Open-label Study of Levetiracetam Intravenous Infusion in Children (1 Month-4 Years Old) With Epilepsy

The primary objective of this study was to evaluate the safety and tolerability of levetiracetam intravenous 15-minute infusion administered every 12 hours, either as adjunctive treatment or monotherapy in children (1 month to 4 years old) with epilepsy (except status epilepticus), either after switching from the equivalent levetiracetam oral dose administration or as a new antiepileptic treatment. The evaluation period was to be considered as one complete set of 4 pharmacokinetic (PK) samples for a maximum of 4 days; For children already taking levetiracetam oral solution prior to entering the study, the levetiracetam intravenous (LEV IV) dose will be equivalent (mg-for-mg) to their oral dose (always in twice daily regimen) within the following dose range, calculated on the basis of their age and weight: * Children ≥ 1 month to \< 6 months: 14 mg/kg/day (i.e. 7 mg/kg twice daily) to 42 mg/kg/day (i.e 21 mg/kg/day twice daily); * Children ≥ 6 months to \< 4 years:20 mg/kg/day (i.e. 10 mg/kg twice daily) to 60 mg/kg/day (i.e 30 mg/kg/day twice daily). The first intravenous (IV) infusion was to be administered 12 hours after the last oral dose of levetiracetam. For children not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dose will correspond to their age and weight as follows: * Children ≥ 1 month to \< 6 months: 14 mg/kg/day (i.e. 7 mg/kg twice daily). * Children ≥ 6 months to \< 4 years: 20 mg/kg/day (i.e. 10 mg/kg twice daily). However, when necessary for the safety of the subject or when the investigator deemed it appropriate the levetiracetam intravenous (LEV IV) dose could be modified after one day. Subjects were hospitalized for the duration of the levetiracetam intravenous (LEV IV) treatment.