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Your journey
1What's a trial
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More info
You can access this
clinical trial
if you have
Epilepsy or Post-traumatic Epilepsy
and you are
over 6
years old
This is a second phase trial assessing
efficacy and side effects of the new treatment.
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The purpose

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.

Provided treatments

  • Drug: Levetiracetam

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01463033. The sponsor of the trial is Pavel Klein and it is looking for 126 volunteers for the current phase.
Official trial title:
Pilot: Levetiracetam to Prevent Post-Traumatic Epilepsy