A multicenter, open-label, randomized, parallel-group, active-controlled study comparing the efficacy and safety of Levetiracetam to Carbamazepine used as monotherapy in subjects (=16 years) newly or recently diagnosed as suffering from epilepsy and experiencing partial seizures

CB Pharma SA0 个研究点目标入组 436 人开始时间: 2015年11月12日最近更新: 2015年11月16日

研究概览

暂无简介。

•Subject is of Chinese origin and = 16 years of age
•Subject is newly or recently diagnosed with Epilepsy, having experienced unprovoked Partial-Onset Seizures (POS)
•Subject has experienced at least 2 unprovoked seizures in the year preceding randomization, of which at least 1 unprovoked seizure occurred in the 3 months preceding randomization
•Subject has had an Electroencephalogram (EEG) and a brain Computed Tomography (CT) scan or brain Magnetic Resonance Imaging (MRI) scan consistent with a diagnosis of Epilepsy with POS
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 36
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 380
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•Subject tests positive for human leukocyte antigen major histocompatibility complex, class I,B (HLA-B)* 1502 allele
•Subject has a history or presence of seizures of other types than Partial-Onset Seizures (POS)
•Subject has only experienced type IA nonmotor seizures
•Subject has a history or presence of seizures occurring only in clustered patterns
•Subject has a history of clinical or Electroencephalogram (EEG) findings suggestive of Idiopathic Generalized Epilepsy prior to randomization
•Subject has current or previous diagnosis of pseudoseizures, conversion disorders, or other nonepileptic ictal events that could be confused with seizures
•Subject has a history of Status Epilepticus

发起方

CB Pharma SA