Safety and effectiveness of drugs to be determined in patients with life-threatening seizures taken to University Hospital’s Emergency Department
Researchers at The University of Texas Health Science Center at San Antonio and University Health System will soon begin a study to test three commonly used medications for patients who remain in status epilepticus, or SE, despite initial treatment.
Status epilepticus is an epileptic seizure lasting more than five minutes, or multiple seizures within a five-minute period without the patient returning to consciousness.
The Established Status Epilepticus Treatment Trial, or ESETT, is a five-year, multi-center trial sponsored by the National Institutes of Health.
Patients arriving at University Hospital with prolonged seizure activity will first be given a dose of benzodiazepines according to standard-of-care guidelines. If the seizure activity does not stop, they will be enrolled in the trial and randomly assigned to receive one of three study medications — all of which are currently used to treat seizures.
The study’s goal is to determine which of the three is most effective at stopping prolonged seizures: fosphenytoin (Cerebyx), levetiracetam (Keppra) or valproic acid (Depakote). All three are approved by the Food and Drug Administration for the treatment of seizures.
Because seizures can be life-threatening if not stopped immediately, there may not be time to talk to a legal guardian or a patient’s representative about the study before the medication is given. For that reason, patients enrolled in ESETT fall under a special set of government rules called “exception from informed consent.” These rules allow research studies to be done in emergency situations without asking for the patient’s consent.
The patient or legally authorized representative will be notified about their enrollment as soon as possible and consent will be obtained for ongoing participation.
OPTING OUT: For those who do not wish to be enrolled in this study, there are two ways to opt out:
- Medic Alert membership — If you have an existing medic alert tag or bracelet, you can add “ESETT Study Declined” to your profile
- Opt out bracelets — You can wear an “ESETT Declined” bracelet for the duration of the study (approximately five years). The bracelets may be requested free of charge by contacting the study coordinator, Lorraine Dishman at (210) 567-8223 or email at Dishman@uthscsa.edu