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Cenobamate (YKP3089) as adjunctive treatment for uncontrolled focal seizures in a large, phase 3, multicenter, open‐label safety study
Epilepsia ( IF 5.6 ) Pub Date : 2020-05-12 , DOI: 10.1111/epi.16525
Michael R Sperling 1 , Pavel Klein 2 , Sami Aboumatar 3 , Michael Gelfand 4 , Jonathan J Halford 5 , Gregory L Krauss 6 , William E Rosenfeld 7 , David G Vossler 8 , Robert Wechsler 9 , Leona Borchert 10 , Marc Kamin 10
Affiliation  

During the development of cenobamate, an antiseizure medication (ASM) for focal seizures, three cases of drug reaction with eosinophilia and systemic symptoms (DRESS) occurred. To mitigate the rate of DRESS, a start‐low, go‐slow approach was studied in an ongoing, open‐label, multicenter study. Also examined were long‐term safety of cenobamate and a method for managing the pharmacokinetic interaction between cenobamate, a 2C19 inhibitor, and concomitant phenytoin or phenobarbital.

中文翻译:

在一项大型、3 期、多中心、开放标签安全性研究中,Cenobamate (YKP3089) 作为不受控制的局灶性癫痫发作的辅助治疗

在针对局灶性癫痫发作的抗癫痫药 (ASM) cenobamate 的开发过程中,发生了 3 例伴有嗜酸性粒细胞增多和全身症状 (DRESS) 的药物反应。为了降低 DRESS 的发生率,在一项正在进行的、开放标签、多中心的研究中研究了一种从低到高的方法。还检查了西诺巴酯的长期安全性以及管理西诺巴酯(一种 2C19 抑制剂)与苯妥英或苯巴比妥之间药代动力学相互作用的方法。
更新日期:2020-05-12
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