A Korean Open-label, Multi-center, Community-based Trial Assessing the Efficacy and Safety of Levetiracetam as Adjunctive Therapy in Adult Subjects With Uncontrolled Partial Epilepsy for Bridging Purpose With a Similar Study on Caucasian Epileptic Subjects

UCB Pharma0 个研究点目标入组 100 人开始时间: 2004年3月最近更新: 2013年11月26日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: UCB Pharma
入组人数: 100
主要终点: To evaluate efficacy of levetiracetam in community based practice (seizure frequency per week over 16 weeks).

A Korean open-label, community-based trial assessing the efficacy and safety of levetiracetam as adjunctive therapy in partial epilepsy.

Similarity with a similar study conducted in Caucasian epileptic subjects will be assessed.

•Subjects with epilepsy experiencing partial seizures, whether or not secondarily generalized.
•Subjects must present between 3 and 42 partial seizures over the three months prior to protocol Visit
•Use of one (1), but no more than two (2) concomitant marketed AEDs at the time of trial entry.

•Subjects on felbamate with less than 18 months exposure.
•Subjects on vigabatrin, whose visual field has not been assessed as per recommendation of the manufacturer, i.e. every 6 months.
•Presence of known pseudoseizures within the last year.
•Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors.
•Uncountable seizures (clusters) or history of convulsive status epilepticus within the last five years.

To evaluate efficacy of levetiracetam in community based practice (seizure frequency per week over 16 weeks).

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