Trial Outcomes & Findings for Trial to Assess Parkinson's Disease (PD) Symptom Control to Four Doses of Rotigotine in a Transdermal Patch (NCT NCT00522379)
NCT ID: NCT00522379
Last Updated: 2014-10-27
Results Overview
Time "Off" is defined as when the patient does not have the effect of anti-Parkinson's medication.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
514 participants
Primary outcome timeframe
From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Results posted on
2014-10-27
Participant Flow
This Phase III study started in July 2007 with subjects from the United States, Mexico, Peru, Chile, and India. The primary completion date and study completion date occurred in July 2011. The Participant Flow and Baseline Characteristics are represenative of the Safety Set (SS), which is 514 subjects.
The study outcome measures are representative of the Full Analysis Set (FAS), which is 502 subjects. The Full Analysis Set (FAS) consisted of all subjects who were randomized, received at least 1 dose of study medication, and had a valid Baseline primary efficacy measurement and at least 1 valid post-Baseline primary efficacy measurement.
Participant milestones
| Measure |
Rotigotine 2 mg/24 hr
2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 4 mg/24 hr
4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 6 mg/24 hr
6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 8 mg/24 hr
8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Placebo
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
101
|
107
|
104
|
94
|
108
|
|
Overall Study
COMPLETED
|
79
|
84
|
82
|
80
|
81
|
|
Overall Study
NOT COMPLETED
|
22
|
23
|
22
|
14
|
27
|
Reasons for withdrawal
| Measure |
Rotigotine 2 mg/24 hr
2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 4 mg/24 hr
4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 6 mg/24 hr
6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 8 mg/24 hr
8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Placebo
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
12
|
15
|
12
|
5
|
17
|
|
Overall Study
Lack of Efficacy
|
3
|
0
|
2
|
2
|
7
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
1
|
2
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
2
|
0
|
0
|
|
Overall Study
Unsatisfactory Subject Compliance
|
1
|
2
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
4
|
2
|
2
|
|
Overall Study
Randomization error
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Dispensing error
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Subject Moved
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Sponsor Request
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Family Problem
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Site Closed
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Subject Withdrawal
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Trial to Assess Parkinson's Disease (PD) Symptom Control to Four Doses of Rotigotine in a Transdermal Patch
Baseline characteristics by cohort
| Measure |
Rotigotine 2 mg/24 hr
n=101 Participants
2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 4 mg/24 hr
n=107 Participants
4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 6 mg/24 hr
n=104 Participants
6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 8 mg/24 hr
n=94 Participants
8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Placebo
n=108 Participants
|
Total
n=514 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
244 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
55 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
270 Participants
n=10 Participants
|
|
Age, Continuous
|
65.4 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
64.6 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
64.6 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
63.2 years
STANDARD_DEVIATION 11.6 • n=4 Participants
|
64.8 years
STANDARD_DEVIATION 10.2 • n=21 Participants
|
64.5 years
STANDARD_DEVIATION 10.3 • n=10 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
155 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
74 Participants
n=21 Participants
|
359 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
66 participants
n=5 Participants
|
72 participants
n=7 Participants
|
68 participants
n=5 Participants
|
59 participants
n=4 Participants
|
69 participants
n=21 Participants
|
334 participants
n=10 Participants
|
|
Region of Enrollment
Mexico
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
5 participants
n=10 Participants
|
|
Region of Enrollment
Peru
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
3 participants
n=21 Participants
|
16 participants
n=10 Participants
|
|
Region of Enrollment
Chile
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
9 participants
n=10 Participants
|
|
Region of Enrollment
India
|
28 participants
n=5 Participants
|
29 participants
n=7 Participants
|
31 participants
n=5 Participants
|
29 participants
n=4 Participants
|
33 participants
n=21 Participants
|
150 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].Population: Of the 502 subjects in the Full Analysis Set (FAS), 502 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.
Time "Off" is defined as when the patient does not have the effect of anti-Parkinson's medication.
