An add-on Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-epileptic Drugs (AEDs)
2013年1月3日 更新者：Eisai Co., Ltd.
A Phase II, Open-label, Ascending High-dose, add-on Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-epileptic Drugs (AEDs)
The purpose of this study is to explore the maximum tolerated dose of E2007 in Japanese patients with refractory partial seizures which are uncontrolled with other anti-epileptic drugs (AEDs).
Thirty patients will receive E2007 (dose escalating to the maximum of 12 mg per day).
The dose of E2007 will be adjusted during 6 weeks.
Subsequently, the dose will be fixed and maintained during 4 weeks.
研究概览
研究类型
介入性
注册 (实际的)
30
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Kyoto、日本
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Nagasaki、日本
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Niigata、日本
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Shizuoka、日本
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Fukuoka
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Kitakyushu、Fukuoka、日本
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Hyogo
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Kobe、Hyogo、日本
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Miyagi
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Sendai、Miyagi、日本
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Tokushima
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Komatsushima、Tokushima、日本
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Tokyo
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Kodaira、Tokyo、日本
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 64年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion criteria:
- Male or female aged between 20 and 64 years old.
- Patients diagnosed with partial seizure (including secondarily generalized seizure).
- Patients who have at least 3 counts of partial seizures during the previous 4 weeks prior to observation start and no seizure-free for 21 days during 8 weeks before the treatment start based on medical records. Simple partial seizure without motor signs will not be counted.
- Patients who have been treated for at least 12 weeks but confirmed to be uncontrolled with more than one standard AED for 2 years.
Patients treated with stable doses of up to three AEDs. Only one cytochrome
P450 (CYP) 3A4 inducer shown below will be allowed for concomitant use:
- Carbamazepine
- Phenytoin
- Phenobarbital
- Primidone
- Patients on stable dose of anti-depressants, anti-anxiety drugs, or mood stabilizers from before 8 weeks.
Exclusion criteria:
- Patients with present or a history of Lennox-Gastaut syndrome.
- Patients with present generalized seizures (e.g., absence, myoclonic).
- Patients with a history of status epilepticus within 1 year.
- Patients with seizure clusters where individual seizure cannot be counted within 8 weeks.
- Patients with a history of psychogenic seizure.
- Patients who underwent surgical operation for epilepsy within 2 years.
- Patients using rescue benzodiazepines at least twice in a 4-week duration within 8 weeks (if 1 or 2 doses over 24-hour period considered one-time rescue).
- Patients whose alanine aminotransferase (ALT) or aspartate aminotransferase (AST) at enrollment in observation period exceeds 1.5-fold the upper limit of normal (ULN), but those whose ALT or AST are constantly higher than ULN, they can enroll if ALT or AST remain in 3-fold the ULN.
- Patients with significant active hematological disease; white blood cell (WBC) count </=2500/uL or neutrophil count </=1000 uL.
- Patients on anti-psychotics or who have psychotic disorder and/or psychotic disorder(s) or unstable recurrent affective disorder(s) with a history of suicidal attempt within 2 years.
- Patients who operate heavy equipment or drive should not be recruited into the study.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 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 |
|---|---|
|
实验性的：1个
|
The dose of E2007 will start from 2 mg and will be increased by 2 mg every week up to 12 mg (the maximum dose).
The dose will be adjusted during 6 weeks (i.e., titration period).
Subsequently, the dose will be fixed and maintained during 4 weeks (Maintenance period).
Patients must visit study site at Weeks -4, 1, 2, 3, 4, 5, 6, 8, 10 and 14 to confirm.
|
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 |
|---|---|---|
|
Maximum Tolerated Dose (MTD)
大体时间：10 weeks (Titration and Maintenance Periods)
|
MTD was defined by participants.
For participants who completed treatment, MTD was dose at last administration.
For subjects who discontinued due to adverse event (AE), the MTD depended on the number of days within down-titration.
If these criteria were not applied, the MTD was determined based on suggestions from the Tolerability and Safety Evaluation Committee.
|
10 weeks (Titration and Maintenance Periods)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percent Change in Total Seizure Frequency Per 28 Days From Baseline (Maintenance Period) ; LOCF
大体时间：Baseline (Day -28 to Day 0), Week 1 to Week 10
|
The percent change in seizure frequency per 28 days during the maintenance period was collected via patient diary cards.
This was calculated using the last observation carried forward (LOCF) method.
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Baseline (Day -28 to Day 0), Week 1 to Week 10
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Hidetaka Hiramatsu、New Drug Development Department, Eisai Company Limited
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年4月1日
初级完成 (实际的)
2009年11月1日
研究完成 (实际的)
2009年11月1日
研究注册日期
首次提交
2009年2月20日
首先提交符合 QC 标准的
2009年2月20日
首次发布 (估计)
2009年2月23日
研究记录更新
最后更新发布 (估计)
2013年2月7日
上次提交的符合 QC 标准的更新
2013年1月3日
最后验证
2013年1月1日
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.