The Established Status Epilepticus Treatment Trial (ESETT) Established Status Epilepticus Treatment Trial (ESETT)
What is the purpose of the ESETT Study?
ESETT is a research study looking at medicines to treat long seizures. The study will begin at Froedtert Hospital and Children’s Hospital of Wisconsin in January 2016. Researchers will compare three medicines used to treat long seizures to decide which medicine is best at stopping a long seizure. The goal of this research is to improve the lives of people who have long seizures.
How is the ESETT study being conducted in Milwaukee?|
Emergency department care of patients with a long seizure in the United States is not the same everywhere. Doctors typically use their best medical judgment about which medicines to use after benzodiazepines do not work. However, which of the medicines will work best is not known. This study will compare three commonly used medicines given in emergency departments for long seizures. These three common medicines are fosphenytoin, valproic acid, and levetiracetam. Researchers will learn which treatment is best at stopping a long seizure quickly. All of these medicines are already being used for seizures in children and adults. Each person will receive one dose of one of the study medicines. Which medicine a person receives is decided by chance. Patients will receive all other standard treatments for seizure. If you are not enrolled in the study, you will get the standard medical treatment given to people who are having a long seizure at Froedtert Hospital or Children’s Hospital of Wisconsin. This study meets the U.S. Food and Drug Administration guidelines for exception from informed consent under emergency circumstances. View more information about Exception From Informed Consent research.
Opting Out of the Study
We respect that a person may not want to be enrolled in the Exception from Informed Consent research study called Established Status Epileptics Treatment Trial (ESETT) being done at Froedtert Hospital and Children’s Hospital of Wisconsin. If you do not want to be a part of this study and want to “opt-out”, you can ask to be sent a free opt-out bracelet or necklace.
Research team members are trained to NOT enroll patients wearing an opt-out bracelet or necklace in ESETT. In order for children 17 years and younger to opt-out, please call or email the ESETT study team to talk about the options. If you are not enrolled in the study, you will get the standard medical treatment given to people who are having a long seizure at Froedtert Hospital or Children’s Hospital of Wisconsin.
To get an opt-out bracelet or necklace, you can either call the ESETT Study Team at (414) 805-6493 or email us at ESETT@mcw.edu. Your bracelet or necklace will be immediately sent to the address you provided.
MedicAlert will no longer be offered as a method of opting-out of the ESETT study.
ESETT Intermediate Public Announcement (PDF)
ESETT Risk Benefit Announcement (PDF)
ESETT End of Study Public Announcement (PDF)