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Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures

2013年2月8日 更新者：UCB Pharma

A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures.

To allow pediatric patients with partial onset seizures an opportunity to receive (as follow-up to studies N01009(NCT00105040)/N01103(NCT00175890) or by direct enrollment) open-label levetiracetam treatment, continue studying cognition and behavior in children, and continue collection of safety/efficacy data.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

255

阶段

  • 第三阶段

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

  • 俄罗斯联邦
      • Kalingrad、俄罗斯联邦
      • Moscow、俄罗斯联邦
      • St Petersburg、俄罗斯联邦
      • St. Petersburg、俄罗斯联邦
  • 加拿大
    • British Columbia
      • Vancouver、British Columbia、加拿大
    • Ontario
      • Thornhill、Ontario、加拿大
      • Toronto、Ontario、加拿大
  • 匈牙利
      • Budapest、匈牙利
  • 南非
      • Cape Town、南非
      • Capitol Park、南非
      • Johannesburg、南非
  • 印度
      • Hyderabad、印度
      • Lucknow、印度
      • Mahim Mumbai、印度
      • Mumbai、印度
      • Pune Maharashtra、印度
  • 墨西哥
      • Mexico City、墨西哥
  • 巴西
      • Campinas、巴西
      • Curitiba、巴西
      • Porto Alegre、巴西
      • Ribeirao Preto、巴西
      • Rio de Janeiro、巴西
      • Sao Paulo、巴西
  • 德国
      • Berlin、德国
      • Erlangen、德国
      • Heidelberg、德国
      • Jena、德国
      • Kiel、德国
    • Kork
      • Kehl、Kork、德国
  • 意大利
      • Calambrone、意大利
      • Genoa、意大利
      • Milano、意大利
      • Roma、意大利
  • 捷克共和国
      • Brno、捷克共和国
      • Praha 4、捷克共和国
  • 比利时
      • Brussels、比利时
      • Leuven、比利时
  • 法国
      • Lille Cedex、法国
      • Paris、法国
      • Strasbourg Cedex、法国
  • 波兰
      • Gdansk、波兰
  • 罗马尼亚
      • Bucharest、罗马尼亚
      • Cluj-Napoca、罗马尼亚
      • Tirgu-Mures、罗马尼亚
  • 美国
    • Alabama
      • Mobile、Alabama、美国
    • Arizona
      • Phoenix、Arizona、美国
    • California
      • Los Angeles、California、美国
    • Colorado
      • Denver、Colorado、美国
    • District of Columbia
      • Washington、District of Columbia、美国
    • Florida
      • Bradenton、Florida、美国
      • Loxahatchee、Florida、美国
      • Orlando、Florida、美国
      • Pensacola、Florida、美国
      • Tallahassee、Florida、美国
      • Tampa、Florida、美国
    • Georgia
      • Atlanta、Georgia、美国
      • Augusta、Georgia、美国
    • Illinois
      • Chicago、Illinois、美国
    • Louisiana
      • New Orleans、Louisiana、美国
    • Massachusetts
      • Boston、Massachusetts、美国
    • Minnesota
      • St. Paul、Minnesota、美国
    • New Hampshire
      • Lebanon、New Hampshire、美国
    • New Jersey
      • Edison、New Jersey、美国
      • Voorhees、New Jersey、美国
    • New York
      • Buffalo、New York、美国
      • New York、New York、美国
      • Rochester、New York、美国
      • Syracuse、New York、美国
    • North Carolina
      • Chapel Hill、North Carolina、美国
    • Ohio
      • Cleveland、Ohio、美国
    • Pennsylvania
      • Hershey、Pennsylvania、美国
      • Philadelphia、Pennsylvania、美国
    • South Carolina
      • Charleston、South Carolina、美国
    • Tennessee
      • Germantown、Tennessee、美国
      • Nashville、Tennessee、美国
    • Texas
      • Fort Worth、Texas、美国
      • Galveston、Texas、美国
    • Utah
      • Salt Lake City、Utah、美国
    • Virginia
      • Norfolk、Virginia、美国
      • Richmond、Virginia、美国
    • West Virginia
      • Morgantown、West Virginia、美国
    • Wisconsin
      • Milwaukee、Wisconsin、美国
  • 英国
      • Bristol、英国
      • Cardiff、英国
      • London、英国

