Research Trial for Emergency Room Seizure Medicines
The emergency departments of Rhode Island Hospital and its pediatric division, Hasbro Children’s Hospital, are participating in a research study to compare three seizure medications administered during emergencies. The seizure study, known as Established Status Epilepticus Treatment Trial (ESETT), is sponsored by the National Institutes of Health.
Fosphenytoin, levetiracetam, and valproic acid are used to treat seizures in the U.S. emergency departments. However, it is not known which drug is the best drug to stop persistent seizures, a condition called status epilepticus. A clinical trial to study these drugs will be initiated at Rhode Island and Hasbro Children’s hospitals. Persons affected by seizures can decline enrollment in the ESETT study by contacting the study leadership and requesting an “opt out” medical bracelet.
Eligible patients who present to the emergency department with a seizure that does not respond to standard first line therapy (a drug called a benzodiazepine) will be enrolled in the ESETT study. One of the three study medicines will be provided. The ESETT study will assess which seizure medication is the best at stopping the seizure. As soon as possible after enrollment, the hospitals will attempt to obtain consent from the patients or their legal representatives for continued participation in the study. Patients may withdraw from the study at any time.
Hospitals are required to inform the community when the U.S. Food and Drug Administration (FDA) authorizes a study to be conducted under exception from informed consent. This study meets all four criteria for such exception because: 1) the patient’s life at risk; 2) the treatments currently used are unproven; 3) the best treatment is not known; and 4) it is not possible to get permission from the patient because of his or her medical condition or from the person’s legally authorized representative because the medical problem must be treated very quickly.
Persons afflicted with seizures and their families, as well as other interested members of the community are invited to contact Rhode Island and Hasbro Children’s hospitals to learn more about the study or to opt out by calling 401-444-3813. ESETT is expected to begin at Rhode Island and Hasbro Children’s hospitals in November.