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‘Exception from informed consent’ study will assess emergency treatment for prolonged seizures

Researchers hope to fill gaps in knowledge about medication-resistant seizures

Three drugs commonly used by emergency room clinicians to treat patients with severe seizures are equally safe and effective, according to results of a nationwide clinical trial published Nov. 27, 2019 in The New England Journal of Medicine. The results showed that three drugs – levetiracetam, fosphenytoin and valproate – stopped seizures and improved responsiveness in approximately half of the study participants.  Specifically, these benefits were seen in 47% of subjects in the levetiracetam group, in 45% of participants in the fosphenytoin group and in 46% of subjects in the valproate group. These differences were not statistically significant. The study included 384 children and adults in emergency rooms at 57 sites around the country, including Oregon Health & Science University.

Oregon Health & Science University is one of 40 centers across the country participating in an emergency medicine study that aims to save and improve the lives of adults and children 2 years and older whose life-threatening seizures are resistant to standard treatment.

Emergency treatment of patients experiencing long-lasting, drug-resistant seizures, also called established status epilepticus, varies significantly from hospital to hospital nationwide. Little is known about which treatments are most — and least — effective. To fill that widespread gap in knowledge, the study, Established Status Epilepticus Treatment Trial (ESETT), will evaluate three commonly used medicines given in emergency departments for prolonged seizures: phenoytoin (fPHT), valproic (VPA) and levetiracetam (LVT).

“The current patchwork approach to treating patients experiencing life-threatening persistent seizures does not provide a cohesive standard of care. The results of this study will make clear which treatments can most swiftly and most safely end seizures. This data will enable us to deliver the best possible outcomes for all patients,” said Craig Warden, M.D., M.P.H., lead researcher for Established Status Epilepticus Treatment Trial (ESETT) at OHSU, and professor of pediatric emergency medicine at OHSU School of Medicine and OHSU Doernbecher Children’s Hospital.

Every year in the United States, there are approximately 120,000 to 180,000 episodes of persistent seizures that do not stop on their own. Of those, a third are established status epilepticus seizures. Prolonged seizures have a profound effect on the patient’s brain. They can interfere with their ability to think and remember, and cause irreversible brain damage or death.

Because a person having a seizure is unconscious and unable to give consent to participate in the study, individuals will be enrolled through a mechanism called Exception from Informed Consent (EFIC) that follows special rules to guide emergency research. EFIC applies when a person’s life is at risk, the best treatment is not known, the study might help the person, and it is not possible to get their permission. As part of that process, the Food and Drug Administration requires that that public be informed about the study.

Individuals who do not wish to be enrolled into the ESETT study can wear an “ESETT Declined” or “No Study” bracelet at all times during the study enrollment period (approximately five years beginning October 2015). Anyone who is wearing this bracelet upon arrival at a participating hospital will not be enrolled in the study. Opt-out bracelets can be obtained by email:, or by calling: 503-494-1230.

The primary objective of ESETT is to shed light on the most and least effective treatments of established status epilepticus among patients 2 years and older.

To raise community awareness of the study, OHSU has held a series of community meetings, and contacted medical clinics and organizations that serve people with seizure disorders. The OHSU Institutional Review Board has reviewed the study. A Data Safety Monitoring Board comprising researchers and physicians not involved in the research will regularly review the data to ensure the safety of those involved.

Two emergency research networks are recruiting patients for ESETT: the Neurology Emergency Treatment Trials (NETT) network and the Pediatric Emergency Care and Applied Research Network (PECARN).

The study is funded through the National Institute of Neurological Disorders and Stroke (grant number: 1U01NS088034-01), a branch of the National Institutes of Health.


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