Outcome measures
| Measure |
Rotigotine 2 mg/24 hr
n=99 Participants
2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 4 mg/24 hr
n=103 Participants
4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 6 mg/24 hr
n=101 Participants
6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 8 mg/24 hr
n=94 Participants
8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Placebo
n=105 Participants
|
|---|---|---|---|---|---|
|
The Change in the Absolute Time Spent "Off" From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary
|
-1.948 Hours
Standard Deviation 2.587
|
-2.052 Hours
Standard Deviation 3.113
|
-2.138 Hours
Standard Deviation 2.721
|
-2.360 Hours
Standard Deviation 2.608
|
-1.499 Hours
Standard Deviation 3.062
|
SECONDARY outcome
Timeframe: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].Population: Of the 502 subjects in the Full Analysis Set (FAS), 502 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.
Time "Off" is defined as when the patient does not have the effect of anti-Parkinson's medication.
Outcome measures
| Measure |
Rotigotine 2 mg/24 hr
n=99 Participants
2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 4 mg/24 hr
n=103 Participants
4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 6 mg/24 hr
n=101 Participants
6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 8 mg/24 hr
n=94 Participants
8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Placebo
n=105 Participants
|
|---|---|---|---|---|---|
|
The Change in Relative Time Spent "Off" From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary
|
-12.058 Hours
Standard Deviation 16.517
|
-13.463 Hours
Standard Deviation 20.099
|
-13.410 Hours
Standard Deviation 17.202
|
-14.529 Hours
Standard Deviation 16.531
|
-9.250 Hours
Standard Deviation 18.942
|
SECONDARY outcome
Timeframe: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].Population: Of the 502 subjects in the Full Analysis Set (FAS), 502 are included in this analysis. The Last Observation Carried Forward method was utilized.
Time "On" is defined as when the patient has the effect of anti-Parkinson's medication.
Outcome measures
| Measure |
Rotigotine 2 mg/24 hr
n=99 Participants
2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 4 mg/24 hr
n=103 Participants
4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 6 mg/24 hr
n=101 Participants
6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 8 mg/24 hr
n=94 Participants
8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Placebo
n=105 Participants
|
|---|---|---|---|---|---|
|
The Change in the Absolute Time Spent "on" From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary
|
1.821 Hours
Standard Deviation 2.655
|
2.095 Hours
Standard Deviation 3.120
|
2.118 Hours
Standard Deviation 2.827
|
2.364 Hours
Standard Deviation 2.876
|
1.335 Hours
Standard Deviation 2.975
|
SECONDARY outcome
Timeframe: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].Population: Of the 502 subjects in the Full Analysis Set (FAS), 502 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.
Time "On" is defined as when the patient has the effect of anti-Parkinson's medication.
Outcome measures
| Measure |
Rotigotine 2 mg/24 hr
n=99 Participants
2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 4 mg/24 hr
n=103 Participants
4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 6 mg/24 hr
n=101 Participants
6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 8 mg/24 hr
n=94 Participants
8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Placebo
n=105 Participants
|
|---|---|---|---|---|---|
|
The Change in the Relative Time Spent "on" From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary
|
12.058 Hours
Standard Deviation 16.517
|
13.463 Hours
Standard Deviation 20.099
|
13.410 Hours
Standard Deviation 17.202
|
14.529 Hours
Standard Deviation 16.531
|
9.250 Hours
Standard Deviation 18.942
|
SECONDARY outcome
Timeframe: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].Population: Of the 502 subjects in the Full Analysis Set (FAS), 405 are included in this analysis.
Outcome measures
| Measure |
Rotigotine 2 mg/24 hr
n=80 Participants
2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 4 mg/24 hr
n=82 Participants
4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 6 mg/24 hr
n=82 Participants
6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 8 mg/24 hr
n=80 Participants
8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Placebo
n=81 Participants
|
|---|---|---|---|---|---|
|
The Change in the Status of the Subject After Wake-Up From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary
ON Without Troublesome Dyskinesias
|
23.688 Hours
Standard Deviation 41.607
|
24.593 Hours
Standard Deviation 43.006
|
20.935 Hours
Standard Deviation 42.132
|
21.083 Hours
Standard Deviation 45.642
|
19.712 Hours
Standard Deviation 41.857
|
|
The Change in the Status of the Subject After Wake-Up From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary
ON With Troublesome Dyskinesias
|
-0.667 Hours
Standard Deviation 18.874
|
-0.813 Hours
Standard Deviation 12.804
|
1.626 Hours
Standard Deviation 23.659
|
1.667 Hours
Standard Deviation 13.417
|
-0.206 Hours
Standard Deviation 8.934
|
|
The Change in the Status of the Subject After Wake-Up From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary
OFF
|
-23.021 Hours
Standard Deviation 40.667
|
-23.780 Hours
Standard Deviation 43.150
|
-22.561 Hours
Standard Deviation 40.519
|
-22.750 Hours
Standard Deviation 47.193
|
-19.506 Hours
Standard Deviation 43.298
|
SECONDARY outcome
Timeframe: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].Population: Of the 502 subjects in the Full Analysis Set (FAS), 497 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.
