Long-term evaluation of Sinemet CR in parkinsonian patients with motor fluctuations.

The safety and efficacy of Sinemet CR, a controlled-release formulation of carbidopa/levodopa, were investigated in a three year, open-label trial involving 18 parkinsonian patients with fluctuating motor response. The average daily levodopa dosing frequency did not change significantly during long-term treatment. Efficacy measures generally revealed a gradual progression of parkinsonian disability. Patient diaries of motor fluctuations revealed relative stability of time "on" but with a tendency toward increased time "on with dyskinesias" over the 36 month follow-up period. There were no adverse laboratory results deemed to be related to Sinemet CR and no unexpected side effects were observed.