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

1个月 至 16年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Pediatric patients with partial onset seizures, with 1 to 2 anti-epileptic drugs (AEDS), with participation in previous levetiracetam pediatric studies (N01009 or N01103) or direct enrollment, for whom levetiracetam treatment will be of possible benefit

Exclusion Criteria:

  • Patients on a ketogenic diet
  • Seizures too close together to accurately count
  • Pseudoseizures
  • Status epilepticus 1 month prior Visit 1
  • Current diagnosis of Lennox-Gastaut Syndrome or epilepsy secondary to a progressing cerebral disease will be excluded from 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：左乙拉西坦
药品：levetiracetam (LEV)
Per protocol oral tablets or oral solution at 10 to 30mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
其他名称：
  • 吉普拉

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
Percentage Change (Reduction) of Partial (Type I) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.
大体时间：Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)

次要结果测量

结果测量
措施说明
大体时间
Percentage Change (Reduction) of Total (Type I, II, III) Seizure Frequency Per Week From Baseline Over Time During Treatment Period.
大体时间：Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period.
大体时间：Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period.
大体时间：Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Change (Reduction) From Baseline in Partial (Type I) Seizure Frequency Per Week Over Time During Treatment Period
大体时间：Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Change (Reduction) From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During Treatment Period
大体时间：Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Positive changes from Baseline indicate an improvement (i.e., a reduction) in seizure frequency per week.
Up-titration/Conversion Period (2-8 weeks); Maintenance Period (2-8 weeks to 40-46 weeks)
Partial Seizure (Type I) Responder Rate (Percent) During the Up-titration/Conversion Phase and by Visit During the Maintenance Phase
大体时间：Up-titration (4 weeks); Maintenance Visits 3-4 (weeks 4-14, 6-15, or 8-16); Visits 4-5 (weeks 14-24, 15-24, or 16-24); Visits 5-6 (weeks 24-36); Visits 6-7 (weeks 36-48)

The responder rate is defined as the number of responders. A responder is a patient with a 50% or greater change (reduction) in partial seizure frequency per week.

Note: Rates were reported as percentages.
Up-titration (4 weeks); Maintenance Visits 3-4 (weeks 4-14, 6-15, or 8-16); Visits 4-5 (weeks 14-24, 15-24, or 16-24); Visits 5-6 (weeks 24-36); Visits 6-7 (weeks 36-48)
Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
大体时间：Subjects with up to 24 weeks of exposure
For subjects with up to 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.
Subjects with up to 24 weeks of exposure
Partial Seizure (Type I) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
大体时间：Subjects with greater than 24 weeks of exposure
For subjects with greater than 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.
Subjects with greater than 24 weeks of exposure
Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
大体时间：Subjects with up to 24 weeks of exposure
For subjects with up to 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.
Subjects with up to 24 weeks of exposure
Total Seizure (Type I, II, III) Maximum Seizure Free Interval (Percentage of Days Belonging to a Seizure Free Interval of 28 Days or More)
大体时间：Subjects with greater than 24 weeks of exposure
For subjects with greater than 24 weeks in the evaluation phase the denominator for each subject is their number of days in the evaluation phase.
Subjects with greater than 24 weeks of exposure
Total Seizure (Type I, II, III) Continuously Seizure Free During the Maintenance Period
大体时间：greater than or equal to 24 weeks, greater than or equal to 40 weeks

The measure description is the product limit adjusted percent of subjects seizure free starting from the beginning of the Maintenance Period.

The up-titration period is the up to 6 week period of increasing dose prior to the Maintenance Period. The Maintenance Period is the period of stable dosing, subsquent to the up-titration period, which could last from 42 to 48 weeks.
greater than or equal to 24 weeks, greater than or equal to 40 weeks
Percent of Subjects With Each Seizure Type During the Evaluation Period
大体时间：Evaluation period (48 weeks)

Type I Seizure is a partial onset Seizure (see International League Against Epilepsy definitions).

