Stanford Physician Informs Area Residents About Study to Compare Anti-Seizure Treatments

For Release: September 23, 2008

Media Contact: Liat Kobza
lkobza@stanfordmed.org
(650) 723-1462

Writer: Diane Rogers

STANFORD, Calif.— In the Web site video, a young boy lays on the grass, shaking violently.
His seizure could be the result of epilepsy, injury, drugs, a stroke or tumor, or a number of other neurological factors. But whatever the cause, the faster he is treated, the better.
“You want to stop a seizure as soon as you can,” said James Quinn, MD, associate professor and director of research in emergency medicine at the Stanford University School of Medicine. “Paramedics now stop them with medications in the field, but there’s a big variation in practice about what medications to use.”

He and colleagues throughout the country are about to launch an effort to determine whether one treatment method is better than the other. What’s unusual about the effort is that the patients who participate in the study of the treatments won’t be able to give informed consent at the time, and so Quinn and his team want to give the community the opportunity to learn more about the study now and, if they choose, opt out of possible participation.

Quinn, who also treats patients in the emergency room at Stanford Hospital & Clinics, will be heading up the Stanford portion of the planned national survey to study how best to treat prolonged seizures known as status epilepticus. The three-year study, known as Rapid Anticonvulsant Medication Prior to Arrival Trial or RAMPART, is scheduled to start in early 2009.

This trial is part of the Neurological Emergencies Treatment Trial Network, which consists of 17 academic medical centers, including Stanford. The RAMPART study will determine whether anti-seizure medicine works better and more quickly when it is delivered intravenously through an I.V., or when it is given as a shot in a muscle.

“The I.V. may go faster in the bloodstream to the brain, but it can take time to start an I.V. if someone is having a grand mal seizure,” Quinn said. “And that delay might make the other approach, where the medicine is absorbed quickly into the muscle, actually faster in getting to the brain.”
In the RAMPART clinical trial, patients will be randomly assigned to treatment groups where they would either receive lorazepam (Ativan) intravenously, or be injected with midazolam (Verced) with a new fast-release syringe. Both medications have similar effects in stopping seizures, Quinn said, but there have been no head-to-head comparisons that would help medical professionals know of any differences between the two.

What’s unusual about the planned phase-3 clinical trial is that the patients will be unconscious when they are enrolled by paramedics.

Unlike participants in most other research studies, patients experiencing seizures will not be able to give their permission. Instead, they will be treated under federal rules that provide for what is called an exception from informed consent. This exception is allowed only in studies of life-threatening emergencies.

“It’s really the only way to do emergency medicine research,” Quinn said.

He and co-investigators Christine Wijman, MD, associate professor of neurology and neurological sciences, and of neurosurgery, and Ronald Torres, MD, clinical assistant professor of neurosurgery, are nevertheless eager to explain how the study will work to members of the public who are served by 19 community hospitals, including Stanford Hospital, in Santa Clara and San Mateo counties. Quinn said some 50 patients from the area ultimately might participate in the local portion of the trial, which is planned to involve more than 800 patients nationwide.

“We want to understand people’s concerns about the study,” Quinn said. “And people who don’t want to participate can opt out.” They can do that by wearing red bracelets that will be provided, at no cost, by the researchers. Those who opt out of the study and experience a seizure would receive whatever treatment was the standard protocol—one of the two options in the study—but their outcomes would not be tracked.

Area residents can phone in their questions about the study, or register their opinions, by calling study coordinator Stephanie Casal, RN, at (650) 721-2645. They also can go to the study Web site at https://med.stanford.edu/survey/rampart to watch a video and fill out a quick survey.

“We want to reach as many people as possible, to let them know we’re going to be doing this RAMPART study, giving two different medications by two different routes, and that the study will be unique in that patients will be enrolled without their consent,” Quinn said. “And we want to hear their opinions and feelings about the study.”

The RAMPART study is being funded by the National Institutes of Health.
Stanford University Medical Center integrates research, medical education and patient care at its three institutions — Stanford University School of Medicine, Stanford Hospital & Clinics and Lucile Packard Children’s Hospital at Stanford. For more information, please visit the Web sites of Stanford Hospital & Clinics at www.stanfordhospital.org or the Office of Communication & Public Affairs at the School of Medicine at http://mednews.stanford.edu/.

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