RESCUE ESES: Randomized European Trial of Steroids versus Clobazam Usage for Encelopathy with ESES. Corticosteroids or clobazam for ESES syndrome: a European, multicenter, randomized, controlled clinical trial. - RESCUE ESES

niversity Medical Centre Utrecht0 个研究点目标入组 130 人开始时间: 2014年5月16日最近更新: 2015年3月16日

适应症

试验速览

暂无简介。

•-Age 2 up to 12 years (not including children of 12 years old);
•-A diagnosis within six months prior to study inclusion (preferably as close to inclusion as possible) of either typical or atypical ESES syndrome (as defined in the study protocol)
•-No previous treatment with either corticosteroids or clobazam
•-No current treatment nor in the previous three months with carbamazepine, oxcarbazepine, vigabatrin, tiagabine, gabapentin and pregabalin
•-Written informed consent by parents / legal representatives
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 130
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Patients with a spike wave index (SWI) during wakefulness of > 50%
•Acute or chronic infectious disease (e.g. TB, HIV)
•Immunodeficiency
•Severe osteopenia/osteoporosis
•Cushing syndrome
•Severe respiratory insufficiency
•Severe liver failure
•Severe ulcera
•Any other condition that, in the investigator’s judgement, contra-indicates the use of corticosteroids or clobazam.

发起方

niversity Medical Centre Utrecht