Preventing Epilepsy After Traumatic Brain Injury; Annual rept. 1 Feb 2007-31 Jan 2008

摘要

The purpose of this study is to determine the safety and tolerability of topiramate (TPM) in the treatment of early seizures following traumatic brain injury (TBI) and to compare the efficacy of TPM to prevent early seizures to the standard of care (phenytoin). A secondary objective is to obtain the data necessary to design a randomized clinical trial to determine if TPM can prevent epilepsy and improve neurological outcome after TBI. In the first two years of the study we formulated the protocol and all documents required by regulatory bodies. These were approved by the IRB at the University of Pennsylvania HRPO at the US Army and the FDA. The infrastructure for the study was established relevant personnel were hired and the patient recruitment methods interactions with the trauma center neurosurgical services EEG laboratory pharmacy etc. were organized. Subject recruitment began. Initial subject recruitment was very slow and the protocol was revised to eliminate several major obstacles. We have enrolled 5 subjects into the study; two in the phenytoin arm one in the short term topiramate one in the 3 month topiramate arm; one subject was withdrawn after testing positive for illicit drug use. We have also organized a NINDS-sponsored workshop on Biomarkers for Epileptogenesis and a program to assist TBI veterans.