An Open Label, Single-Arm, Multi-Center Study on the Efficacy, Safety and Pharmacokinetics of Levetiracetam in Pediatric Patients (4 to 16 Years) With Partial Seizures Despite Treatment With 1 or 2 Anti-Epileptic Drugs

CB Japan Co. Ltd.0 个研究点目标入组 70 人开始时间: 2015年2月16日最近更新: 2015年2月23日

适应症

试验速览

暂无简介。

•- The patient has partial Epilepsy and the diagnosis must be confirmed in the last 6 months
•- The patients must be on a stable 1 or 2 anti-epileptic drug(s) treatment during the 4 weeks prior to Baseline and must have at least 8 partial seizures during the 8-week prospective Baseline Period
•- Patient at the age of 4 to 16 years, and at the body weight of 11 to 82 kg
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 70
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•- The patient has a treatable seizure etiology
•- The patient has Epilepsy secondary to a progressive cerebral disease or any other progressively neurodegenerative disease, including Rasmussen and Landau-Kleffner diseases
•- The patient has a history of status Epilepticus during the 3 months prior to Visit 1
•- The patient has a past and present history of pseudo seizures
•- The patient has a current diagnosis of Lennox-Gastaut syndrome

发起方

CB Japan Co. Ltd.