[Translation] A multicenter, double-blind, randomized, placebo-controlled evaluation of the efficacy and safety of lacosamide as a combination therapy for the treatment of partial-onset epilepsy in children aged 1 month to 4 years
本研究的主要目的在于评价拉考沙胺与1~3种抗癫痫药物(AED)合并给药治疗目前患有未控制的部分性发作癫痫的受试者(1个月≤年龄<4岁)的有效性。 次要目的为评价拉考沙胺治疗目前患有未控制的部分性发作癫痫的受试者(1个月≤年龄<4岁)的安全性和耐受性。 其他目的为评价拉考沙胺在1个月≤年龄<4岁的儿童中的药代动力学(PK)。
[Translation] The primary objective of this study was to evaluate the efficacy of lacosamide in combination with 1 to 3 antiepileptic drugs (AEDs) in subjects (1 month ≤ age < 4 years) currently suffering from uncontrolled partial-onset epilepsy. The secondary objective was to evaluate the safety and tolerability of lacosamide in subjects (1 month ≤ age < 4 years) currently suffering from uncontrolled partial-onset epilepsy. Other objectives were to evaluate the pharmacokinetics (PK) of lacosamide in children 1 month ≤ age < 4 years.