CR FIRST (Sinemet® CR Five Year International Response Fluctuation Study) is a multicentre clinical trial (currently in its fifth year of implementation) designed to test the hypothesis that long term treatment of patients with Parkinson’s disease with a controlled-release formulation of levodopa (Sinemet® CR) will extend the time until the onset of clinical response fluctuations. CR FIRST was designed with sufficient power to detect a clinically significant treatment effect, if one exists. A total of 618 levodopa-natïve patients with Parkinson’s disease, who required therapy with levodopa, were enrolled at 36 sites throughout the world. Patients were randomised to receive 1 tablet twice a day of either immediate-release Sinemet® 25/100 (carbidopa/levodopa) or Sinemet® CR 50/200, then titrated according to response. Patients are being evaluated at regular intervals over 5 years to determine if and when the primary end-point of response fluctuations is attained. At baseline, the cohort represented a moderately disabled patient population, as evidenced by an average Hoehn and Yahr state of 1.9 and an average duration since diagnosis of 2.3 years. As expected, the CR FIRST population had a higher degree of disease severity than patients in the Deprenyl and Tochopherol Antioxidative Therapy of Parkinsonism (DATATOP) cohort. The 2 populations were very similar with regard to demographic characteristics.
KeywordsLevodopa Adis International Limited Drug Invest Selegiline Motor Fluctuation
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