Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 154
- 主要终点
- Partial (Type I) Seizure Frequency Per Week by Analysis Visit
研究概览
简要总结
The safety and efficacy of L059 was evaluated in patients who completed "N165 Clinical Trial of L059". They received L059 at a daily dose from 1,000 mg to 3,000 mg in addition to their standard concomitant AEDs
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Patients who completed the evaluation period (Week 16) of N165 Clinical Trial of L059
- •Patients/the parent or guardian wish to continue treatment with L059 and to enter N165 Follow-up Study, and also the investigator admit the necessity of the repeated intake of the investigational drug for the patients.
排除标准
- •Patients who had not participate in N165 Clinical Trial of L
- •Patients who had participated in N165 Clinical Trial of L059 with no intention of entering the follow-up study taking the same medication.
- •Patients had not been in compliance with requirements of Protocol for N165 Clinical Trial of L059 in the course of the study.
研究组 & 干预措施
Levetiracetam
Subjects received oral tablets of Levetiracetam. This study N01020 (NCT00160615) was designed as a single group assignment study and as follow-up study, open for patients from N165 (NCT00600509). The differentiation into placebo and Levetiracetam in the results reporting section is based on the treatment of the previously conducted study N165 (NCT00600509).
干预措施: Levetiracetam (Drug)
结局指标
主要结局
Partial (Type I) Seizure Frequency Per Week by Analysis Visit
时间窗: From Baseline up to 54 months
Number of Partial (Type I) seizures over the treatment period standardized to 1 week period.
Partial (Type IA) Seizure Frequency Per Week by Analysis Visit
时间窗: From Baseline up to 54 months
Number of Partial (Type IA) seizures over the treatment period standardized to 1 week period.
Partial (Type IB) Seizure Frequency Per Week by Analysis Visit
时间窗: From Baseline up to 54 months
Number of Partial (Type IB) seizures over the treatment period standardized to 1 week period.
Partial (Type IC) Seizure Frequency Per Week by Analysis Visit
时间窗: From Baseline up to 54 months
Number of Partial (Type IC) seizures over the treatment period standardized to 1 week period.
次要结局
- Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit(From Baseline up to 54 months)
- Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit(From Baseline up to 54 months)
- Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit(From Baseline up to 54 months)
- Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit(From Baseline up to 54 months)