Phase III of Stroke Trial Completed

Enrollment in the world's largest clinical trial for the stroke drug citicoline has been completed. Researchers at the School of Medicine are participating in this 900-patient trial to study how citicoline treatment given within 24 hours following a stroke may limit neurological damage.

"Ischemic" stroke is caused by a blockage of blood flow to the brain. The double-blind, placebo-controlled trial includes patients with moderate to severe ischemic stroke enrolled at more than 170 participating hospitals in the United States and Canada. Patients are treated with citicoline tablets, 2,000 milligrams daily, or with matching placebo tablets for six weeks following the stroke. Researchers will study the change in neurological function of patients between the time of enrollment and the end of the follow-up period (12 weeks), as measured by the National Institutes of Health Stroke Scale scores.

"We were thrilled to be able to offer acute stroke patients more options for treatment by doing this study," said Christina M. Burch, M.D., assistant professor of neurology at the Souers Stroke Institute. "The usual window of opportunity for treatment of acute ischemic stroke is three hours, but this study offered more options for available therapies over a 24-hour period. We're looking forward to the results of this important clinical trial to determine if drugs that protect the brain after stroke are effective."

Citicoline is believed to work a number of different ways to limit stroke-induced brain damage:

It limits the extent of damage caused by interrupted blood flow, by preventing the accumulation of fatty acids.
It promotes recovery of brain function by providing two components, cytidine and choline, required to form nerve cell membranes.
It promotes production of acetylcholine, a neurotransmitter associated with mental function.

This study is the largest clinical trial of citicoline in stroke conducted to date in the world. Preliminary results from the trial after data analysis are expected to be available near the end of 1999 or the beginning of the year 2000.

According to a recent report by the American Heart Association, stroke is the third leading cause of death in the United States. Approximately 700,000 people suffer a new or recurrent stroke each year, and 160,000 deaths occur annually as a result of stroke in the United States. Ischemic stroke comprises more than 80 percent of all strokes and is associated with high levels of death and disability.

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