The Unified Parkinson's Disease Rating Scale (UPDRS) Part II is a scale for the assessment of function in Parkinson's disease. UPDRS Part II measures Activities of Daily Living. It consists of 13 questions, each ranging from 0 to 4. The sum score of the UPDRS Part II ranges from 0 to 52. A higher score indicates greater disability. A negative change score indicates improvement.
Outcome measures
| Measure |
Rotigotine 2 mg/24 hr
n=98 Participants
2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 4 mg/24 hr
n=101 Participants
4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 6 mg/24 hr
n=99 Participants
6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 8 mg/24 hr
n=94 Participants
8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Placebo
n=105 Participants
|
|---|---|---|---|---|---|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II From Baseline to the End of the Maintenance Period
|
-2.1 units on a scale
Standard Deviation 4.3
|
-2.2 units on a scale
Standard Deviation 3.9
|
-1.5 units on a scale
Standard Deviation 4.7
|
-2.1 units on a scale
Standard Deviation 4.6
|
-0.9 units on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].Population: Of the 502 subjects in the Full Analysis Set (FAS), 496 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.
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 score indicates improvement.
Outcome measures
| Measure |
Rotigotine 2 mg/24 hr
n=98 Participants
2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 4 mg/24 hr
n=100 Participants
4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 6 mg/24 hr
n=99 Participants
6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 8 mg/24 hr
n=94 Participants
8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Placebo
n=105 Participants
|
|---|---|---|---|---|---|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III From Baseline to the End of the Maintenance Period
|
-3.4 units on a scale
Standard Deviation 7.6
|
-4.5 units on a scale
Standard Deviation 7.5
|
-3.5 units on a scale
Standard Deviation 8.9
|
-5.9 units on a scale
Standard Deviation 7.6
|
-2.5 units on a scale
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].Population: Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.
Item = Duration (question #32) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - What proportion of the waking day are dyskinesias present? Has a possible score of 0 - 4 points (4 = maximum). A higher score indicates more severe symptoms. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
Outcome measures
| Measure |
Rotigotine 2 mg/24 hr
n=97 Participants
2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 4 mg/24 hr
n=101 Participants
4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 6 mg/24 hr
n=98 Participants
6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 8 mg/24 hr
n=94 Participants
8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Placebo
n=105 Participants
|
|---|---|---|---|---|---|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day Are Dyskinesias Present?
Worsening
|
15 participants
|
14 participants
|
13 participants
|
15 participants
|
12 participants
|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day Are Dyskinesias Present?
Equal
|
74 participants
|
72 participants
|
75 participants
|
69 participants
|
84 participants
|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day Are Dyskinesias Present?
Improvement
|
8 participants
|
15 participants
|
10 participants
|
10 participants
|
9 participants
|
SECONDARY outcome
Timeframe: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].Population: Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.
Item = Disability (question #33) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - How disabling are the dyskinesias? Has a possible score of 0 - 4 points (4 = maximum). A higher score indicates more severe symptoms. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
Outcome measures
| Measure |
Rotigotine 2 mg/24 hr
n=97 Participants
2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 4 mg/24 hr
n=101 Participants
4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 6 mg/24 hr
n=98 Participants
6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 8 mg/24 hr
n=94 Participants
8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Placebo
n=105 Participants
|
|---|---|---|---|---|---|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Disability: How Disabling Are the Dyskinesias?
Worsening
|
7 participants
|
6 participants
|
2 participants
|
6 participants
|
9 participants
|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Disability: How Disabling Are the Dyskinesias?
Equal
|
80 participants
|
89 participants
|
86 participants
|
78 participants
|
90 participants
|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Disability: How Disabling Are the Dyskinesias?
