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Pilot: Levetiracetam to Prevent Post-Traumatic Epilepsy
Head injury is the cause of approximately 5% of all epilepsy in the US. Past attempts at preventing epilepsy by treatment with older antiepileptic drugs have been unsuccessful. Levetiracetam is a novel AED with potent antiepileptogenic properties in animal models of epilepsy. It has a favorable side effect and pharmacokinetic profile. It is therefore a strong candidate for a clinical trial of epilepsy prevention following traumatic brain injury (TBI). However, there has been no experience in administering levetiracetam rapidly to individuals with acute TBI. The investigators propose to initiate the evaluation of levetiracetam in prevention of post-traumatic epilepsy by determining the safety, tolerability, pharmacokinetics and feasibility of acute and chronic administration of levetiracetam to individuals with head injury with a high risk for developing post-traumatic epilepsy. Further, the investigators will follow subjects for 2 years after injury in order to obtain pilot data about effect of levetiracetam on PTE. This pilot study is the first step in evaluation of levetiracetam in prevention of post-traumatic epilepsy.
Age
6 - No limit years
Sex
ALL
Healthy Volunteers
No
Children's National Medical Center
Washington D.C., District of Columbia, United States
MedStar Research Institute
Washington D.C., District of Columbia, United States
Start Date
April 1, 2005
Primary Completion Date
June 1, 2008
Completion Date
February 1, 2010
Last Updated
January 13, 2016
126
ACTUAL participants
Levetiracetam
DRUG
Lead Sponsor
Pavel Klein
Collaborators
NCT06700356
NCT02531880
NCT05871372
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