UA helps test epilepsy drug

By Keith Allen

Arizona Daily Wildcat

The UA's Department of Neurology is participating in a nationwide clinical trial of a new treatment to fight the symptoms of epilepsy.

The treatment involves a pocketwatch-sized device, said David Labiner, M.D., director of the Arizona Comprehensive Epilepsy Program.

The clinical trial is studying 230 patients with epilepsy at 20 sites nationwide, said Shawn Lunney, director of marketing for the Houston-based Cyberonics Inc.

This is not a cure for epilepsy, Labiner said, though patients may think so because their seizures may stop.

Epilepsy, according to Webster's Ninth New Collegiate Dictionary, is "any of various disorders marked by disturbed electrical rhythms of the central nervous system, and typically manifested by convulsive attacks."

Two million people nationwide have epilepsy, Lunney said. Of those, 75 to 80 percent receive needed treatment while the other 20 to 25 percent continue to have seizures, he said.

"We are treating the symptoms (of epilepsy), not changing the underlying brain pathology," he said. Labiner said that this is a "potentially promising" treatment.

Labiner said the device disrupts rhythmic activity in the vagus nerve, one of the cranial nerves, by stimulating it. This rhythmic activity is otherwise known as a seizure, he said.

Lunney said that neurophysician Jacob Zabarra at Temple University conceived the idea for the device, called the NeuroCybernetic Prothesis System. The first implant on a human was done in November 1988, and the device has been approved for use in 24 countries, though it is still in clinical trials in the United States.

Cyberonics Inc. was founded on the device's development in 1987, Lunney said.

Lunney said that people in his company recommended Labiner and the UA Neurology Department because Labiner had trained with Cyberonics Inc.

The device will be useful for epilepsy patients that cannot tolerate medicines for epilepsy or who want to avoid brain surgery, Labiner said.

"It is just another vehicle for treating seizures," Labiner said.

The UA is studying patients from New Mexico, Phoenix and Southern Arizona, he said.

Cyberonics Inc. is spending about $5 million on the study of this device, Lunney said. This includes any medical treatment, travel for patients or other costs incurred during the study, he said.

Lunney said that all the patients for the study have been enrolled and that the study will begin next month.

Patients must have at least four seizures a month, must not be pregnant and must be between the ages of 12 and 65 for the study to be effective, Labiner said.

The study is taking place over a two-phase, seven-month period: a "base" phase where the patient is given preliminary tests and taken through the pre-treatment planning, and the "study" phase where the device is implanted and tested, Labiner said.

Lunney said he expected one-third of the patients to improve profoundly, another third to experience a significant reduction in seizures and the last third to have less than 50 percent improvement.

"We don't know why it works," Labiner said. "And we don't know why it may act differently from one person to another."

Labiner said side effects of the treatment involve gastrointestinal problems, cramping, diarrhea and hoarseness because of the device's placement near the throat. He said no serious side effects have been discovered.

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