Improvement
|
10 participants
|
6 participants
|
10 participants
|
10 participants
|
6 participants
|
SECONDARY outcome
Timeframe: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].Population: Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.
Item = Painful Dyskinesia (question #34) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period - How painful are the dyskinesias? Has a possible score of 0 - 4 points (4 = maximum). A higher score indicates more severe symptoms. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
Outcome measures
| Measure |
Rotigotine 2 mg/24 hr
n=97 Participants
2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 4 mg/24 hr
n=101 Participants
4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 6 mg/24 hr
n=98 Participants
6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 8 mg/24 hr
n=94 Participants
8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Placebo
n=105 Participants
|
|---|---|---|---|---|---|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Painful Dyskinesias: How Painful Are the Dyskinesias?
Worsening
|
2 participants
|
3 participants
|
4 participants
|
2 participants
|
8 participants
|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Painful Dyskinesias: How Painful Are the Dyskinesias?
Equal
|
90 participants
|
94 participants
|
86 participants
|
87 participants
|
94 participants
|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Painful Dyskinesias: How Painful Are the Dyskinesias?
Improvement
|
5 participants
|
4 participants
|
8 participants
|
5 participants
|
3 participants
|
SECONDARY outcome
Timeframe: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].Population: Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.
Item = Presence of Early Morning Dystonia (question #35) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates early morning dystonia. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
Outcome measures
| Measure |
Rotigotine 2 mg/24 hr
n=97 Participants
2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 4 mg/24 hr
n=101 Participants
4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 6 mg/24 hr
n=98 Participants
6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 8 mg/24 hr
n=94 Participants
8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Placebo
n=105 Participants
|
|---|---|---|---|---|---|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Presence of Early Morning Dystonia
Worsening
|
5 participants
|
9 participants
|
7 participants
|
6 participants
|
14 participants
|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Presence of Early Morning Dystonia
Equal
|
81 participants
|
79 participants
|
78 participants
|
76 participants
|
82 participants
|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Presence of Early Morning Dystonia
Improvement
|
11 participants
|
13 participants
|
13 participants
|
12 participants
|
9 participants
|
SECONDARY outcome
Timeframe: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].Population: Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.
Item = Are "off" periods predictable (question #36) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates "off" periods are predictable. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
Outcome measures
| Measure |
Rotigotine 2 mg/24 hr
n=97 Participants
2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 4 mg/24 hr
n=101 Participants
4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 6 mg/24 hr
n=98 Participants
6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 8 mg/24 hr
n=94 Participants
8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Placebo
n=105 Participants
|
|---|---|---|---|---|---|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are "Off" Periods Predictable?
Worsening
|
6 participants
|
4 participants
|
12 participants
|
3 participants
|
11 participants
|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are "Off" Periods Predictable?
Equal
|
80 participants
|
82 participants
|
74 participants
|
80 participants
|
85 participants
|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are "Off" Periods Predictable?
Improvement
|
11 participants
|
15 participants
|
12 participants
|
11 participants
|
9 participants
|
SECONDARY outcome
Timeframe: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].Population: Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.
Item = Are "off" periods unpredictable (question #37) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates "off" periods are unpredictable. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
Outcome measures
| Measure |
Rotigotine 2 mg/24 hr
n=97 Participants
2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 4 mg/24 hr
n=101 Participants
4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 6 mg/24 hr
n=98 Participants
6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 8 mg/24 hr
n=94 Participants
8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Placebo
n=105 Participants
|
|---|---|---|---|---|---|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are "Off" Periods Unpredictable?
Worsening
|
15 participants
|
12 participants
|
8 participants
|
8 participants
|
12 participants
|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are "Off" Periods Unpredictable?
Equal
|
71 participants
|
78 participants
|
73 participants
|
75 participants
|
77 participants
|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Are "Off" Periods Unpredictable?
Improvement
|
11 participants
|
11 participants
|
17 participants
|
11 participants
|
16 participants
|
SECONDARY outcome
Timeframe: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].Population: Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.
