Results of phase 2 safety and feasibility study of treatment with levetiracetam for prevention of posttraumatic epilepsy.

ABSTRACT:

Objectives

To evaluate the safety and tolerability of treatment with levetiracetam and determine the trough levels of levetiracetam in patients with traumatic brain injury (TBI) who are at high risk for posttraumatic epilepsy (PTE).

Design

Open-label, nonrandomized phase 2 study with 2 arms comparing levetiracetam treatment vs observation.

Setting

Two level 1 trauma centers.

Patients

A total of 422 participants 6 years or older with TBI who have a 20% risk for PTE were screened. Of these participants, 205 (48.6%) were eligible. A total of 126 participants were enrolled: 86 adults and 40 children. A total of 66 participants were in the treatment group (46 adults and 20 children), and a total of 60 participants were in the observation group (40 adults and 20 chil

SUBMITTER: Klein P 

PROVIDER: S-EPMC4798941 | biostudies-literature | 2012 Oct

REPOSITORIES: biostudies-literature