Clinical trialNCT01960075CompletedPhase 3Interventional

Established Status Epilepticus Treatment Trial

SponsorUniversity of VirginiaEnrollment478Benzodiazepine Refractory Status Epilepticus

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Jaideep Kapur, MBBS, PhD
University of Virginia
Study Chair
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James Chamberlain, MD
Children's National Research Institute
Principal Investigator
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Jordan Elm, PhD
Medical University of South Carolina
Principal Investigator
clinicaltrials.gov ↗
Robert Silbergleit, MD
University of Michigan
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

65 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Banner University Medical Center - South Campus
Tucson, Arizona, United States
Banner University Medical Center-Tucson Campus
Tucson, Arizona, United States
Ronald Reagan Ucla Medical Center
Los Angeles, California, United States
Uc Davis Children'S Hospital
Sacramento, California, United States
San Francisco General Hospital
San Francisco, California, United States
Ucsf Benioff Children'S Hospital
San Francisco, California, United States
Ucsf Medical Center
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
Christiana Hospital
Newark, Delaware, United States
A.I.Dupont Hospital for Children
Wilmington, Delaware, United States
Children'S National Medical Center
Washington D.C., District of Columbia, United States
Children'S Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
University of Kentucky Hospital
Lexington, Kentucky, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
C.S. Mott Children'S Hospital
Ann Arbor, Michigan, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Children'S Hospital of Michigan
Detroit, Michigan, United States
Detroit Receiving Hospital
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Sinai-Grace Hospital
Detroit, Michigan, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
University of Minnesota Masonic Children'S Hospital
Minneapolis, Minnesota, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
St. Louis Children'S Hospital
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Kings County Hospital Center
Brooklyn, New York, United States
Maimonides Medical Center
Brooklyn, New York, United States
Suny Downstate Medical Center
Brooklyn, New York, United States
Nyp Columbia University Medical Center
New York, New York, United States
Nyp Morgan Stanley Children'S Hospital
New York, New York, United States
Cincinnati Children'S Hospital Medical Center
Cincinnati, Ohio, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Nationwide Children'S Hospital
Columbus, Ohio, United States
Osu Wexner Medical Center
Columbus, Ohio, United States
Oregon Health & Science University Hospital
Portland, Oregon, United States
Crozer-Chester Medical Center
Chester, Pennsylvania, United States

25 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

FosphenytoinLevetiracetam →Valproate →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Oct 2015
Primary completion: 28 Feb 2019
Completion: 31 May 2019
Last update posted: 14 Jun 2021
Registered enrollment: 478
Registry id: NCT01960075

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.