VCU Medical Center soon could join more than 50 hospitals across the country in a research trial exploring the best drug to treat ongoing and life-threatening seizures.
If the center’s able to enroll in the trial, it would land funding from the National Institutes of Health starting at $250,000, which is expected to fully cover costs.
But before the study can begin, researchers must get over an ethics hurdle. Because a continuous seizure often renders a patient unconscious, study participants wouldn’t be able to give consent before receiving the treatment.
Researchers estimate that 120,000 to 180,000 cases occur annually in the United States. Seizures occur when the vehicles upon which information travels through the brain — synapses and neurons — fire at once uncontrollably, hogging the road on the information highway. For many people these neurological episodes stop, but for sufferers of status epilepticus they are prolonged and cease only with the help of drugs.
Sometimes a physician’s first drug of choice, a muscle relaxer such as valium — which helps get the connections between brain cells back on track — doesn’t work. A second line of defense is one of three drugs — fosphenytoin, levetiracetam or valproic acid. But it’s unclear which is most effective.
That’s what participating researchers in neurology and emergency medicine are trying to determine with the $21.4 million study, being led nationally by Dr. Jaideep Kapur at the University of Virginia.
Nearly 800 cases are needed nationally to complete a detailed study, which could take as long as four years. Virginia Commonwealth University expects to have only four subjects a year, says Dr. V. Ramana Feeser: “So this is a lot of effort for a very small number.”
But it’s worth it, she says: “If we didn’t have the entire nation committed to doing this research, we wouldn’t have the number of patients needed to find good answers to these questions.”
Anyone admitted to the emergency department for the condition is eligible. A Food and Drug Administration law allows exemptions from informed consent when permission is impossible to obtain, the person’s life is at risk, the best treatment isn’t known and the study might help the person.
Once the patient is conscious, he or she can decide to continue with the trial and will be monitored until discharge from the hospital.
Those who wish to be exempt may wear a bracelet that declines the trial. The trial extends to children as young as 2, and parents may give consent.
The university says that research will be stopped midway if one drug shows marked effectiveness or there are side effects.
Because of the unique nature of the study, the FDA requires researchers to hold community meetings to hear from residents and local organizations. Feeser spoke during City Council’s Education Health and Human Resources Committee last month.
The city isn’t required to give an OK for the trial. That’s left to one of VCU’s four institutional review panels, made up of physicians and community members. Feeser says she doesn’t expect a decision before January.
A National Institutes of Health website says that only two hospitals have started recruiting patents — Grady Memorial Hospital in Atlanta and Stanford University Medical Center in California.