Type II Seizure is a Generalized Seizure (see International League Against Epilepsy definitions).

Type III Seizure is a Unknown Seizure Type (see International League Against Epilepsy definitions).

A subject could experience more than one seizure type.
Evaluation period (48 weeks)
Investigator Global Evaluation Scale
大体时间：End of Evaluation period (week 48 or at point of early discontinuation)
There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).
End of Evaluation period (week 48 or at point of early discontinuation)
Parent/Guardian Global Evaluation Scale
大体时间：End of Evaluation period (week 48 or at point of early discontinuation)
There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).
End of Evaluation period (week 48 or at point of early discontinuation)
Subject (>=8 Years Old) Global Evaluation Scale
大体时间：End of Evaluation period (week 48 or at point of early discontinuation)
There are 7 categories, 3 for improvement (Marked improvement, Moderate improvement, Slight improvement), 3 for worsening (Slight worsening, Moderate worsening, Marked worsening), and 1 for no change (No change).
End of Evaluation period (week 48 or at point of early discontinuation)
Leiter-R Associated Memory (AM) Memory Screen Composite Score Change From Baseline to Visit 5 (Week 24) and Visit 7 (Week 48) (4 to 16 Year Olds)
大体时间：Baseline to Visit 5 (Week 24) and Visit 7 (Week 48)
The Leiter-R AM battery has 10 subtests. The raw scores of the subtests are converted into scaled scores. Six composite scores are constructed from the 10 subtest scaled scores. The Memory Screen is one of them. It is composed of 2 subtests the Associated Pairs and Forward Memory. The sum of the Associated Pairs and Forward Memory subtest scaled scores are converted into a Memory composite score normally distributed with a mean and standard deviation of 100 (±15). Higher scores and positive changes from baseline are better. The range of the Memory Screen composite score is 44 to 155.
Baseline to Visit 5 (Week 24) and Visit 7 (Week 48)
Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Olds)
大体时间：Visit 5 (Week 24)
This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.
Visit 5 (Week 24)
Bayley Scale of Infant Development (BSID) II Mental Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Olds)
大体时间：Visit 7 (week 48)
This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.
Visit 7 (week 48)
Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 5 (Week 24) (1 Month to < 4 Year Old)
大体时间：Visit 5 (week 24)
This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.
Visit 5 (week 24)
Bayley Scale of Infant Development (BSID) II Psychomotor Development Index Scores Classification Shift From Baseline at Visit 7 (Week 48) (1 Month to < 4 Year Old)
大体时间：Visit 7 (week 48)
This score is obtained from a total raw score which is the sum of a battery of individual questions. It is adjusted for a child's age, has an expected mean of 100 and standard deviation of 15, and can be categorized as: (1) Accelerated Performance (>= 115), (2) Within Normal Limits (85-114), (3) Mildly Delayed Performance (70-84), and (4) Significantly Delayed Performance (<=69). Changes from baseline are then further categorized where 'Improved' is any positive category change, 'Stable' is no category change, and 'Worsened' is any negative category change, from baseline.
Visit 7 (week 48)

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。

赞助

UCB Pharma

调查人员

  • 研究主任：UCB Clinical Trial Call Center、+1 877 822 9493

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。

一般刊物

有用的网址

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

2004年10月1日

初级完成 (实际的)

2008年6月1日

研究完成 (实际的)

2008年6月1日

研究注册日期

首次提交

2005年9月7日

首先提交符合 QC 标准的

2005年9月7日

首次发布 (估计)

2005年9月9日

研究记录更新

最后更新发布 (估计)

2013年2月12日

上次提交的符合 QC 标准的更新

2013年2月8日

最后验证

2010年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • N01148
  • EudraCT number:2004-000200-40

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.

癫痫，部分的临床试验

levetiracetam (LEV)的临床试验

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赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Djibouti

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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