An Open-label, Multicenter, Follow-up Study to Evaluate the Safety and Efficacy of Levetiracetam (LEV) (Oral Tablets of 166, 250 or 500 mg b.i.d.), at Individualized Doses up to a Maximum of 4000 mg/Day (or 80 mg/kg/Day for Children and Adolescents Less Than 50 kg), in Children (≥ 4 Years Old), Adolescents and Adults Suffering From Primary Generalized Seizures
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 217
- 主要终点
- Number of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period
研究概览
简要总结
An open-label, follow-up study to evaluate the safety and efficacy of levetiracetam (LEV), in children (≥ 4 years old), adolescents and adults suffering from primary generalized seizures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female children, adolescents and adults having completed the final visit of a previous study with levetiracetam (LEV)
- •Subjects who were/are suffering from primary generalized (type II) epileptic seizures
- •Subjects for whom the Investigator believes a reasonable benefit (efficacy or tolerability) from the long-term administration of LEV may be expected
排除标准
- •Known clinically significant acute or chronic illness, for example: cardiac, renal or hepatic dysfunction, etc., which may impair reliable participation in the trial or necessitate the use of medication not allowed by protocol
- •Concomitant use of any drug with possible central nervous system effects unless at a stable dose
- •Concomitant use of any drug (other than hormonal treatment and the subject's normal anti-epileptic drugs (AEDs) that may influence the metabolism of the concomitant AED(s), except if the dose has been stable before entry in the study for sufficient length of time
研究组 & 干预措施
Levetiracetam
Subjects received treatment up to 1764 days during the Evaluation Period. Up to 4000 mg/day (or 80 mg/kg/day for children and adolescents less than 50 kg). Oral tablets of 166, 250, or 500 mg Levetiracetam twice daily (b.i.d.).
干预措施: Levetiracetam 166 mg (Drug)
Levetiracetam
Subjects received treatment up to 1764 days during the Evaluation Period. Up to 4000 mg/day (or 80 mg/kg/day for children and adolescents less than 50 kg). Oral tablets of 166, 250, or 500 mg Levetiracetam twice daily (b.i.d.).
干预措施: Levetiracetam 250 mg (Drug)
Levetiracetam
Subjects received treatment up to 1764 days during the Evaluation Period. Up to 4000 mg/day (or 80 mg/kg/day for children and adolescents less than 50 kg). Oral tablets of 166, 250, or 500 mg Levetiracetam twice daily (b.i.d.).
干预措施: Levetiracetam 500 mg (Drug)
结局指标
主要结局
Number of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period
时间窗: Evaluation Period
Percentage of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period
时间窗: Evaluation Period
次要结局
- Number of subjects remaining seizure-free, for the All intent-to-treat (ITT) population, and Tonic-Clonic, Myoclonic, and Absence subpopulations since the beginning of this study N167 (Visit 1) during the Evaluation Period(From Visit 1 to the end of the Evaluation Period)
- Percentage of subjects remaining seizure-free, for the All intent-to-treat (ITT) population, and Tonic-Clonic, Myoclonic, and Absence subpopulations since the beginning of this study N167 (Visit 1) during the Evaluation Period(From Visit 1 to the end of the Evaluation Period)
- Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types(From N01057 or N166 Baseline to the Evaluation Period)
- Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations(From N01057 or N166 Baseline to the Evaluation Period)
- Categorical percentage reduction from Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations(Evaluation Period)
- Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types(From N01057 or N166 Baseline to the Evaluation Period)
- Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations(From N01057 or N166 Baseline to the Evaluation Period)
- Categorical percentage reduction from Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types(Evaluation Period)