Preventing Epilepsy After Traumatic Brain Injury
Abstract
The purpose of this study is to determine the safety and tolerability of topiramate in the treatment of early seizures following traumatic brain injury (TBI), and to compare the efficacy of topiramate to prevent of early seizures to the standard of care (phenytoin). A secondary objective is to obtain data necessary to design of a randomized clinical trial to determine if topiramate can prevent epilepsy and improve neurological outcome after TBI. In the first year of the study, we formulated the protocol, informed consent, and other documents required by regulatory bodies. All of these were submitted to the IRB at the University of Pennsylvania, HSRRB at the US Army, and the FDA. The approval process for this protocol, especially from the HSRRB, including revisions, took approximately one year. During this time we established the infrastructure for the study, hired relevant personnel and organized the patient recruitment methods, interactions with the trauma center, neurosurgical services, EEG laboratory, pharmacy, etc. in order to conduct the research. Patient recruitment is now commencing.
Document Details
- Document Type
- Technical Report
- Publication Date
- Feb 01, 2006
- Accession Number
- ADA452227
Entities
People
- Marc A. Dichter
Organizations
- University of Pennsylvania