What is Status Epilepticus (SE)?
Status Epilepticus (SE) is a life-threatening condition in which the brain is in a state of persistent seizure. SE is defined as a seizure or recurrent seizures lasting longer than five minutes without stopping or regaining consciousness (waking up).
- Status Epilepticus is life-threatening.
- There are approximately 120,000 – 180,000 episodes of SE each year in the US.
- About one third of SE patients continue to have a seizure despite receiving adequate doses of medicine (benzodiazepines) to make it stop.
- SE affects individuals of all ages, from the very young to the elderly.
What are the long term effects of SE?
Affect one’s ability to think and remember things
Prevent a person from being able to return to work, function normally or independently
Cause permanent brain damage
What is currently done to treat SE?
When a patient having seizures does not respond to a drug like valium doctors may give one of the study drugs to try to stop the seizure. They may also completely sedate the patient with drugs such as propofol or phenobarbitol. This sedation may cause the patient to stop breathing so the doctor will place a breathing tube in the patient’s throat and use a machine to breathe for the patient. In some cases, the doctor may have to use two or more different drugs to stop the seizures.
What is ESETT?
ESETT is an emergency medicine study designed to try to save and improve the lives of people who experience a seizure that will not stop on its own or has not responded to a medicine like valium. Emergency department care of these patients in the US is not the same everywhere.
Because it is not known which drug best treats this type of seizure, different doctors use different medicines. This study plans to look at three commonly used medicines given in the emergency departments for a seizure not stopping: fosphenytoin (fPHT), valproic acid (VPA), and levetiracetam (LVT) to learn which treatment is best at stopping a seizure quickly.
Why is ESETT important?
The best possible outcomes for seizing patients are likely to depend on a treatment that leads to a rapid stop of the seizure. This study will help researchers figure out which drug works best.
What is the purpose of this study?
The reason for doing this study is to find out which of three commonly used drugs is safer and faster at stopping seizures.
Who will be included in the study?
- Any patient who is ≥ 2 years or older with an
- Active recurrent or ongoing seizure lasting longer than five minutes, and
- Has already received an adequate dose of benzodiazepine (like valium) in the past 5-30 minutes for a generalized tonic-clonic seizure could be enrolled.
How will someone be entered into the study?
Every patient coming to the ED who is eligible for the study will get study treatment.
How is ESETT different from other studies?
Normally, researchers get permission before a person can be included in a study. A person having a seizure will not be able to give consent. Since a seizure that will not stop on its own must be treated quickly, there will not be enough time to locate and talk to the person’s legal representative about the study. All patients will be enrolled in the study without his/her legal representative’s consent. This is called “Exception from Informed Consent” (EFIC). Once the representative is located or the participant wakes up, they will be told about the study and asked to give their permission to continue in the study.
What is Exception from Informed Consent (EFIC)?
The U.S. Food and Drug Administration (FDA) is an agency of the federal government that oversees human research involving medicine. The FDA has allowed a set of special rules, called “Exception from Informed Consent” (EFIC), to guide emergency research. EFIC allows research studies to be done in certain emergency situations.
EFIC applies only when:
- The person’s life is at risk, and
- The best treatment is not known, and
- The study might help the person, and
- It is not possible to get permission:
- from the person because of his or her medical problem or
- from the person’s legally authorized representative because the medical problem must be treated very quickly..
Before researchers may do a study using EFIC, they must provide information about the study to the community and get their feedback. This is known as public disclosure and community consultation.
What are the benefits of this study?
Because we do not know which of the study drugs is better, participants may benefit from receiving a better medicine, but this is not guaranteed. Some participants may not get any benefit from being in this research study. However, the information obtained from this study may help seizure patients in the future.
What are possible risks of the study drugs?
The study medicines, fosphenytoin, levetiracetam and valproic acid, are all anti-convulsants, but they work in different ways, and have different risks. The risks of the study medicines are the same whether they are given in the study or for treatment of seizures outside of this study.
When does the study start?
The study is expected to start enrolling in June of 2015 and will continue until 795 people have been entered across the U.S.