The primary objective is to determine the most effective and/or the least effective treatment
of benzodiazepine-refractory status epilepticus (SE) among patients older than 2 years. There
are three active treatment arms being compared: fosphenytoin (FOS),levetiracetam (LEV), and
valproic acid (VPA).
The second objective is comparison of three drugs with respect to secondary outcomes.
The final objective is to ensure that the trial is informative for treatment of established
SE in children by describing the effectiveness, safety, and rate of adverse reactions of
these drugs in children.
Phase:
Phase 3
Details
Lead Sponsor:
University of Virginia
Collaborators:
Children's National Research Institute Children's Research Institute Medical University of South Carolina National Institute of Neurological Disorders and Stroke (NINDS) University of Michigan University of Minnesota University of Minnesota - Clinical and Translational Science Institute