The Epilepsy Bioinformatics Study for Antiepileptogenic Therapy (EpiBioS4Rx)

抗癫痫治疗癫痫生物信息学研究（EpiBioS4Rx）是CWOW响应RFA-NS-16-012的一项提案，旨在通过消除障碍和促进基础和临床神经科学家组成的多学科团队的大规模合作研究工作，从而促进抗癫痫治疗的发展，这些团队可以获得广泛的患者群体，定义良好且严格标准化的动物模型，以及尖端的分析方法。我们的研究重点是外伤性脑损伤（TBI）后创伤性癫痫（PTE）的抗癫痫发生，因为这种情况提供了确定患者癫痫发生过程发病时间的最佳机会。EpiBioS4Rx的科学前提是：通过特定的治疗可以预防脑外伤后的癫痫发生；相关生物标志物的鉴定和严格的临床前试验将允许未来设计和实施经济上可行的抗癫痫治疗的全面临床试验。基于P20计划拨款的工作，我们的项目将包括以下内容：(1)在我们的动物模型和患者中确定癫痫发生的生物标志物；(2)开发和利用一个标准化的平台，用于潜在抗癫痫（AEG）药物的临床前试验；(3)为未来的介入性临床试验确定一种或多种主要抗癫痫药物；(4)建立一个先进的TBI中心网络，能够开展未来的临床试验，在个性化的背景下使用我们的主要抗癫痫药物；(5)制定并纳入一个公众参与计划，包括消费者、消费者组织和专业人士之间的相互教育和合作，以设计和执行未来大规模的抗癫痫治疗的介入性临床试验。

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.