Results of citicoline trial to be presented this week at annual American Heart Association Stroke Conference
A stroke-fighting drug up for possible approval by the U.S. Food and Drug Administration showed mixed results in a nationwide clinical trial, according to research being presented this Saturday, February 7, at the annual American Heart Association Stroke and Circulation Conference in Orlando, Florida. Wayne Clark, M.D., associate professor of neurology, and director of the Oregon Stroke Center at Oregon Health Sciences University, was lead researcher in a multicenter clinical trial of citicoline. Citicoline, manufactured under the brand name Ceraxon (TM) by Massachussetts-based Interneuron Pharmaceuticals Inc. has shown promise of reducing stroke-related injury by stablizing cell membranes long enough to prevent large-scale brain cell damage after stroke.
The clinical trial, involving nearly 400 patients in 33 centers nationwide, showed no statistically significant difference in five areas--including full recovery and mortality rates, neurological and cognitive function--between patients with stroke who were given citicoline, and those who were given a placebo. "However, the drug did appear to produce an improvement over placebo in a subset of patients with moderate to severe strokes," said Clark. Patients were first given the drug or a placebo within a few hours of their stroke, then for six weeks afterward, with a six-week, post-treatment follow-up period. Interneuron submitted a New Drug Application for citicoline to the FDA in December. The drug is already being marketed in approximately 30 countries.
Clark is scheduled to present the results of the clinical trial on Saturday, February 7, 1998 at the Omni Rosen Hotel in Orlando, Florida. Call Henry Sessions at (503) 494-8231 if you wish to speak with Clark before the presentation.