The Epilepsy Bioinformatics Study for Antiepileptogenic Therapy (EpiBioS4Rx)

抗癫痫治疗的癫痫生物信息学研究 (EpiBioS4Rx)

基本信息

批准号：
10161189
负责人：
JEROME NONE ENGEL
金额：
$ 3.75万
依托单位：
UNIVERSITY OF SOUTHERN CALIFORNIA
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-05-08 至 2020-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10161189
关键词：
Address Animal Model Animals Antiepileptogenic Area Bioinformatics Biological Markers Brain Injuries Clinical Clinical Research Clinical Trials Collaborations Communities Consumer Organizations Databases Development Diagnosis Drug usage Education Effectiveness Electrophysiology (science)Epilepsy Epileptogenesis Funding Future Grant Human Image Injury Institution International Intervention Investigation Lateral Lead Measures Methodology Modeling Multicenter Trials Patients Performance Pharmaceutical Preparations Plasma Post-Traumatic Epilepsy Prevention therapy Process Protocols documentation Randomized Rattus Research Research Project Grants Resources Sensitivity and Specificity Severities Standardization TBI Patients Techniques Time Traumatic Brain Injury Work base biobank biomarker panel biomarker performance clinical investigation cost effective design experience fluid percussion injury multidisciplinary multimodality nondrug therapy novel patient population personalized medicine pre-clinical preclinical study preclinical trial prevent preventable epilepsy programs recruit research clinical testing response targeted biomarker tool translational study

项目摘要

PROJECT SUMMARY – EPIBIOS4RX OVERALL The Epilepsy Bioinformatics Study for Antiepileptogenic Therapy (EpiBioS4Rx), a CWOW proposal in response to RFA-NS-16-012, is designed to facilitate the development of antiepileptogenic therapies by removing barriers and promoting large-scale collaborative research efforts by multidisciplinary teams of basic and clinical neuroscientists with access to extensive patient populations, well-defined and rigidly standardized animal models, and cutting-edge analytic methodology. We focus our proposal on antiepileptogenesis in post- traumatic epilepsy (PTE) following traumatic brain injury (TBI), as this condition offers the best opportunity to determine the time of onset of the epileptogenic process in patients. The EpiBioS4Rx Scientific Premise is: Epileptogenesis after TBI can be prevented with specific treatments; the identification of relevant biomarkers and performance of rigorous preclinical trials will permit the future design and performance of economically feasible full-scale clinical trials of antiepileptogenic therapies. Based on the work from a P20 planning grant, our program will consist of the following: (1) identify biomarkers of epileptogenesis in our animal model and in patients, (2) Develop and utilize a standardized platform for preclinical trials of potential antiepileptogenic (AEG) drugs, (3) Identify 1 or more lead antiepileptogenic drugs for a future interventional clinical trial, (4) Establish a network of advanced TBI centers capable of carrying out future clinical trials featuring our lead antiepileptogenic drugs used in the context of a personalized, medicine-based approach utilizing our panel of biomarkers, and (5) Develop and incorporate a public engagement program involving the mutual education and collaboration of consumers, consumer organizations and professionals to design and execute future large-scale interventional clinical trials of antiepileptogenic therapies.

项目摘要 - EPIBIOS4RX总体抗癫痫疗法的癫痫生物信息学研究（EPIBIOS4RX），一项CWOW建议对RFA-NS-16-012的反应，旨在促进通过消除障碍并促进基本多学科团队的大规模合作研究工作和临床神经科学家，可以使用广泛的患者人群，定义明确且标准化动物模型和尖端的分析方法。我们将建议集中于抗癫痫发生的后发生创伤性脑损伤（TBI）后创伤性癫痫（PTE），因为这种情况为最佳机会提供了确定患者癫痫发作过程的发作时间。 EPIBIOS4RX科学前提是：可以通过特定的特异性预防TBI后的癫痫发生治疗；相关生物标志物的识别和严格的临床前试验的性能将允许未来的设计和经济可行的全尺度临床试验的表现抗癫痫病疗法。根据P20计划赠款的工作，我们的计划将包括如下：（1）在我们的动物模型和患者中识别癫痫发生的生物标志物，（2）发展和利用潜在抗癫痫发作（AEG）药物的临床前试验的标准化平台，（3）识别1个或更多用于将来的介入临床试验的铅抗癫痫药，（4）建立一个晚期TBI网络能够进行未来临床试验的中心，该试验以我们的铅抗癫痫药物为特征利用我们的生物标志物小组的个性化，基于医学的方法的背景，（5）开发和成立了一项公共参与计划，涉及消费者的共同教育和合作，消费者组织和专业人员设计和执行未来的大规模介入临床试验抗癫痫疗法。