- Total Score in the Japanese UPDRS Part III [ Time Frame: Weeks 0-52 ] [ Designated as safety issue: No ]
The Unified Parkinson's Disease Rating Scale (UPDRS) assesses the status of Parkinson's Disease (PD) patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.
- Change From Baseline in the Japanese UPDRS Part III [ Time Frame: Baseline (Week 0) and Weeks 1-52 ] [ Designated as safety issue: No ]
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.
- Percent Change From Baseline in the Japanese UPDRS Part III [ Time Frame: Baseline (Week 0) and Weeks 1-52 ] [ Designated as safety issue: No ]
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. A maximum total score is 108 points.The higher score indicates more severe PD symptoms.
- Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III [ Time Frame: Baseline (Week 0) and Weeks 1-52 ] [ Designated as safety issue: No ]
A responder is defined as a participant with a 30% or more reduction at baseline. The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.
- Total Score in the Japanese UPDRS Part I [ Time Frame: Weeks 0-52 ] [ Designated as safety issue: No ]
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per each item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.
- Change From Baseline in the Japanese UPDRS Part I [ Time Frame: Baseline (Week 0) and Weeks 1-52 ] [ Designated as safety issue: No ]
The UPDRS (Unified Parkinson's Disease Rating Scale) assesses the status of PD patients objectively. The Japanese UPDRS Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per each item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.
- Percent Change From Baseline in the Japanese UPDRS Part I [ Time Frame: Baseline (Week 0) and Weeks 1-52 ] [ Designated as safety issue: No ]
The UPDRS (Unified Parkinson's Disease Rating Scale) assesses the status of PD patients objectively. The Japanese UPDRS Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per each item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.
- Total Score in the Japanese UPDRS Part II [ Time Frame: Weeks 0-52 ] [ Designated as safety issue: No ]
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per each item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.
- Change From Baseline in the Japanese UPDRS Part II [ Time Frame: Baseline (Week 0) and Weeks 1-52 ] [ Designated as safety issue: No ]
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per each item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.
- Percent Change From Baseline in the Japanese UPDRS Part II [ Time Frame: Baseline (Week 0) and Weeks 1-52 ] [ Designated as safety issue: No ]
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per each item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.
- Total Score in the Japanese UPDRS Part IV [ Time Frame: Baseline (Week 0) and Weeks 0-52 ] [ Designated as safety issue: No ]
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per each item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.
- Change From Baseline in the Japanese UPDRS Part IV [ Time Frame: Baseline (Week 0) and Weeks 1-52 ] [ Designated as safety issue: No ]
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per each item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.
- Percent Change From Baseline in the Japanese UPDRS Part IV [ Time Frame: Baseline (Week 0) and Weeks 1-52 ] [ Designated as safety issue: No ]
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per each item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.
- Summary of the Modified Hoehn & Yahr Criteria Stages [ Time Frame: Screening-Week 52 ] [ Designated as safety issue: No ]
Hoehn & Yahr criteria were measured on an 8-point scale. 0: No signs of disease, 1: Unilateral disease, 1.5: Unilateral plus axial involvement, 2: Bilateral disease, 2.5: Mild bilateral disease, 3: Mild to moderate bilateral disease. No subjects evaluated had a score of 4 (severe disability) or 5 (wheelchair bound or bedridden unless aided).
- Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale [ Time Frame: Weeks 1-52 ] [ Designated as safety issue: No ]
CGI is measured on a 7-point scale. 1: Very much improved, 2: Much Improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse. Responders are defined as those participants scored as "very much improved" or "much improved."
- Percentage of Participants Who Remained in the Study on the Indicated Days [ Time Frame: Days 0-364 ] [ Designated as safety issue: No ]
The percentage of participants remaining in the study was examined using the Kaplan-Meier method, in which a premature discontinuation will be considered as an event.
- Change From Baseline in Albumin, Total Protein, and Hemoglobin at Weeks 16 and 52 [ Time Frame: Baseline (Screening) and Weeks 16 and 52 ] [ Designated as safety issue: No ]
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
- Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52 [ Time Frame: Baseline (Screening) and Weeks 16 and 52 ] [ Designated as safety issue: No ]
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
- Change From Baseline in Total Bilirubin, Blood Urea Nitrogen, and Creatinine at Weeks 16 and 52 [ Time Frame: Baseline (Screening) and Weeks 16 and 52 ] [ Designated as safety issue: No ]
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
- Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52 [ Time Frame: Baseline (Screening) and Weeks 16 and 52 ] [ Designated as safety issue: No ]
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
- Change From Baseline in Prolactin at Weeks 16 and 52 [ Time Frame: Baseline (Screening) and Weeks 16 and 52 ] [ Designated as safety issue: No ]
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
- Change From Baseline in Hematocrit at Weeks 16 and 52 [ Time Frame: Baseline (Screening) and Weeks 16 and 52 ] [ Designated as safety issue: No ]
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
- Change From Baseline in Platelet Count and White Blood Cell Count at Weeks 16 and 52 [ Time Frame: Baseline (Screening) and Weeks 16 and 52 ] [ Designated as safety issue: No ]
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
- Change From Baseline in Red Blood Cell Count at Weeks 16 and 52 [ Time Frame: Baseline (Screening) and Weeks 16 and 52 ] [ Designated as safety issue: No ]
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
- Urinalysis Data [ Time Frame: Screening, Week 16, and Week 52 ] [ Designated as safety issue: No ]
The number of participants with the indicated dipstick test values were measured. Dipstick test values: Neg Value, Trace, +1, +2, +3, +4. No participants had a score of +5.
- Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 [ Time Frame: Baseline (Screening) and Weeks 16 and 52 ] [ Designated as safety issue: No ]
Baseline Finding/Time Period Finding. Abbreviations: N = normal; A = abnormal; CS = clinically significant; NCS = not clinically significant. Options include N/N, N/ANCS, N/ACS, ANCS/N, ANCS/ANCS, ANCS/ACS, ACS/N, ACS/ANCS, and ACS/ACS.
- Change From Baseline in Supine and Standing Systolic and Diastolic Blood Pressure at Weeks 16 and 52 [ Time Frame: Baseline (Screening) and Weeks 16 and 52 ] [ Designated as safety issue: No ]
Change from baseline was calculated as Week 16 and Week 52 values minus baseline values.
- Change From Baseline in Supine and Standing Pulse Rate at Weeks 16 and 52 [ Time Frame: Baseline (Screening) and Weeks 16 and 52 ] [ Designated as safety issue: No ]
Change from baseline was calculated as Week 16 and Week 52 values minus baseline values.
Purpose
