Established Status Epilepticus Treatment Trial

Completed · Phase 3

Conditions studied: Benzodiazepine Refractory Status Epilepticus

In brief

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.

Key facts

Study ID

NCT01960075

Run by

University of Virginia

People needed

478

Starts

2015-10-01

Expected to finish

2019-05-01

Last updated by the study team

2021-06-14

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• 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 Medical Center — San Francisco, California, United States
• UCSF Benioff Children's Hospital — 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
• Grady Memorial Hospital — Atlanta, Georgia, United States
• Children's Healthcare of Atlanta at Egleston — 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 Medical Center — Minneapolis, Minnesota, United States
• Banner University Medical Center - South Campus — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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