Childhood Absence Epilepsy: Coordinating Center

儿童失神癫痫：协调中心

• 批准号: 6805853
• 负责人: AVITAL CNAAN
• 金额: $ 82.26万
• 依托单位: CHILDREN'S HOSP OF PHILADELPHIA
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-30 至 2008-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6805853
• 关键词: adolescence (12-20); anticonvulsants; biomedical facility; clinical research; clinical trials; cooperative study; data collection; data management; data quality /integrity; drug screening /evaluation; generalized seizures; human data; middle childhood (6-11); patient oriented research; preschool child (1-5); statistics /biometry

DESCRIPTION (provided by the applicant): Treatment for Childhood Absence Epilepsy (CAE) is largely empiric. Although there are three efficacious antiepileptic drugs (AEDs) - ethosuximide (ETX), lamotrigine (LTG), valproic acid (VPA) - each has variable success in seizure control, as well as treatment-limiting toxicities. This project is being resubmitted as two linked R01 applications. The clinical proposal, "Childhood Absence Epilepsy - Rx, PK/PK, Genetics," (PI: T. Glauser, Co-PI: P. Adamson) is being resubmitted by the Cincinnati Children's Hospital. The objectives of the clinical trial are twofold: a) identify the optimal initial AED in terms of seizure control and lowest toxicity incidence; and b) to determine the clinical, pharmacokinetic and pharmacogenetic factors underlying the inter-individual variation in AED response and toxicity. This linked R01 proposal will establish the Childhood Absence Epilepsy Coordinating Center [CHAECC] at The Children's Hospital of Philadelphia to support this broad, integrated plan to study CAE. A strong and efficient coordinating center is needed in a project of this magnitude and complexity to ensure that the scientific goals are achieved in a timely manner and to a high standard of scientific excellence and data integrity as well as subject safety. The Children's Hospital of Philadelphia (CHOP) has established a highly experienced team to provide this coordinating center function. The aims of the CHAECC are to provide: 1) operational support to implement the protocol; 2) data base and data management for the protocol and the Core's data; 3) biostatistical analyses of the project aims. To meet these goals, the CHAECC will perform start-up activities to implement the project, coordinate all communication activities, oversee adherence to Good Clinical Practice and HIPPA guidelines in protocol implementation, and will work closely with the Scientific Leadership of the study. The CHAECC will develop procedures for data collection, transference, and storage in a secure relational database. The CHAECC will coordinate receipt of video EEG's by Core readers and meetings to achieve consensus in interpretations. It will conduct all statistical analyses and support preparation of reports, manuscripts and presentations.

描述（由申请人提供）：儿童缺勤癫痫（CAE）的治疗在很大程度上是经验性的。尽管有三种有效的抗癫痫药（AEDS） - 乙糖胺（ETX），拉莫三嗪（LTG），丙戊酸（VPA） - 每种都在癫痫发作控制方面取得了可变的成功，以及治疗限制性毒性。该项目正在作为两个链接的R01应用程序重新提交。临床建议是“儿童缺席癫痫-RX，PK/PK，遗传学”（PI：T。Glauser，Co -Pi：P。Adamson）正在由辛辛那提儿童医院重新提交。临床试验的目标是双重的：a）从癫痫发作和最低毒性发生率方面确定最佳初始AED； b）确定AED反应和毒性中个体间变异的基础的临床，药代动力学和药物遗传因素。该链接的R01提案将在费城儿童医院建立儿童缺席癫痫协调中心[CHAECC]，以支持这一广泛的，综合的计划研究CAE。在这个大小和复杂性的项目中，需要一个强大而有效的协调中心，以确保及时实现科学目标，并在高标准的科学卓越和数据完整性以及主题安全方面实现。费城儿童医院（CHOP）建立了一支经验丰富的团队，以提供这一协调的中心职能。 CHAECC的目的是提供：1）实施协议的操作支持； 2）协议和核心数据的数据库和数据管理； 3）该项目的生物统计分析。 为了实现这些目标，CHAECC将执行启动活动以实施该项目，协调所有沟通活动，监督对良好的临床实践的遵守以及HIPPA在协议实施中的指南，并将与研究的科学领导力紧密合作。 CHAECC将在安全的关系数据库中开发用于数据收集，转移和存储的过程。 CHAECC将通过核心读者和会议协调视频脑电图的接收，以在解释中达成共识。它将进行所有统计分析和支持准备报告，手稿和演示文稿的准备。