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Schering-Plough Reports Preladenant Meets Primary Endpoint in Phase II Dose-Finding Trial for Parkinson's Disease
Date:11/24/2008

KENILWORTH, N.J., Nov. 24 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today reported that preladenant, its novel and selective adenosine2a receptor antagonist, met the primary endpoint in a Phase II dose-finding trial in patients suffering from moderate to severe Parkinson's disease experiencing motor fluctuations and abnormal involuntary movements (dyskinesias). The trial results were presented today at the company's 2008 R&D Update meeting being hosted for analysts and portfolio managers at company headquarters.

The dose-finding study was a randomized, placebo-controlled, double-blind, multicenter, multinational clinical trial that evaluated the efficacy and safety of four different doses (1, 2, 5 or 10 mg BID) of preladenant compared to placebo in the treatment of patients with moderate to severe Parkinson's disease with motor fluctuations and dyskinesias. All patients were on a stable regimen of standard treatments with L-DOPA and other adjunctive treatments, such as dopamine agonists and/or entacapone, but were still experiencing motor fluctuations and dyskinesias. The previous treatment was continued throughout the trial, in which the study medication was given as an adjunctive therapy.

A total of 253 patients were randomized into the trial, with the treatment phase lasting 12 weeks. Preladenant was statistically significantly more effective than the control group at the doses of 5 and 10 mg BID, respectively, in reducing the "off"-time, the primary endpoint of the trial.

In addition, preladenant significantly increased the "on"-time at the same doses of 5 and 10 mg BID, a secondary endpoint of the study. Importantly, this improvement in "on"-time was not associated with a proportional overall increase in dyskinesias. Preladenant was found to be safe and well tolerated.
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