Preventing Epilepsy after Traumatic Brain Injury
Annual rept. 1 Feb 2006-31 Jan 2007
PENNSYLVANIA UNIV PHILADELPHIA
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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 HSRRB at the USArmy 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 in order to conduct the research. Patient recruitment was begun but after screening more than 100 prospective patients with TBl no patients were able to be admitted to the study as it was constituted for several unforeseen technical reasons. The protocol has been revised to eliminate these obstacles. In addition a NINDS-sponsored workshop on Biomarkers for Epileptogenesis was held and a program of new potential biomarkers was incorporated into the study.
- Medicine and Medical Research