CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 126 enrolled
Drug / intervention
Levetiracetamdrug
Likely dose
Levetiracetam 55 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01463033
NCT01463033Phase 2Completed

Pilot: Levetiracetam to Prevent Post-Traumatic Epilepsy

Pavel Klein·interventional·Posted Nov 1, 2011·Updated Jan 13, 2016

In Brief

A Phase 2 clinical trial evaluating Levetiracetam for Epilepsy and Post-traumatic Epilepsy. Completed, enrolled 126 participants across 2 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 1, 2011
Enrollment StartApr 1, 2005
Primary CompletionJun 1, 2008
Study CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 14.7 years ago

Interventions

Levetiracetamdrug

55 mg/kg/day given in 2 divided doses 12 hours apart