Peramapnel First-line Monotherapy in Idiopathic Gneralized Epilepsy - PREFIE Study

Masuda Yosuke0 个研究点目标入组 30 人开始时间: 2023年4月28日最近更新: 2024年1月22日

试验速览

暂无简介。

•(1) 12 years of age or older
•(2) Idiopathic generalized epilepsy (myoclonic, absence, or tonic-clonic seizures confirmed by interview and consistent with idiopathic generalized epilepsy on EEG)
•(3) Patients who have obtained written consent from the patient or a surrogate

•(1) Patients over 80 years of age
•(2) Patients with moderate or severe renal dysfunction (eGFR<60 mL/min/1.73 m2 )
•(3) Patients with hepatic dysfunction of moderate severity or greater (AST or ALT greater than 2.5 times the upper limit of the reference value or total bilirubin greater than 1.5 times the upper limit of the reference value)
•(4) Complications of non-epileptic psychogenic seizures (if the patient has a history of epileptic seizures, patients without psychogenic seizures for more than 2 years are not excluded)
•(5) Patients with complications of other epilepsy syndromes such as focal epilepsy and unclassifiable epilepsy
•(6) Acute symptomatic seizures (e.g., convulsive seizures caused by head trauma, stroke, or encephalitis)
•(7) History of epileptic seizures
•(8) History of severe drug allergy
•(9) Inability of the patient or family member to keep an observation diary
•(10) Female patients of childbearing potential who cannot use an acceptable method of contraception
•(11) Female patients who are pregnant (or planning to become pregnant) or lactating
•(12) Patients with a history of serious adverse reactions to perampanel
•(13) Patients who have been treated with antiepileptic drugs for more than 8 days
•(14)Patients who are deemed inappropriate as research subjects by the investigator or others

发起方

Masuda Yosuke