The aim of this multicentric, prospective and uncontrolled study was to evaluate the efficacy and safety of levetiracetam in 110 children with refractory epilepsy, of whom 21 were less than 4 years old. After a median follow-up period of 7 months, levetiracetam administration was effective (responders with >50% decrease in seizure frequency) in 39% of children, of whom 10 (9%) became seizure-free. The efficacy was higher in patients with localization-related epilepsy (58% of responders) than in those with generalized epilepsy (37% of responders). Levetiracetam was well tolerated. The main side effects of somnolence and irritability occurred in 14% of patients. In one patient acute choreoathetosis occurred after few doses of levetiracetam. Overall, the adverse effects were not severe. Children younger than 4 years were particularly tolerant. In conclusion, the present study confirms that levetiracetam is effective and well tolerated as an add-on treatment in children with refractory epilepsy. Our preliminary data also indicate that levetiracetam may be a valid therapeutic option for epilepsy in infants and young children. © 2005 BEA Trading Ltd. Published by Elsevier Ltd. All rights reserved.
Grosso, S., Franzoni, E., Coppola, G., Iannetti, P., Verrotti, A., Cordelli, D. M., … Balestri, P. (2005). Efficacy and safety of levetiracetam: An add-on trial in children with refractory epilepsy. Seizure, 14(4), 248–253. https://doi.org/10.1016/j.seizure.2005.02.004