Researchers at the Medical Center of Hackensack University conducted a study of three drugs now proven to be safe and effective for the treatment of severe seizures.
The common definition of epilepsy is that it disrupts the electrical system in the brain resulting in seizures.
SE is characterized as a condition whereby the brain is in a constant state of seizure. SE seizures are life-threatening.
The seizures generally last over five minutes and occur repeatedly. The episodes of SE in the U.S. range from 120,000 to approximately 180,000 every year.
The Established Status Epilepticus Treatment Trial (ESETT)
The three medications that were examined in ESETT are used regularly in emergency departments for the treatment of SE.
The drugs levetiracetam, fosphenytoin, and valproate were studied with a goal of determining which provided the most efficacy and safety.
One of the most important results of the trial was that no clinically evident seizures were reported with treatment. There was also a sixty-minute improvement in the consciousness level after the infusion. No other anticonvulsant medication was administered.
A Nationwide Study
Three hundred eighty-four individuals were enrolled in the study.
The SE study was conducted in fifty-eight hospitals throughout the U.S., including Hackensack University’s Epilepsy Center. All participating hospitals specialized in emergency neurological research.
Hackensack University’s Epilepsy Center is accredited as Level IV which is the highest level that can be attained for a center.
The study was granted an Exception From Informed Consent (EFIC) through a special regulation of the FDA. The EFIC designation automatically gives research studies permission to proceed in specific emergency situations even though they had not yet received consent.
Dr. Joseph Underwood, Chairman of Emergency Medicine at Meridian Health, commented that the study was extremely challenging. He explained that it included many levels of regulation.
He specifically mentioned a specialized regulation (EFIC). The research team complied with this regulation by reaching out to the local community and distributing disclosure material. They also held public meetings and other EFIC disclosure events.
Dr. Underwood credits the unique design of the trial for the research team to be able to analyze the three drugs in a timely manner.