Preventing Epilepsy After Traumatic Brain Injury
Abstract
The purpose of this study was to determine the feasibility of performing a single center epilepsy prevention trial after traumatic brain injury (TBI), to determine safety and tolerability of topiramate in the treatment of early seizures following TBI, and to compare the efficacy of topiramate to prevent early seizures to the standard of care (phenytoin). A secondary objective was to obtain data necessary to design of a randomized clinical trial for preventing epilepsy and improving neurological outcome after TBI. Initially, we formulated the protocol and documents required by regulatory bodies and received approval by the IRB at the University of Pennsylvania, HRRPO at the US Army, and the FDA. The infrastructure for the study was established, including interactions with the trauma center, neurosurgical services, EEG laboratory, pharmacy, etc. Subject recruitment began but was initially very slow and the protocol was revised to eliminate several major obstacles. Ultimately, we enrolled many fewer subjects into the study then intended and the reasons for that were carefully analyzed, as were other lessons learned from the pilot trial. We have also organized a NINDS workshop on Biomarkers for Epileptogenesis and a program to assist gulf war veterans with TBI, and have been influential in enhancing epilepsy care for veterans within the DVA.
Document Details
- Document Type
- Technical Report
- Publication Date
- Feb 01, 2009
- Accession Number
- ADA506626
Entities
People
- Marc A. Dichter
Organizations
- University of Pennsylvania