Trial Outcomes & Findings for Placebo-controlled Study in Patients With Parkinson's Disease to Evaluate the Effect of Rotigotine on Non-motor Symptoms (NCT NCT01300819)
NCT ID: NCT01300819
Last Updated: 2014-05-09
Results Overview
The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in the following 9 domain categories: cardiovascular, including falls; sleep/fatigue; mood/cognition; perceptual problems/hallucinations; attention/memory; gastrointestinal tract; urinary; sexual function; miscellaneous. Severity and frequency are rated using a 4-point scale ranging from 0 (none) to 3 (severe; major source of distress or disturbance to subject) for severity and from 1 (rarely) to 4 (very frequent \[daily or all the time\]) for frequency. The total NMSS score ranges from 0 to 350. A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.
COMPLETED
PHASE4
349 participants
From Baseline (Day 1) to end of 12-week Maintenance (Day 84)
2014-05-09
Participant Flow
The study was conducted in 71 sites spread across 12 countries, with 349 subjects randomized. The study duration per subject was up to 29 weeks. The Participant Flow consists of patients in the Enrolled Set (ES). The Enrolled Set (ES) includes all subjects who signed the Informed Consent Form.
Eligibility was assessed during the Screening Period, which lasted up to 4 weeks prior to the Baseline Visit. Eligible subjects returned for a Baseline Visit, during which all Baseline assessments were performed and then the subject was randomized to either Rotigotine or Placebo.
Participant milestones
| Measure |
Placebo
Placebo : Placebo patches of 2, 4, 6 \& 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
Rotigotine
Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
224
|
|
Overall Study
COMPLETED
|
103
|
180
|
|
Overall Study
NOT COMPLETED
|
22
|
44
|
Reasons for withdrawal
| Measure |
Placebo
Placebo : Placebo patches of 2, 4, 6 \& 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
Rotigotine
Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
27
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
10
|
12
|
|
Overall Study
Patient was 1 month late for Visit 10
|
0
|
1
|
|
Overall Study
Refusal to down titrate study drug
|
0
|
1
|
|
Overall Study
Administrative reason
|
0
|
1
|
|
Overall Study
Safety follow up not done by mistake
|
0
|
1
|
|
Overall Study
Follow up call was not done
|
1
|
0
|
Baseline Characteristics
Placebo-controlled Study in Patients With Parkinson's Disease to Evaluate the Effect of Rotigotine on Non-motor Symptoms
Baseline characteristics by cohort
| Measure |
Placebo
n=125 Participants
Placebo : Placebo patches of 2, 4, 6 \& 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
Rotigotine
n=224 Participants
Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
Total
n=349 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.6 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
68.0 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
67.5 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Age, Customized
< 65 years
|
51 participants
n=5 Participants
|
74 participants
n=7 Participants
|
125 participants
n=5 Participants
|
|
Age, Customized
>= 65 years
|
74 participants
n=5 Participants
|
150 participants
n=7 Participants
|
224 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
8 participants
n=5 Participants
|
11 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
8 participants
n=5 Participants
|
13 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
15 participants
n=5 Participants
|
28 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
12 participants
n=5 Participants
|
23 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
4 participants
n=5 Participants
|
9 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
18 participants
n=5 Participants
|
36 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
30 participants
n=5 Participants
|
51 participants
n=7 Participants
|
81 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
15 participants
n=5 Participants
|
24 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
9 participants
n=5 Participants
|
19 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Weight
|
77.52 kilogram
STANDARD_DEVIATION 14.90 • n=5 Participants
|
76.97 kilogram
STANDARD_DEVIATION 13.66 • n=7 Participants
|
77.16 kilogram
STANDARD_DEVIATION 14.10 • n=5 Participants
|
|
Height
|
167.42 centimeter
STANDARD_DEVIATION 10.17 • n=5 Participants
|
168.54 centimeter
STANDARD_DEVIATION 8.56 • n=7 Participants
|
168.14 centimeter
STANDARD_DEVIATION 9.17 • n=5 Participants
|
|
Body Mass Index (BMI)
|
27.593 kilogram per square meter
STANDARD_DEVIATION 4.505 • n=5 Participants
|
27.047 kilogram per square meter
STANDARD_DEVIATION 4.348 • n=7 Participants
|
27.243 kilogram per square meter
STANDARD_DEVIATION 4.406 • n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)Population: This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.
