The primary objective is to evaluate the effect of KW-6356 on motor symptoms in Parkinson's disease and the primary endpoint is the change from baseline in the MDS-UPDRS part III score between KW-6356 and placebo in subjects with early Parkinson's disease in Japan.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
175
Unnamed facility
Asahikawa, Hokkaido, Japan
Unnamed facility
Akashi, Hyōgo, Japan
Unnamed facility
Fujisawa, Kanagawa, Japan
Unnamed facility
Suita, Osaka, Japan
Unnamed facility
Change from baseline in the Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) partⅢ score
Time frame: Up to 12 weeks after dosing
Clinical global impression-improvement(CGI-I) score
Time frame: Week 12
Patient global impression-improvement(PGI-I) score
Time frame: Week 12
Change from baseline in the Parkinson's disease questionnaire-39(PDQ-39) total scores
Time frame: Up to 12 weeks after dosing
Number and percentage of subjects with treatment-emergent adverse events
Time frame: Up to 14 weeks after dosing
Profiles of pharmacokinetics of plasma KHK6356 concentration
Time frame: 2, 4, 8 and 12 weeks after dosing
Change from baseline in the MDS-UPDRS subitem and total scores
Time frame: Up to 12 weeks after dosing
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Nakano City, Tokyo, Japan
Unnamed facility
Setagaya City, Tokyo, Japan
Unnamed facility
Kyoto, Japan