Parkinson Disease Clinical Trial
Official title:
A Clinical Study to Determine the Optimal Dose of WIN-1001X by Evaluating Its Efficacy and Safety in Patients With Early Parkinson's Disease: Double-blind, Randomized, Placebo-controlled, Multicenter, Phase II Study
The purpose of this study is to determine the optimal dose of WIN-1001X for its therapeutic confirmatory study by comparing and evaluating the efficacy and safety of each dose group by conducting a therapeutic exploratory study on three dose groups of WIN-1001X 400 mg, 800 mg, and 1200 mg, and placebo group in patients with early Parkinson's disease.
The primary objective of this study is to evaluate the difference in the change of MDS UPDRS Part Ⅲ between WIN-1001X 400 mg, 800 mg, and 1200 mg as the test drugs compared to placebo as the control drug after administering them for 12 weeks. The secondary objectives of this study are to evaluate the therapeutic efficacy and safety of the 3 dose groups of WIN-1001X compared to placebo group by assessing the changes in MDS UPDRS Part Ⅲ after administering the investigational products for 4 and 8 weeks, the changes in MDS UPDRS Part Ⅰ, Part Ⅱ, Part Ⅰ+Part Ⅱ+Part Ⅲ, and Modified Hoehn and Yahr scale after administering for 4, 8, and 12 weeks, the changes in K-NMSS (Non-Motor Symptoms Scale), K-MoCA (Korean-Montreal Cognitive Assessment), K-PDQ-39 (Parkinson's Disease Questionnaire) score. ;
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