目的:本研究旨在探讨其安全性,耐受性,功效,和Pynegabine作为局灶性癫痫治疗的附加疗法的药代动力学。
方法:这是一个协议阶段-IIa,随机化,双盲,安慰剂对照,来自中国多个中心的局灶性癫痫患者的多中心研究,这些患者接受了至少2种ASM治疗,但没有有效控制。该研究涉及8周的磨合期,稳定使用以前的药物。然后将患者随机分配以接受Pynegabine或安慰剂。哨兵管理最初是进行的,随后的患者根据安全性评估进行随机化.建立三个剂量组(15、20和25mg/d)。通过各种措施评估疗效,包括癫痫发作频率,CGI评分,PGI评分,HAMA得分,HAMD得分,MoCA量表评分,QOLIE-31量表评分,和12h-EEG评分。安全评价,PK血样,合并用药,并记录不良事件.
结论:来自研究的数据将用于评估安全性,耐受性,功效,和吡南他滨片作为局灶性癫痫的附加疗法的药代动力学。
OBJECTIVE: This study aims to investigate the safety, tolerability, efficacy, and pharmacokinetics of Pynegabine as an add-on therapy in the treatment of focal epilepsy.
METHODS: This is a protocol phase-IIa, randomized, double-blinded, placebo-controlled, multicenter study in patients with focal epilepsy from multiple centers in China who have been treated with at least 2 ASMs without effective control. The study involves an 8-week run-in period with stable use of previous medications. Patients are then randomized to receive either Pynegabine or a placebo. Sentinel administration is performed initially, and subsequent patients are randomized based on safety assessments. Three dose cohorts (15, 20, and 25 mg/d) are established. Efficacy is assessed through various measures, including seizure frequency, CGI score, PGI score, HAMA score, HAMD score, MoCA scale score, QOLIE-31 scale score, and 12 h-EEG score. Safety evaluations, PK blood samples, concomitant medications, and adverse events are also recorded.
CONCLUSIONS: Data from the study will be used to evaluate the safety, tolerability, efficacy, and pharmacokinetics of Pynegabine tablets as add-on therapy for focal epilepsy.