The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in the following 9 domain categories: cardiovascular, including falls; sleep/fatigue; mood/cognition; perceptual problems/hallucinations; attention/memory; gastrointestinal tract; urinary; sexual function; miscellaneous. Severity and frequency are rated using a 4-point scale ranging from 0 (none) to 3 (severe; major source of distress or disturbance to subject) for severity and from 1 (rarely) to 4 (very frequent \[daily or all the time\]) for frequency. The total NMSS score ranges from 0 to 350. A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.
Outcome measures
| Measure |
Placebo
n=120 Participants
Placebo : Placebo patches of 2, 4, 6 \& 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
Rotigotine
n=207 Participants
Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
|---|---|---|
|
Change From Baseline to the End of Maintenance in Total Nonmotor Symptoms Scale (NMSS) Score
|
-19.1 scores on a scale
Standard Deviation 24.2
|
-23.1 scores on a scale
Standard Deviation 23.4
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)Population: This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.
The Unified Parkinson's Disease Rating Scale (UPDRS) Part III is a scale for the assessment of function in Parkinson's Disease. UPDRS Part III measures Motor Function. It consists of 14 items with 27 questions, each ranging from 0 to 4. The sum score for the UPDRS Part III ranges from 0 to 108. A higher score indicates greater disability. A negative change from Baseline to end of Maintenance score indicates improvement.
Outcome measures
| Measure |
Placebo
n=120 Participants
Placebo : Placebo patches of 2, 4, 6 \& 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
Rotigotine
n=206 Participants
Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
|---|---|---|
|
Change From Baseline to the End of Maintenance in Total Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score
|
-3.6 scores on a scale
Standard Deviation 8.3
|
-5.7 scores on a scale
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)Population: This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.
Parkinson's Disease Questionnaire - 39 (PDQ-39) is a self-administered questionnaire. It comprises of 39 questions, relating to eight key areas of health and daily activities, including both Motor and Non-motor symptoms. It is scored on a scale of zero to 100, with lower scores indicating better health and high scores more severe symptoms in change from Baseline to end of Maintenance.
Outcome measures
| Measure |
Placebo
n=116 Participants
Placebo : Placebo patches of 2, 4, 6 \& 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
Rotigotine
n=204 Participants
Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
|---|---|---|
|
Change From Baseline to the End of Maintenance in Health-related Quality of Life (HRQL) Measured by a 39-item Parkinson's Disease Questionnaire (PDQ-39)
|
-2.6 scores on a scale
Standard Deviation 12.5
|
-5.9 scores on a scale
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)Population: This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.
The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (\<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale. The final score is derived from multiplying the severity score and the frequency score. A negative change from Baseline to end of Maintenance indicates an improvement in NMSS. The possible min/max final scores per subdomain are calculated as follows: Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain: Subdomain Cardiovascular (2 questions): range 0 - 24
Outcome measures
| Measure |
Placebo
n=120 Participants
Placebo : Placebo patches of 2, 4, 6 \& 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
Rotigotine
n=207 Participants
Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
|---|---|---|
|
Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Cardiovascular
|
-1.2 scores on a scale
Standard Deviation 2.8
|
-1.1 scores on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)Population: This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.
The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (\<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale. The final score is derived from multiplying the severity score and the frequency score. A negative change from Baseline to end of Maintenance indicates an improvement in NMSS. The possible min/max final scores per subdomain are calculated as follows: Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain: Subdomain Sleep/Fatigue (4 questions): range 0-48
Outcome measures
| Measure |
Placebo
n=120 Participants
Placebo : Placebo patches of 2, 4, 6 \& 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
Rotigotine
n=207 Participants
Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
|---|---|---|
|
Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Sleep/Fatigue
|
-3.9 scores on a scale
Standard Deviation 5.9
|
-5.4 scores on a scale
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)Population: This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.
