The primary objective is to demonstrate that the Rotigotine transdermal patch is efficacious in Chinese subjects with early-stage idiopathic Parkinson's disease.
The study includes a maximum 4-week Screening Period, a maximum 4-week Titration Period for early-stage Parkinson's disease 24-week Maintenance Period, a maximum 6-day De-escalation Period and 30-day Safety Follow-Up Period. The maximum study durations for an individual subject with early-stage Parkinson's disease will be 36 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
249
Transdermal Patch Content: 2 mg /24 h (10 cm\^2), 4 mg /24 h (20 cm\^2), 6 mg /24 h (30 cm\^2), 8 mg /24 h (40 cm\^2) For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period
Transdermal Patch Size: 10 cm\^2, 20 cm\^2, 30 cm\^2, 40 cm\^2 Subjects randomized to placebo will receive matching placebo patches
001
Beijing, China
002
Beijing, China
019
Beijing, China
Change in the Sum of the Score From the Activities of Daily Living (ADL) Scale and Motor Examination in the Unified Parkinson's Disease Rating Scale (UPDRS) (Parts II+III, a UPDRS Subtotal) From Baseline to the End of Double-blind Maintenance Period
The UPDRS assessments (Parts II+III) will be performed at every visit. For the assessment of the subject's disability, Part II of the UPDRS will be used. Data will be gathered pertaining to the subject's disease state in the "on" state. Subjects will respond to questions about their general state in the week prior to their scheduled visit in conjunction with any observations made by the investigator (or designee). For the assessment of the subject's motor function, Part III of the UPDRS will be used and the assessments will be done while the subject is in the "on" state. The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score is calculated as sum of these 27 individual scores. The sum score ranges from 0 to 160, higher scores denote greater disability.
Time frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 24)
Response to Therapy, Defined as ≥20 % Decrease in the Sum of Scores From Activities of Daily Living (ADL) & Motor Examination in Unified Parkinson's Disease Rating Scale (UPDRS Parts II+III, a UPDRS Subtotal) From Baseline to End of Maintenance Period
The UPDRS assessments (Parts II+III) will be performed at every visit. For the assessment of the subject's disability, Part II of the UPDRS will be used. Data will be gathered pertaining to the subject's disease state in the "on" state. Subjects will respond to questions about their general state in the week prior to their scheduled visit in conjunction with any observations made by the investigator (or designee). For the assessment of the subject's motor function, Part III of the UPDRS will be used and the assessments will be done while the subject is in the "on" state. The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score is calculated as sum of these 27 individual scores. A higher score denotes greater disability.
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025
Beijing, China
017
Changchun, China
007
Chengdu, China
027
Chengdu, China
021
Fuzhou, China
010
Guangzhou, China
011
Guangzhou, China
...and 14 more locations
Time frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 24)
Change in Unified Parkinson's Disease Rating Scale [UPDRS Part II (ADL)] From Baseline to the End of the Double-blind Maintenance Period
The UPDRS assessments (Parts II+III) will be performed at every visit. For the assessment of the subject's disability, Part II of the UPDRS will be used. Data will be gathered pertaining to the subject's disease state in the "on" state. Subjects will respond to questions about their general state in the week prior to their scheduled visit in conjunction with any observations made by the investigator (or designee). The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The sum score ranges from 0 to 52, higher scores denote greater disability.
Time frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 24)
Change in Unified Parkinson's Disease Rating Scale [UPDRS Part III (Motor Examination)] From Baseline to the End of the Double-blind Maintenance Period
The UPDRS assessments (Parts II+III) will be performed at every visit. For the assessment of the subject's motor function, Part III of the UPDRS will be used and the assessments will be done while the subject is in the "on" state. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score ranges from 0 to 108, higher scores denote greater disability.
Time frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 24)