Epilepsy treatment research, led by U.S. and U.K. scientists and supported by the NIH’s National Institute of Neurological Disorders and Stroke, has revealed that two unlicensed drugs (levetiracetam and valproate) are just as effective as fosphenytoin/phenytoin, the only currently licensed for epilepsy. The NETT and PECARN Investigator Networks conducted extensive study.

The Study

Involving 384 patients across 57 hospitals in the U.S., patients have been randomly assigned one of the drugs, and thus far, the sponsors have found that about half the patients have seen the seizures halted. This purportedly one of the most extensive studies of its kind.

This clinical trial designed used known as “responsive, adaptive randomization,” which purports to improve upon a study’s efficiency and improve the probability of fingering the best treatment. The study team utilized a software program algorithm to randomize and distribute drug products to patients based on accumulating trial data.

How it Works

Initial treatment of patients includes the sedative benzodiazepine, which works in 7 to 10 patients if given promptly and in the correct dose. For those that don’t respond, phenytoin (or its pro-drug fosphenytoin) is the only licensed drug. The research team sought to gather evidence of the efficacy and safety of fosphenytoin as well as alternative medications levetiracetam and valproate as a second-line treatment. Although both are established for epilepsy, they are not licensed for use in status epilepticus.

Results

As it turns out, the two drugs were equivalent in terms of effectiveness in halting seizures. Moreover, the safety profiles are comparable considering outcomes including life-threatening hypertension, heart problems, seizure recurrence, and death reports Hospital Healthcare. The study results were published in the New England Journal of Medicine

Investigator Comment

Professor Hannah Cock, study co-author from St. George’s University of London and St. George’s University Hospitals NHS Foundation Trust, reported: “Our results show that we now have two other options to give patients who need urgent care, and should give doctors the confidence to use these other medicines.”

Research Sites Involved

The following centers involved in this study:

• University of Virginia

• Medical University of South Carolina

• Children’s National Medical Center, Washington, DC

• University of Michigan

• University of Minnesota

• University of California, San Francisco

• Albert Einstein College of Medicine, Montefiore Medical Center

• National Institutes of Health, Bethesda

• St. George’s, University of London

• St. George’s University Hospitals NHS Foundation Trust

• ConfluenceStat, Orlando

• University of Central Florida College of Medicine

Investigator Networks Involved: NETT and PECARN

The NETT and PECARN investigator networks were leveraged for this extensive clinical trial.

The Neurological Emergencies Treatment Trials (NETT) Network is an extensive network dedicated to emergency issues. The NETT is made up of 22 “Hub” institutions nationwide, each having at least three “Spoke” hospitals. An interdisciplinary approach, NETT, includes emergency physicians, neurologists, and neurosurgeons. The NETT is unique from other clinical trials in that it is long-term, not ending when one study is complete, but moving on to the next while running other studies simultaneously.

PECARN stands for the Pediatric Emergency Care Applied Research Network. It is a project of the Health Resources and Services Administration/Maternal and Child Health Bureau’s (HRSA/MCHB) Emergency Medical Services for Children (EMSC) Program. The network’s goal is the conduct of high priority, multi-institutional research into the prevention and management of acute illness and injuries in children and youth of all ages. PECARN is the first and only federally-funded pediatric emergency medicine research network.

Lead Research/Investigator

Professor Hannah Cock, Study Co-author from St. George’s University of London and St. George’s University Hospitals NHS Foundation Trust

Jaideep Kapur, MB BS, Ph.D., Professor, University of Virginia, Co-Lead of study

Call to ActionThe research team next will assess treatment options for refractory status epilepticus patients—those showing no response to the initial benzodiazepine treatment or follow up drugs. TrialSite News monitors this research group and reports on any material updates.

Source: Hospital Healthcare Europe

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