NCT00160550已完成3 期
A Double-blind, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Treatment With 3000 mg/Day (Pediatric Target Dose of 60 mg/kg/Day) Oral Levetiracetam (LEV) (166, 250, and 500mg Tablets), in Adult and Pediatric Subjects (4-65 Years) Suffering From Idiopathic Generalized Epilepsy With Primary Generalized Tonic-clonic (PGTC) Seizures.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 154
- 主要终点
- The percentage reduction from the combined Baseline Period in the PGTC seizure frequency per week over the Treatment Period (up-titration + evaluation).
研究概览
简要总结
This study will assess the efficacy, safety, and tolerability of adjunctive treatment with LEV (3,000 mg/day or a target dose of 60 mg/kg/day in children) compared to placebo in reducing PGTC seizures in subjects (4 - 65 years) suffering from idiopathic generalized epilepsy uncontrolled despite treatment with one or two concomitant AEDs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 4 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with a confirmed diagnosis consistent with idiopathic generalized epilepsy experiencing primary generalized tonic-clonic seizures (IIE) that are classifiable according to the ILAE Classification of Epileptic Seizures.
- •Presence of at least 3 PGTC seizures during the 8-week combined Baseline period.
- •Absence of brain lesion documented on a CT scan or MRI.
- •An EEG performed within 1 year of Visit 1 with features consistent with PGTC seizures or generalized idiopathic epilepsy.
- •Male/female subject, >=4 or <=65 years of age at Visit
- •Subject on a stable dose of one or two AEDs during baseline.
排除标准
- •Previous exposure to levetiracetam.
- •History of partial seizures.
- •History of convulsive or non-convulsive status epilepticus while taking concomitant AEDs within three months prior to Visit 1.
结局指标
主要结局
The percentage reduction from the combined Baseline Period in the PGTC seizure frequency per week over the Treatment Period (up-titration + evaluation).
次要结局
- Reduction during the Treatment Period in PGTC seizure frequency
- Percentage reduction during the Treatment Period in seizure days
- Responder rates in PGTC seizure frequency, and in seizure days of all types.
- The safety parameters are the following: Laboratory tests; Adverse events; Electrocardiogram; Physical and neurological examinations
研究者
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