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 总体抗癫痫治疗的癫痫生物信息学研究 (EpiBioS4Rx)，CWOW 的一项提案对 RFA-NS-16-012 的响应，旨在通过以下方式促进抗癫痫治疗的开发消除和促进多学科团队大规模协作研究工作的基本障碍和临床神经科学家可以接触到广泛的患者群体，定义明确且严格标准化我们的建议重点是抗癫痫发生后的动物模型和尖端分析方法。创伤性脑损伤 (TBI) 后的创伤性癫痫 (PTE)，因为这种情况提供了最好的机会确定患者癫痫发作过程的开始时间。 EpiBioS4Rx 的科学前提是：可以通过特定的方法预防 TBI 后的癫痫发生治疗；相关生物标志物的鉴定和严格的临床前试验的进行将允许未来设计和执行经济上可行的全面临床试验基于 P20 规划拨款的工作，我们的计划将包括：以下：（1）在我们的动物模型和患者中鉴定癫痫发生的生物标志物，（2）开发和利用用于潜在抗癫痫 (AEG) 药物临床前试验的标准化平台，(3) 识别 1 种或多种未来介入临床试验的先导抗癫痫药物，（4）建立先进TBI网络能够开展未来临床试验的中心，以我们的主要抗癫痫药物为特色利用我们的生物标记物组进行个性化、基于医学的方法，以及 (5) 开发和纳入涉及消费者相互教育和协作的公众参与计划，消费者组织和专业人士设计和执行未来的大规模介入临床试验的抗癫痫治疗。