Enrollment complete in landmark ADAGIO trial

8 January 2007

The largest clinical trial to investigate disease modification in early Parkinson's disease has completed enrollment. The ADAGIO study is evaluating approximately 1,200 recently-diagnosed patients worldwide to determine if once-daily treatment with Israeli drugmaker Teva's Azilect (rasagiline tablets) can slow the progression of the neurodenegerative disorder. The study is expected to finish by the middle of 2008 and findings are scheduled for release later that year.

To date, there are no PD therapies on the market shown to slow, halt, or reverse the progression of this neurodegenerative disease for the one million people in the USA. The double-blind, placebo-controlled phase of the study includes two active treatment groups receiving either 1mg or 2mg doses of Azilect once daily, and one placebo-treated arm for 36 weeks. After that period, participants will either continue on their preassigned active treatment for another 36 weeks or, in the case of placebo patients, be switched to one of the two Azilect doses in a blinded fashion. Progression of PD will be assessed using the Total Score of the Unified Parkinson Disease Rating Scale during the last 36 weeks of the 72-week study.

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