Epilepsy prevention is one of the great unmet needs in epilepsy. Approximately 15% of all epilepsy is caused by an acute acquired CNS insult such as traumatic brain injury (TBI), stroke or encephalitis. There is a latent period between the insult and epilepsy onset that presents an opportunity to intervene with preventive treatment that is unique in neurology. Yet no phase 3 epilepsy prevention studies, and only 2 phase 2 studies have been initiated in the last 16years. Current prevailing opinion is that the research community is not ready for clinical preventive epilepsy studies, and that animal models should first be refined and biomarkers of epileptogenesis and of epilepsy discovered before clinical studies are embarked upon. We review data to suggest that there is basis to do epilepsy prevention studies now with the current knowledge and available drugs, and that those studies are feasible with currently available tools. We suggest that a different approach is needed from the past in order to maximize chances of success, minimize the cost, and set up platform for future preventive treatment development. That approach should include close coordination of preclinical and clinical development programs in a combined PTE prevention strategy, consideration of polytherapy, and simultaneous, combined clinical development of preventive treatment and of biomarker discovery. We argue that the currently favored approach of eschewing clinical studies until biomarkers are available will delay the discovery of epilepsy prevention treatment by at least 10 years and significantly increase the cost of such discovery.

译文

癫痫预防是癫痫病中巨大的未满足的需求之一。大约15% 的癫痫是由急性获得性CNS损伤引起的,例如创伤性脑损伤 (TBI),中风或脑炎。在侮辱和癫痫发作之间有一个潜伏期,这为干预神经科独特的预防性治疗提供了机会。然而,在过去的16年中,尚未进行3期癫痫预防研究,并且仅启动了2期研究。目前的普遍观点是,研究界还没有准备好进行临床预防性癫痫研究,应该首先完善动物模型,并在开始临床研究之前发现癫痫发生和癫痫的生物标志物。我们回顾了数据,以表明现在有基础可以利用当前的知识和可用的药物进行癫痫预防研究,并且使用当前可用的工具进行这些研究是可行的。我们建议需要一种与过去不同的方法,以最大程度地提高成功机会,最大程度地降低成本,并为将来的预防性治疗开发建立平台。该方法应包括在联合PTE预防策略中密切协调临床前和临床开发计划,考虑多治疗以及预防性治疗和生物标志物发现的同时,联合临床开发。我们认为,在生物标志物可用之前,目前最受欢迎的避免临床研究的方法将使癫痫预防治疗的发现延迟至少10年,并显着增加这种发现的成本。

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