily generalised seizures, an electroencephalogram (EEG) prior to entering the study that showed focal epileptiform discharges and/or a focal abnormality, and had been maintained on up to 2 concomitant antiepileptic drugs for at least 7 days before and during the baseline and treatment phase.

Participants were stratified by age and randomised in a 1:1 ratio to receive adjunctive oxcarbazepine at either a low dose of 10 mg/kg/day or a high dose of 60 mg/kg/day.

Patients randomised to low-dose oxcarbazepine received 10 mg/kg/day for 9 days, and those assigned to high-dose oxcarbazepine initially received 10 mg/kg/day for 5 days, titrated up 10 mg/kg/day at 5-day intervals to a maximum of 60 mg/kg/day maintained for 9 days.

Patients in both groups were hospitalised for the last 72 hours of the 9-day maintenance period during which seizures were recorded by continuous video-EEG.

Among the 115 patients who completed the trial, statistically significant differences between the 2 dosing groups were seen in terms of median absolute change (-1.37 vs -2.00 seizures; P =.043) and median percent change (-46.18 vs -83.33; P =.047) in study-defined seizure frequency per 24 hours.

The overall incidence of adverse effects was lower for the low-dose group than the high-dose group (40.6% vs 73.4%). The most frequent adverse effects were pyrexia and somnolence. Most adverse side effects were mild in severity.

The drug's overall safety profile was consistent with that previously reported for adults and older children, Dr. Pina-Garza noted.

"The results of the trial show that high-dose oxcarbazepine adjunctive therapy is significantly more effective than low-dose oxcarbazepine in controlling partial seizures in infants and young children," he concluded.

Epilepsy affects roughly 1% of all children up to the age of 16 years and is defined as at least 2 unprovoked seizures occurring more than 24 hours apart in a child greater than 1 month old. Despite increased and improved pharmacologic options for the treatment of epilepsy, 25% of children with epilepsy are refractory to standard therapy.

The trial was sponsored by Novartis.


[Presentation title: Oxcarbazepine as Adjunctive Therapy Is Effective and Safe in Infants and Very Young Children With Inadequately-Controlled Partial Seizures. Abstract P03.102]

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