The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (\<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale. The final score is derived from multiplying the severity score and the frequency score. A negative change from Baseline to end of Maintenance indicates an improvement in NMSS. The possible min/max final scores per subdomain are calculated as follows: Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain: Subdomain Mood/Cognition (6 questions): range 0 - 72
Outcome measures
| Measure |
Placebo
n=120 Participants
Placebo : Placebo patches of 2, 4, 6 \& 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
Rotigotine
n=207 Participants
Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
|---|---|---|
|
Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Mood/Cognition
|
-5.1 scores on a scale
Standard Deviation 10.0
|
-6.6 scores on a scale
Standard Deviation 11.0
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)Population: This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.
The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (\<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale. The final score is derived from multiplying the severity score and the frequency score. A negative change from Baseline to end of Maintenance indicates an improvement in NMSS. The possible min/max final scores per subdomain are calculated as follows: Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain: Subdomain Perception/Hallucinations (3 questions): range 0 - 36
Outcome measures
| Measure |
Placebo
n=120 Participants
Placebo : Placebo patches of 2, 4, 6 \& 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
Rotigotine
n=207 Participants
Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
|---|---|---|
|
Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Perception/Hallucinations
|
-0.2 scores on a scale
Standard Deviation 1.8
|
-0.2 scores on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)Population: This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.
The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (\<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale. The final score is derived from multiplying the severity score and the frequency score. A negative change from Baseline to end of Maintenance indicates an improvement in NMSS. The possible min/max final scores per subdomain are calculated as follows: Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain: Subdomain Attention/Memory (3 questions): range 0 - 36
Outcome measures
| Measure |
Placebo
n=120 Participants
Placebo : Placebo patches of 2, 4, 6 \& 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
Rotigotine
n=207 Participants
Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
|---|---|---|
|
Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Attention/Memory,
|
-1.3 scores on a scale
Standard Deviation 4.8
|
-1.5 scores on a scale
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)Population: This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.
The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (\<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale. The final score is derived from multiplying the severity score and the frequency score. A negative change from Baseline to end of Maintenance indicates an improvement in NMSS. The possible min/max final scores per subdomain are calculated as follows: Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain: Subdomain Gastrointestinal tract (3 questions): range 0 - 36
Outcome measures
| Measure |
Placebo
n=120 Participants
Placebo : Placebo patches of 2, 4, 6 \& 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
Rotigotine
n=207 Participants
Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
|---|---|---|
|
Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Gastrointestinal Tract
|
-1.4 scores on a scale
Standard Deviation 3.4
|
-1.6 scores on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)Population: This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.
The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (\<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale. The final score is derived from multiplying the severity score and the frequency score. A negative change from Baseline to end of Maintenance indicates an improvement in NMSS. The possible min/max final scores per subdomain are calculated as follows: Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain: Subdomain Urinary (3 questions): range 0 - 36
Outcome measures
| Measure |
Placebo
n=120 Participants
Placebo : Placebo patches of 2, 4, 6 \& 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
Rotigotine
n=207 Participants
Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
|---|---|---|
|
Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Urinary
|
-2.7 scores on a scale
Standard Deviation 6.6
|
-2.4 scores on a scale
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)Population: This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.
The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (\<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale. The final score is derived from multiplying the severity score and the frequency score. A negative change from Baseline to end of Maintenance indicates an improvement in NMSS. The possible min/max final scores per subdomain are calculated as follows: Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain: Subdomain Sexual function (2 questions): range 0 - 24
Outcome measures
| Measure |
Placebo
n=120 Participants
Placebo : Placebo patches of 2, 4, 6 \& 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
Rotigotine
n=207 Participants
Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
|---|---|---|
|
Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Sexual Function
|
-1.2 scores on a scale
Standard Deviation 4.2
|
-1.1 scores on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)Population: This analysis was performed according to the Full Analysis Set (FAS), which is defined as all treated subjects with a baseline and post-baseline NMSS measure, and follows the intention-to-treat principle.
