A multi-center, uncontrolled, open-label, evaluation of lamotrigine monotherapy in adult subjects with newly diagnosed epilepsy or recurrent epilepsy (currently untreated).

GlaxoSmithKline K.K. (GSK)0 个研究点目标入组 65 人开始时间: 2016年12月21日最近更新: 2017年1月9日

适应症

试验速览

暂无简介。

•Subjects with newly diagnosed epilepsy or recurrent epilepsy which is untreated, having partial seizures (including secondarily generalization) or generalized tonic-clonic seizures; subjects having a confident diagnosis of epilepsy uncomplicated by pseudoseizures (psychogenic nonepileptic seizures); subjects having had at least 2 seizures in the previous 6 months with at least 1 seizure in the previous 3 months; outpatients aged =16 years at the time of obtaining consent who are able to write a seizure diary; subjects having no other seizure types than partial seizures or generalized tonic-clonic seizures with or without myoclonus; subjects having no status epilepticus within the 6 months prior to the start of study treatment; subjects without a history of treatment with antiepileptic drugs (=2 weeks) during 6 months before the start of treatment with the investigational product; and subjects without a history of treatment with lamotrigine.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 7
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 47
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 13

发起方

GlaxoSmithKline K.K. (GSK)