Clinical Research in Seizure Treatment at Maimonides Medical Center
Established Status Epilepticus Treatment Trial (ESETT)
In fall of 2016, our Department of Emergency Medicine will conduct a new research study called the Established Status Epilepticus Treatment Trial (ESETT). This is a multi-center, prospective, double-blinded study funded by the National Institute of Neurological Disorders and Stroke (NINDS).
This study aims to evaluate which medication (fosphenytoin, levetiracetam or valproic acid), all commonly administered in emergency departments to treat seizures (Status Epilepticus), is most effective in stopping a seizure quickly.
Adults and children (ages two and older) who have reoccurring seizures, despite treatment with benzodiazepine medication (such as valium), will be enrolled in this trial.
Most often, researchers get consent from a patient before that patient can be included in a study. This study presents a unique situation because a person having a seizure may not be physically able to give consent at the time they could become enrolled in the study. Since a seizure that will not stop on its own must be treated quickly, there may not be enough time to locate and speak with the seizure patient’s legal representative about the study – therefore the patient will become enrolled in the study without his/her legal representative’s consent. This is called “Exception from Informed Consent” (EFIC) – a special set of rules established by the U.S. Food and Drug Administration (FDA). Once the patient’s legal representative is located, or the patient becomes well enough to communicate, he/she will be asked to give consent for participation in the study.
The purpose of this update is to notify our community about the ESETT, offer an explanation of the study, and provide contact information should you have questions or choose to decline participation in the trial. Please contact Maimonides to decline participation in this study.
Dr. Christian Fromm
Emergency Medicine Attending Physician & Director of Research
email@example.com / 718-283-6076
Established Status Epilepticus Treatment Trial (ESETT) http://www.esett.org/
Frequently Asked Questions
What is Status Epilepticus (SE)?
Status Epilepticus (SE) is a life-threatening condition that affects individuals of all ages, in which the brain is in a state of persistent seizure – the seizure (or recurrent seizures) lasts longer than five minutes, without stopping on its own or the person regaining consciousness. There are approximately 120,000 – 180,000 episodes of SE each year in the United States and approximately one third of SE patients continue to have a seizure, despite receiving adequate doses of benzodiazepines to suppress it.
What are the long term effects of SE? SE can:
- Affect one’s ability to think and remember
- Prevent a person from functioning normally or independently
- Limit awareness
- Cause permanent brain damage
- Cause death
What are the current treatments for SE?
When the patient experiencing a seizure does not respond to a drug like valium, doctors may give one of the study drugs including fosphenytoin (fPHT), levetiracetam (LVT) or valproic acid (VPA) to stop the seizure. A doctor may also completely sedate the patient with drugs such as propofol or phenobarbitol. In some cases, a physician may use two or more different drugs to suppress the seizures.
Do the treatment drugs used in this study pose different/greater risks than treatment drugs used outside of this study?
The study medications (fosphenytoin (fPHT), levetiracetam (LVT), and valproic acid (VPA)) are all anti-convulsant drugs commonly used in emergency situations to treat SE, yet the three drugs work in different ways and their risks differ from one to the other. Whether these drugs are administered as part of the study or outside of the study, the possible risks of these drugs do not change.
What is the Established Status Epilepticus Treatment Trial (ESETT)?
ESETT is an emergency medicine research study designed to save and improve the lives of people who experience a seizure that will not stop on its own, or respond to valium or similar medication.
Physicians often use multiple medications to treat SE because it is not known which drug works best. Researchers at Maimonides will analyze three commonly used seizure medications given in emergency departments – fosphenytoin (fPHT), levetiracetam (LVT) and valproic acid (VPA). This study aims to evaluate which treatment is most effective for stopping a seizure quickly.
Why is this research study important?
The best possible outcomes for seizure patients are likely to depend on a treatment that leads to a rapid stop of the seizure. This study will support researchers in determining which of three commonly used drugs is safest and fastest in stopping seizures.
Who will participate in this research study?
Patients who meet these three criteria:
- You ares age two years and older
- You have active recurrent or ongoing seizures lasting longer than five minutes
- You have already received an adequate dose of benzodiazepines in the past 5-30 minutes for a generalized tonic-clonic seizure
How will someone be entered into this research study?
Every eligible patient who comes into the Emergency Room will receive study treatment. (Anyone who declines participation by contacting Maimonides prior to their ER arrival, will be excluded from the study).
What are the benefits of this study?
Since the most effective study drug is unknown, participants may benefit from receiving a better medicine, but this is not guaranteed. Some participants may not receive any benefit from this study. However, the information obtained from this study may help seizure patients in the future.
How is ESETT different from other research studies?
Most often, researchers get permission from a patient before that patient can be included in a study. Due to the medical circumstance for this study, individuals experiencing a seizure will not be able to provide consent upon arrival to Maimonides. Since patients with SE must be treated quickly, there will not be enough time to discuss the study with the patient’s loved ones or legal guardian.
The patient will be enrolled in the study without his or her legal representative’s consent. This is called Exception from Informed Consent (EFIC). The patient will be asked to give permission to continue in the study when he or she regains consciousness or when his or her legal representative is informed.
What is Exception from Informed Consent (EFIC)?
The U.S. Food and Drug Administration (FDA) oversees human research involving medicine. The FDA has established a set of special rules, called Exception from Informed Consent (EFIC), to guide Emergency Medicine research. These guidelines allow research studies to be conducted in unique emergency situations.
When does EFIC apply?
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 permission from the person because of his or her medical condition, or from the person’s legal representative, because the medical condition must be treated very quickly.
Before researchers may conduct a study using EFIC, he or she must provide information about the study to the community and receive feedback, known as public disclosure and community consultation.