The Epilepsy Bioinformatics Study for Antiepileptogenic Therapy (EpiBioS4Rx)

抗癫痫治疗的癫痫生物信息学研究 (EpiBioS4Rx)

• 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
• 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

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.

用于抗癫痫治疗的癫痫生物信息学研究(EpiBioS4Rx)是CWW针对RFA-NS-16-012提出的一项建议，旨在通过消除障碍并促进基础和临床神经科学家多学科团队的大规模协作研究工作来促进抗癫痫治疗的开发，这些团队可以接触到广泛的患者群体、定义明确和严格标准化的动物模型和尖端分析方法。我们将重点放在创伤性脑损伤(TBI)后创伤性癫痫(PTE)的抗癫痫治疗上，因为这种情况提供了确定患者癫痫发病过程的最佳时机。EpiBioS4Rx的科学前提是：脑外伤后癫痫的发生可以通过特定的治疗方法来预防；相关生物标记物的识别和严格的临床前试验的执行将使未来能够设计和执行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，我们的计划将包括以下内容：(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)开发和利用潜在抗癫痫(AEG)药物的临床前试验的标准化平台，(3)为未来的干预性临床试验确定1种或更多先导抗癫痫药物，(4)建立先进的脑损伤中心网络，能够开展未来的临床试验，利用我们的生物标志物小组，在个性化、基于药物的方法中使用我们的主要抗癫痫药物，以及(5)制定并纳入一项公众参与计划，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抗癫痫治疗的介入临床试验。