A Long Term, Double-blind, Randomized, Parallel-group, Carbidopa/levodopa Controlled, Multicenter Study to Evaluate the Effect of Stalevo in Patients with Parkinson’s Disease Requiring Initiation of Levodopa Therapy

Investigators:
Charles H. Adler, M.D., Ph.D., John N. Caviness, M.D., and Vigilio G. H. Evidente, M.D.

Study Sponsor and Phase:
Novartis/Orion Pharma; Phase IIIb study of a FDA approved drug

Study Centers:
Approximately 70 centers in the US and Europe will participate. A total of 740 Parkinson’s disease patients will be enrolled in this study with up to 10 patients being enrolled at MCS.

Duration of Study:
Patients will be followed for a minimum of 104 weeks and a maximum of 156 weeks.

Primary Objective:
To assess whether Stalevo (carbidopa/levodopa/entacapone) results in a reduced occurrence of dyskinesias compared with carbidopa/levodopa (Sinemet).

Secondary Objectives:
To assess the differences in efficacy of carbidopa/levodopa and Stalevo as regards, PD rating scales, dyskinesias, wearing off, quality of life, and pharmacogenetics. To assess the safety of carbidopa/levodopa and Stalevo.

Rationale:
This study is designed to compare the occurrence of dyskinesias and the efficacy of two FDA approved treatments for patients with PD. It is currently unclear whether the addition of entacapone, a drug that increases the bioavailability of levodopa, has any advantage in early PD. By comparing the treatment of early PD cases with carbidopa/levodopa vs. carbidopa/levodopa/entacapone, this study should answer this question. Theoretically, the more prolonged the availability of levodopa, and the less fluctuation in plasma levodopa levels, the less likely patients will develop dyskinesias.

Methodology:
Approximately 740 PD subjects will be enrolled and be in the study for 104 to 156 weeks.