The primary objective of this study is to determine the recommended dose and evaluate the effect of KW-6356 on motor symptoms in Parkinson's disease and the primary endpoint is the change from baseline in Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) partIII score between KW-6356 and placebo in patients with Parkinson's disease on treatment with Levodopa-containing preparations as an adjunctive therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
502
Iwamizawa Neurology Clinic
Iwamizawa, Hokkaido, Japan
Change from baseline in the Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) part III score
MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The scales are now titled; (Part I) nonmotor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The total score is the sum of the subscale scores for Parts III and ranges from 0 (no disability) to 136 (total dependence).
Time frame: Up to 26 weeks after dosing
Change from baseline in the total hours of awake time per day spent in the OFF state. (total hours per day spent in the OFF state)
Time frame: Up to 26 weeks after dosing
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