ONO-2017-01:ONO-2017 phase III studyA multicenter, open-label study in Japanese patients with primary generalized tonic clonic seizures.

Osawa Masahiro0 个研究点目标入组 12 人开始时间: 2022年2月23日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1.Gender and age: Japanese patients, regardless of gender, aged 18 years or older at the time of informed consent.
•2. Subject has a clinical diagnosis of PGTC seizures in the setting of idiopathic generalized epilepsy.
•3.Subject experiences at least 5 PGTC seizures in 12 weeks.
•4.Subject is currently receiving 1 to a maximum of 3 concomitant AEDs with fixed dosing regimens.

•1. Subject has a history of status epilepticus that required hospitalization within 15 months prior to enrollment.
•2. Subject has PGTC seizure clusters where individual seizures cannot be counted orclassified.
•3. History of non-epileptic or psychogenic seizures.
•4. Subject has a concomitant diagnosis of POS.
•5. Subject has a history of any serious drug-induced hypersensitivity reaction (including but not limited to Stevens Johnson syndrome, toxic epidermal necrolysis, DRESS, Drug-induced hypersensitivity syndrome(DIHS)) or any drug-related rash requiring hospitalization.

发起方

Osawa Masahiro