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：
9241302
负责人：
JEROME NONE ENGEL
金额：
$ 451.7万
依托单位：
UNIVERSITY OF SOUTHERN CALIFORNIA
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-01-15 至 2021-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9241302
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 Modality Modeling Multicenter Trials Patients Performance Pharmaceutical Preparations Plasma Post-Traumatic Epilepsy Prevention therapy Process Protocols documentation Randomized Rattus Recruitment Activity Research Research Project Grants Resources Sensitivity and Specificity Severities Standardization TBI Patients Techniques Time Traumatic Brain Injury Work base biobank biomarker panel clinical investigation cost effective design experience fluid percussion injury multidisciplinary nondrug therapy novel patient population personalized medicine pre-clinical preclinical study preclinical trial prevent programs research clinical testing response targeted biomarker tool translational study

项目摘要

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.

针对RFA-NS-16-012的CWOW提案，用于抗癫痫疗法（EPIBIOS4RX）的癫痫生物信息学研究旨在促进抗胃疗法的发展，通过驱动障碍的发展，通过驱动障碍，并促进大型患者的基础研究以及基础研究的范围，并促进基本的研究以及基本的基础研究以及基本的基础研究，并定义明确，标准化的动物模型以及尖端的分析方法。在创伤性脑损伤（TBI）之后，我们将建议重点放在抗癫痫发生后（PTE）中，因为这种情况为确定患者的癫痫发作的发作时提供了最佳机会。 EPIBIOS4RX科学前提是：通过特定治疗可以预防TBI后的癫痫发生；鉴定相关的生物标志物和严格的临床前试验的性能将允许未来的抗癫痫疗法的经济可行的全尺度临床试验的设计和性能。基于P20计划赠款的工作，我们的计划将包括以下内容：（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）开发和利用标准化平台，用于临床前试验的潜在抗癫痫发生（AEG）药物的临床前试验；进行未来的临床试验，以我们的铅抗癫痫药物为特色，用于利用我们的生物标志物小组的个性化，基于医学的方法，（5）开发和纳入公共参与计划，涉及消费者，消费者组织和专业人士的共同教育和协作，以设计和执行未来大规模的班级临时性试验。