NCT01954121已完成3 期
An Open-label, Randomized, Parallel-group, Active-controlled Study Comparing the Efficacy and Safety of Levetiracetam to Carbamazepine Used as Monotherapy in Subjects Newly or Recently Diagnosed as Epilepsy and Partial-onset Seizures
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 436
- 试验地点
- 28
- 主要终点
- Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period
研究概览
简要总结
To demonstrate the non-inferiority of Levetiracetam (1000 mg/day) versus Carbamazepine Immediate-Release (400 mg/day) used as monotherapy for at least 6 months in a Chinese population with newly or recently diagnosed Epilepsy who are experiencing Partial-Onset Seizures (POS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Levetiracetam
Experimental
Levetiracetam 1000 mg/day
干预措施: Levetiracetam (Drug)
Carbamazepine
Active Comparator
Carbamazepine 400 mg/day
干预措施: Carbamazepine (Drug)
结局指标
主要结局
Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period
时间窗: 6-months Evaluation Period (From Week 4 to Week 30)
次要结局
- Proportion of Subjects Retained in the Study for the Duration of the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period(From Week 1 to Week 30)
- Time to First Seizure or Discontinuation Due to an Adverse Event (AE) / Lack of Efficacy (LOE) During the Evaluation Period(From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30))
- Time to First Seizure During the Evaluation Period(From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30))
- Time to First Seizure During the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period From the First Dose of Study Drug(From Randomization (Week 1) up to Evaluation Visit (Week 30))
研究者
研究点 (28)
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