The primary objective of this study was to demonstrate that Rotigotine transdermal patch is efficacious in Chinese subjects with advanced-stage Idiopathic Parkinson's Disease as an adjuvant therapy.
The study included a maximum 4-week Screening Period, a maximum 7-week Titration Period for advanced-stage Parkinson's disease, 12-week Maintenance Period, a maximum 12-day De-escalation Period for advanced-stage Parkinson's Disease and 30-day Safety Follow-Up Period. The maximum study duration for an individual subject with advanced-stage Parkinson's disease was 27 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
346
Transdermal Patch Content: 4 mg /24 h (20 cm\^2), 6 mg /24 h (30 cm\^2), 8 mg /24 h (40 cm\^2) For advanced-stage Parkinson's Disease, subjects received Rotigotine patches in escalating weekly dose (starting with daily doses 4 mg/24 h to 16 mg/24 h) for a maximum 7-week Titration Period, then 12 week maintenance period
Transdermal Patch Size: 20 cm\^2, 30 cm\^2, 40 cm\^2 Subjects randomized to placebo received matching placebo patches
Subject must be on a stable dose of L-dopa (either short-acting or sustained release \[in combination with benserazide or carbidopa\]) of at least 200 mg/day, administered in at least 2 intakes, for at least 28 days prior to Baseline.
Sp1037 001
Beijing, China
Sp1037 002
Beijing, China
Sp1037 019
Absolute Change in Absolute Time Spent 'Off' From Baseline to the End of Double-blind Maintenance Period
A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication. A negative mean indicates a reduction of the time off during the conduct of the study
Time frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)
Percentage of Responders From Baseline to the End of the Doubleblind Maintenance Period
A Responder is defined as a subject with an ≥ 30 % decrease in absolute time spent 'off'
Time frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)
Percent Change in Absolute Time Spent "Off" From Baseline to the End of Double-blind Maintenance Period
A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication. Absolute time "off" is defined as the mean number of hours marked "off" during a 24-hour period from all valid daily diary cards.
Time frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)
Percent Change in Relative Time Spent "Off" From Baseline to the End of Double-blind Maintenance Period
A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication. Relative time spent "off" will be calculated in two stages. Each valid daily diary will have an associated relative time "off" calculated as relative time "off" for day = 100\*\[total absolute time "off" for day/ absolute time awake for day\]. Relative time spent "off" is then calculated by averaging the daily relative time "off" for the valid days of that visit.
Time frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)
Change in Absolute Time Spent "on" From Baseline to the End of Double-blind Maintenance Period
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Beijing, China
Sp1037 025
Beijing, China
Sp1037 017
Changchun, China
Sp1037 007
Chengdu, China
Sp1037 027
Chengdu, China
Sp1037 021
Fuzhou, China
Sp1037 010
Guangzhou, China
Sp1037 011
Guangzhou, China
...and 14 more locations
A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'. Absolute time "on" is defined as the mean number of hours marked "on" during a 24-hour period from all valid daily diary cards.
Time frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)
Change in Relative Time Spent "on" From Baseline to the End of Double-blind Maintenance Period
A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was "off" when taking his/her L-dopa, he/she recorded the exact time their status changed to "on". Relative time spent "on" will be calculated in two stages. Each valid daily diary will have an associated relative time "on" calculated as relative time "on" for day = 100\*\[total absolute time "on" for day/ absolute time awake for day\]. Relative time spent "on" is then calculated by averaging the daily relative time "on" for the valid days of that visit.
Time frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)
Percent Change in Absolute Time Spent "on" From Baseline to the End of Double-blind Maintenance Period
A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'. Note for percent change calculations: when absolute time at Baseline was 0 hours, the absolute Baseline value was assumed to be 1 minute for calculation purposes.
Time frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)
Percent Change in Relative Time Spent "on" From Baseline to the End of Double-blind Maintenance Period
A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was "off" when taking his/her L-dopa, he/she recorded the exact time their status changed to "on". Note for percent change calculations: when relative time at Baseline was 0%, the relative Baseline value was assumed to be 0.1 for calculation purposes. Relative time spent "on" will be calculated in two stages. Each valid daily diary will have an associated relative time "on" calculated as relative time "on" for day = 100\*\[total absolute time "on" for day/ absolute time awake for day\]. Relative time spent "on" is then calculated by averaging the daily relative time "on" for the valid days of that visit.
Time frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)
Change in the Number of "Off" Periods From Baseline to the End of Double-blind Maintenance Period
A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication.
Time frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)
Change in Status of the Subject (on) After Wake-up With Troublesome Dyskinesia From Baseline to the End of Double-blind Maintenance Period
A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'. The percentage of days from Baseline to the end of the double-blind Maintenance Period in which the subject woke in the "on with troublesome dyskinesia" state is presented below.
Time frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)
Change in Status of the Subject (on) After Wake-up Without Troublesome Dyskinesia From Baseline to the End of Double-blind Maintenance Period
A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'. The percentage of days from Baseline to the end of the double-blind Maintenance Period in which the subject woke in the "on without troublesome dyskinesia" state is presented below.
Time frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)
Change in Status of the Subject (Off) After Wake-up From Baseline to the End of Double-blind Maintenance Period
A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication. The percentage of days from Baseline to the end of the double-blind Maintenance Period in which the subject woke in the "off" state is presented below.
Time frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)
Change in Unified Parkinson's Disease Rating Scale (UPDRS Part III Motor Examination) During "on" Periods From Baseline to the End of Double-blind Maintenance Period
The UPDRS Part III (motor subscale) assessment consists of 27 questions, measured on a 5-Point scale (0 to 4). The sum score is calculated as sum of these 27 individual questions. This score ranges from 0 to 108, higher scores denote greater disability. A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'.
Time frame: From Baseline (Week 0) to end of Maintenance Period (up to Week 12)