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Established Status Epilepticus Treatment Trial

NCT01960075 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 478

Last updated 2021-06-14

Study results available
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Summary

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.

Conditions

  • Benzodiazepine Refractory Status Epilepticus

Interventions

DRUG

Fosphenytoin

DRUG

Levetiracetam

DRUG

Valproic acid

Sponsors & Collaborators

  • University of Michigan

    collaborator OTHER

  • Medical University of South Carolina

    collaborator OTHER

  • Children's National Research Institute

    collaborator OTHER

  • University of Minnesota

    collaborator OTHER

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • University of Virginia

    lead OTHER

Principal Investigators

  • Jaideep Kapur, MBBS, PhD · University of Virginia

  • Robert Silbergleit, MD · University of Michigan

  • James Chamberlain, MD · Children's National Research Institute

  • Jordan Elm, PhD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2019-02-28
Completion
2019-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01960075 on ClinicalTrials.gov