NCT00150774已完成3 期
A Double-blind, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Levetiracetam (LEV) (Oral Tablets of 500 mg b.i.d.) at a Dose of 3000 mg/Day as Adjunctive Treatment in Adolescents (≥ 12 Years) and Adults (≤ 65 Years) Suffering From Idiopathic Generalized Epilepsy With Myoclonic 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
- 116
- 主要终点
- Responder rate in myoclonic (type IIB) seizures days over 16 weeks
研究概览
简要总结
A double-blind, placebo-controlled study to assess the efficacy of adjunctive treatment with LEV 3000mg/day in reducing myoclonic seizures in adolescents and adults suffering from idiopathic generalised epilepsy and to evaluate the safety of LEV in the same population.
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
- Double
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a confirmed diagnosis consistent with idiopathic generalized epilepsy experiencing myoclonic seizures (IIB) that are classifiable according to the International Classification of Epileptic Seizures. To ensure an idiopathic generalized epilepsy population, only these subjects with the diagnosis of juvenile myoclonic epilepsy (JME), juvenile absence epilepsy (JAE) or epilepsy with generalized tonic- clonic seizures on awakening must be included.
- •Presence of at least eight days with at least one myoclonic seizure (IIB) per day during the eight weeks of the Baseline period.
- •Absence of brain lesion documented on a CT scan or MRI; if a CT scan or MRI has not been performed within the past five years before Visit 1, a CT scan (or MRI where legally required) should be performed during the Baseline period.
- •Presence of EEG features consistent with idiopathic generalized epilepsy on an EEG recorded during the Baseline period or no more than one year before Visit
- •Male/female children ≥ 12 years of age or adult ≤ 65 years of age at Visit
- •Subject on a stable dose of one standard anti-epileptic treatment for at least four weeks before Visit 1.
排除标准
- •Previous exposure to levetiracetam.
- •History of partial seizures.
- •History of convulsive or non-convulsive status epilepticus within 3 months prior to Visit
- •Subject taking vigabatrin or tiagabine, subject on felbamate with less than 18 months exposure, and subject under vagal nerve stimulation or ketogenic diet.
- •Subject taking any drug (except the concomitant AEDs) with possible CNS effects.
结局指标
主要结局
Responder rate in myoclonic (type IIB) seizures days over 16 weeks
次要结局
- Safety and tolerability of levetiracetam by means of AE, laboratory assessments, plasma concentration
研究者
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