A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures
An Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of Adjunctive Treatment With Levetiracetam in Japanese Patients (≥4 to <16 Years) With Uncontrolled Generalized Tonic-clonic (GTC) Seizures Despite Treatment With 1 or 2 Antiepileptic Drug(s)
研究概览
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Akita、日本
- 191
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Bunkyo、日本
- 184
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Bunkyo、日本
- 309
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Gifu、日本
- 107
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Hiroshima、日本
- 303
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Kobe、日本
- 108
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Kodaira、日本
- 302
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Koshi、日本
- 306
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Moriyama、日本
- 136
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Nagoya、日本
- 305
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Nerima、日本
- 190
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Neyagawa、日本
- 125
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Niigata、日本
- 301
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Ohmura、日本
- 116
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Okayama、日本
- 109
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Onojo、日本
- 308
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Saitama、日本
- 119
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Sapporo、日本
- 117
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Sapporo、日本
- 304
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Sendai、日本
- 103
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Shimotsuke、日本
- 138
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Shizuoka、日本
- 307
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Takatsuki、日本
- 139
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Tsu、日本
- 135
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Yokohama、日本
- 193
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Yufu、日本
- 310
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- An epileptic patient with generalized tonic-clonic seizures that are classifiable according to the International League Against Epilepsy classification of epileptic seizures (Epilepsia, 1981)
- A patient on a stable dose of 1 or 2 anti-epileptic drugs for the last 4 weeks (potassium bromide and sodium bromide for the last 12 weeks) prior to the Combined Baseline Period and during the Combined Baseline Period
Exclusion Criteria:
- Presence of any sign (clinical or imaging procedures) suggesting a progressive brain lesion/disease, in particular, progressive disorder with epileptic seizures
- Diagnosis of Lennox-Gastaut Syndrome
- Confirmed focal epilepsy based on clinical signs (seizure types), with consistent electroencephalogram and magnetic resonance imaging features
- A history of convulsive or nonconvulsive status epilepticus while taking concomitant anti-epileptic drugs for the last 3 months prior to Visit 1
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：左乙拉西坦
每天两次（早晚）口服
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The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks.
After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The Percent Change From the Combined Baseline (4-week Retrospective Baseline and 4-week Prospective Baseline) in the Generalized Tonic-clonic Seizure Frequency Per Week Over the 24-week Treatment Period (Up-Titration and Evaluation Periods)
大体时间：From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)
|
The percent change from Combined Baseline over Treatment Period was calculated from the Generalized Tonic-Clonic (GTC) seizure frequency per week during the Treatment Period (T) and during the Baseline Period (B, Combined Baseline, ie, Retrospective and Prospective Baseline Periods) using the equation below. The percent change from Baseline = (B - T)/B x 100 The seizure frequency per week was calculated using the following formula: Frequency per week of GTC seizures = total number of GTC seizures in the corresponding period / number of days for observation in the corresponding period x 7 |
From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The Percent Change in Generalized Tonic-clonic Seizure Frequency Per Week From the Combined Baseline Period Over the Evaluation Period
大体时间：From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)
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The percent change from Combined Baseline over Evaluation Period was calculated from the Generalized Tonic-Clonic (GTC) seizure frequency per week during the Evaluation Period (E) and during the Baseline Period (B, Combined Baseline, ie, Retrospective and Prospective Baseline Periods) using the equation below. The percent change from Baseline = (B - E)/B x 100 The seizure frequency per week was calculated using the following formula: Frequency per week of GTC seizures = total number of GTC seizures in the corresponding period / number of days for observation in the corresponding period x 7 |
From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)
|
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Generalized Tonic-clonic Seizures 50 % Responder Rate (the Proportion of Subjects With 50 % or More Reduction From the Combined Baseline in the Frequency of Generalized Tonic-clonic Seizures) During the Treatment Period
大体时间：From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)
|
The 50 % responder rate during the Treatment Period was the proportion of subjects who reported a ≥ 50 % reduction in seizure frequency per week from Baseline during the Treatment Period.
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From Baseline (Week -8) to Treatment Period (Week 0 to Week 24)
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Generalized Tonic-clonic Seizures 50 % Responder Rate During the Evaluation Period
大体时间：From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)
|
The 50 % responder rate during the Evaluation Period was the proportion of subjects who reported a ≥50 % reduction in seizure frequency per week from Baseline during the Evaluation Period.
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From Baseline (Week -8) to Evaluation Period (Week 4 to Week 24)
|
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Generalized Tonic-clonic Seizure Freedom Over the Treatment Period
大体时间：Treatment Period (Week 0 to Week 24)
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A subject with a generalized tonic-clonic seizure frequency of 0 per week throughout the Treatment Period was considered a seizure-free subject for that period.
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Treatment Period (Week 0 to Week 24)
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Generalized Tonic-clonic Seizure Freedom Over the Evaluation Period
大体时间：Evaluation Period (Week 4 to Week 24)
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A subject with a generalized tonic-clonic seizure frequency of 0 per week throughout the Evaluation Period was considered a seizure-free subject for that period.
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Evaluation Period (Week 4 to Week 24)
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.