The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in 9 different domains. Severity (ranges: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) and frequency (ranges: 1 = Rarely (\<1/wk), 2 = Often (1/wk), 3 = Frequent (several times per week), 4 = Very Frequent (daily or all the time) are rated using a 4-point scale. The final score is derived from multiplying the severity score and the frequency score. A negative change from Baseline to end of Maintenance indicates an improvement in NMSS. The possible min/max final scores per subdomain are calculated as follows: Range of final score per subdomain: 0 - 12 per question multiplied by the number of questions per subdomain: Subdomain Miscellaneous (4 questions): range 0 - 48
Outcome measures
| Measure |
Placebo
n=120 Participants
Placebo : Placebo patches of 2, 4, 6 \& 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
Rotigotine
n=207 Participants
Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
|---|---|---|
|
Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Miscellaneous
|
-2.2 scores on a scale
Standard Deviation 4.4
|
-3.2 scores on a scale
Standard Deviation 5.7
|
Adverse Events
Placebo
Rotigotine
Serious adverse events
| Measure |
Placebo
n=125 participants at risk
Placebo : Placebo patches of 2, 4, 6 \& 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
Rotigotine
n=223 participants at risk
Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
|---|---|---|
|
Cardiac disorders
Heart failure
|
0.00%
0/125 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
0.45%
1/223 • Number of events 1 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
|
General disorders
Death
|
0.80%
1/125 • Number of events 1 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
0.00%
0/223 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.80%
1/125 • Number of events 1 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
0.00%
0/223 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
|
Infections and infestations
Urinary tract infection
|
0.80%
1/125 • Number of events 1 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
0.00%
0/223 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
|
Nervous system disorders
Acute cerebral infarction
|
0.80%
1/125 • Number of events 1 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
0.00%
0/223 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
|
Nervous system disorders
Hemiparesis
|
0.80%
1/125 • Number of events 1 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
0.00%
0/223 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.80%
1/125 • Number of events 1 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
0.00%
0/223 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.00%
0/125 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
0.45%
1/223 • Number of events 1 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/125 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
0.45%
1/223 • Number of events 1 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/125 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
0.45%
1/223 • Number of events 1 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/125 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
0.45%
1/223 • Number of events 1 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
|
Nervous system disorders
Diabetic coma
|
0.00%
0/125 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
0.45%
1/223 • Number of events 1 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/125 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
0.45%
1/223 • Number of events 1 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.00%
0/125 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
0.45%
1/223 • Number of events 1 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
|
Cardiac disorders
Artrial Fibrillation + Chest pain
|
0.00%
0/125 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
0.45%
1/223 • Number of events 1 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
|
Nervous system disorders
Worsening of Parkinson's Disease
|
0.00%
0/125 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
0.45%
1/223 • Number of events 1 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
|
Cardiac disorders
Exacerbation of chronic left sided heart insufficiency
|
0.80%
1/125 • Number of events 1 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
0.00%
0/223 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
Other adverse events
| Measure |
Placebo
n=125 participants at risk
Placebo : Placebo patches of 2, 4, 6 \& 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
Rotigotine
n=223 participants at risk
Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
5.6%
7/125 • Number of events 8 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
12.1%
27/223 • Number of events 30 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
|
General disorders
Application site pruritus
|
1.6%
2/125 • Number of events 3 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
6.7%
15/223 • Number of events 16 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
|
General disorders
Fatigue
|
5.6%
7/125 • Number of events 8 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
4.0%
9/223 • Number of events 10 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
|
Nervous system disorders
Somnolence
|
5.6%
7/125 • Number of events 8 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
8.1%
18/223 • Number of events 21 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
|
Nervous system disorders
Dizziness
|
7.2%
9/125 • Number of events 9 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
6.7%
15/223 • Number of events 15 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
|
Nervous system disorders
Headache
|
4.0%
5/125 • Number of events 5 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
5.4%
12/223 • Number of events 14 • Adverse Events were collected during 16 weeks (from Baseline to Safety Follow up Visit).
The Analysis Population refers to the Safety Set (SS). The SS consists of all randomized subjects receiving at least 1 dose of Investigational Medicinal Product (IMP).
|
Additional Information
UCB Clinical Trial Call Center
UCB
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60