Effects of ethyl loflazepate on refractory epilepsy in children.
We evaluated the safety and efficacy of ethyl loflazepate in children with epilepsy. The study group comprised 21 outpatients (4 by generalized, 17 by localization-related) aged between 9 months and 17 years. Ethyl loflazepate was administered at a dose of 0.015 mg/kg/day twice daily. The final mean dose was 1.35 mg/day. The mean number of prior antiepileptic drugs was 5.7. The entire treatment period was more than 24 months after ethyl loflazepate administration. Six children (28.6%) became seizure-free for the entire study 6 months after administration, 11 (52.4%) had a seizure reduction of more than 50% for over entire 24 months. The mean number of co-medications was 2.4. Adverse events occurred in only 1 patient. Responders, defined as reduction of ≥50% in seizure frequency, included 2/2 of patients with West syndrome and 15/17 (88.2%) with localization-related epilepsy. Ethyl loflazepate represents an important addition to the treatments available for refractory epilepsies in children.