Phase III study of KW-6485P for pediatric patients with symptomatic or cryptogenic localization-related epilepsy

Kyowa Hakko Kirin Co., Ltd.0 个研究点目标入组 60 人开始时间: 2010年7月14日最近更新: 2023年10月17日

研究概览

暂无简介。

•Patients who have been diagnosed with symptomatic or cryptogenic localization-related epilepsy
•- Patients who have simple partial seizure, complex partial seizure, or secondarily generalized seizure
•- Patients who have provided written informed consent from guardian
•- Patients must weigh at least 10 kg
•- Patients who have any epilepsy therapy for 6 months or more
•- Patients who are treated with 1 to 3 antiepileptic drugs
•- Patients who have no progressive disease of central nervous system with imaging diagnosis

•- Patients with status epilepticus within 3 months
•- Patients with seizures secondarily to a treatable diseases
•- Patients with seizures other than partial seizures
•- Patients with seizures occurring only in clustered patterns
•- Patients with a serious disorder of cardiac, hepatic, renal, pulmonary, hematologic, metabolic, or endocrinologic system
•- Patients with a progressive neurological disorder
•- Patients with a complication or history of severe psychiatric symptom
•- Patients with a history of renal or urinary calculus
•- Patients with a complication or history of angle-closure glaucoma
•- Patients with a prior exposure to topiramate

发起方

Kyowa Hakko Kirin Co., Ltd.