DECEMBER 10, 1996


FORT WORTH, Texas--Stroke is the leading cause of disability among adults, and the University of North Texas Health Science Center at Fort Worth is participating in a trial of a drug designed to minimize damage to brain cells.

The clinical study, being conducted in partnership with the Osteopathic Medical Center of Texas (OMCT), will evaluate the safety and effectiveness of fosphenytoin (Cerebyx®). The drug was developed by the trial's sponsor, Parke-Davis.

Stroke, now called a brain attack, occurs when a blood clot or a burst artery interrupts blood flow to an area of the brain. The brain cells destroyed by the initial injury (the infarct) set off a chain reaction that kills brain cells in a larger surrounding area (the penumbra). As a result, the functions and abilities those cells once controlled are permanently impaired or lost altogether. A brain attack can cause paralysis, speech difficulties, memory and thinking problems, coma and -- in one third of the nation's 550,000 cases per year -- death.

Cerebyx® interfers with sodium transport in injured brain cells and may limit brain cell damage from spreading. However, the drug must be administered within four hours following a stroke. Studies show that most patients wait more than 12 hours after the onset of stroke symptoms before seeking treatment.

OMCT has formed a Stroke Team that can react quickly to brain attack and provide the best treatment available to stroke patients and offer them participation in the clinical drug trial. The Stroke Team includes the co-principal investigators for the study, William McIntosh, D.O., and Ed Kramer, D.O. Both are neurologists who are faculty members in the Department of Internal Medicine at the UNT Health Science Center and have staff appointments at OMCT. Additionally, the Stroke Team includes the clinical project manager, Madelon Petersen, R.N., from the health science center's Office of Clinical Research, and a staff of physicians, nurses and other allied health professionals.

"This is the most exciting and hopeful time ever for stroke care and treatment," said Dr. McIntosh. "The traditional attitudes toward stroke are changing to optimism. I am pleased to be involved in this important research."

In addition to this stroke study, physicians and surgeons at the UNT Health Science Center are participating in some 20 other clinical trials, including investigations into improved treatments for hypertension, chronic pain, ulcers, arthritis, cervical disc disease, and migraine.

Dr. Kramer said that in addition to the way physicians treat stroke, they must also change the way their patients view stroke. "Most people do not understand stroke warning signs and they fail to recognize that immediate medical attention is critical. Stroke must be viewed and treated as a medical emergency," he said.

The most common symptoms of the onset of a brain attack, or stroke, are:
€one-sided numbness, weakness or paralysis of the face, arm or leg
€sudden blurred or decreased vision
€difficulty speaking or understanding even simple statements
€dizziness, loss of balance or loss of coordination, especially when combined with another symptom
€sudden, severe, unexplainable headache.

Dr. McIntosh said symptoms can be misleading because they often do not cause the physical pain that most people associate with a medical emergency.
The clinical trial in Fort Worth, one of 40 sites for this project, is seeking to enroll 20 stroke patients during the course of the study. The key, said Dr. McIntosh, is getting immediate attention in every case of suspected stroke.

Additional information on this study is available from UNT Health Science Center at (817) 735-0255 or OMCT (817) 735-4466.

For further information Contact:
William E. McIntosh, D.O.
Associate Professor, Internal Medicine
(817) 735-2663

Edward Kramer, D.O.
Assistant Professor, Internal Medicine
(817) 735-2663

Madelon Petersen, RN
Office of Clinical Research
(817) 735-2358