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Pharma & Bio Ingredients
To date, there are no PD therapies on the market shown to slow, halt, or reverse the progression of this neurodegenerative disease for the 1 million people in the United States suffering from Parkinson's disease. PD continues to challenge researchers. Its symptoms can ultimately rob patients of everyday freedoms, like walking and maintaining control of movement. "The ADAGIO study is designed to separate the symptomatic improvement from any potential disease modifying activity," said Dr. Warren Olanow, professor and chairman of the Department of Neurology at Mount Sinai School of Medicine.
The double-blind, placebo-controlled phase of the study includes two active treatment groups receiving either 1 mg or 2 mg doses of Azilect once daily, and one placebo-treated group for 36 weeks. After that period, study 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 treatment doses in a blinded fashion. Progression of PD will be assessed using the Total Score of the Unified Parkinson Disease Rating Scale (UPDRS) during the last 36 weeks of the 72-week study.
The study is expected to be completed by mid 2008 and findings are expected to be made public later that year.
Azilect was approved by the Food & Drug Administration May 17, 2006, based on data from three multicenter, multinational, double-blind, randomized, placebo-controlled, clinical studies, which included more than 1,500 patients.