Item = Do "off" periods come on suddenly, within a few seconds (question #38) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates "off" periods come on suddenly, within a few seconds. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
Outcome measures
| Measure |
Rotigotine 2 mg/24 hr
n=97 Participants
2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 4 mg/24 hr
n=101 Participants
4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 6 mg/24 hr
n=98 Participants
6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 8 mg/24 hr
n=94 Participants
8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Placebo
n=105 Participants
|
|---|---|---|---|---|---|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Do "Off" Periods Come on Suddenly?
Worsening
|
6 participants
|
7 participants
|
11 participants
|
9 participants
|
15 participants
|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Do "Off" Periods Come on Suddenly?
Equal
|
80 participants
|
83 participants
|
75 participants
|
67 participants
|
75 participants
|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Do "Off" Periods Come on Suddenly?
Improvement
|
11 participants
|
11 participants
|
12 participants
|
18 participants
|
15 participants
|
SECONDARY outcome
Timeframe: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].Population: Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.
Item = What proportion of the waking day is the subject "off", on average (question #39) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 - 4 points (4 = maximum). A higher score indicates the subject is "off" a larger portion of the waking day. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
Outcome measures
| Measure |
Rotigotine 2 mg/24 hr
n=97 Participants
2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 4 mg/24 hr
n=101 Participants
4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 6 mg/24 hr
n=98 Participants
6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 8 mg/24 hr
n=94 Participants
8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Placebo
n=105 Participants
|
|---|---|---|---|---|---|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day is the Subject "Off", on Average?
Worsening
|
8 participants
|
4 participants
|
8 participants
|
7 participants
|
11 participants
|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day is the Subject "Off", on Average?
Equal
|
52 participants
|
58 participants
|
58 participants
|
55 participants
|
61 participants
|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - What Proportion of the Waking Day is the Subject "Off", on Average?
Improvement
|
37 participants
|
39 participants
|
32 participants
|
32 participants
|
33 participants
|
SECONDARY outcome
Timeframe: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].Population: Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.
Item = Does the patient have anorexia, nausea, or vomiting (question #40) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has anorexia, nausea, or vomiting. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
Outcome measures
| Measure |
Rotigotine 2 mg/24 hr
n=97 Participants
2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 4 mg/24 hr
n=101 Participants
4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 6 mg/24 hr
n=98 Participants
6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 8 mg/24 hr
n=94 Participants
8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Placebo
n=105 Participants
|
|---|---|---|---|---|---|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Anorexia, Nausea, or Vomiting?
Worsening
|
4 participants
|
2 participants
|
3 participants
|
5 participants
|
3 participants
|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Anorexia, Nausea, or Vomiting?
Equal
|
88 participants
|
96 participants
|
90 participants
|
85 participants
|
96 participants
|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Anorexia, Nausea, or Vomiting?
Improvement
|
5 participants
|
3 participants
|
5 participants
|
4 participants
|
6 participants
|
SECONDARY outcome
Timeframe: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].Population: Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.
Item = Does the patient have any sleep disturbances such as insomnia or hypersomnolence (question #41) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has sleep disturbances such as insomnia or hypersomnolence. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
Outcome measures
| Measure |
Rotigotine 2 mg/24 hr
n=97 Participants
2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 4 mg/24 hr
n=101 Participants
4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 6 mg/24 hr
n=98 Participants
6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 8 mg/24 hr
n=94 Participants
8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Placebo
n=105 Participants
|
|---|---|---|---|---|---|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Any Sleep Disturbances Such as Insomnia or Hypersomnolence?
Worsening
|
13 participants
|
14 participants
|
7 participants
|
4 participants
|
12 participants
|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Any Sleep Disturbances Such as Insomnia or Hypersomnolence?
Equal
|
70 participants
|
72 participants
|
75 participants
|
77 participants
|
78 participants
|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Any Sleep Disturbances Such as Insomnia or Hypersomnolence?
Improvement
|
14 participants
|
15 participants
|
16 participants
|
13 participants
|
15 participants
|
SECONDARY outcome
Timeframe: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].Population: Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method was utilized.
Item = Does the patient have symptomatic orthostasis (question #42) in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV from Baseline to the end of the Maintenance Period has a possible score of 0 (no) or 1 (yes). A score of 1 indicates subject has symptomatic orthostasis. Results show the number of subjects per dose group and their change over time either improving (decrease in score), worsening (increase in score), or remaining the same.
Outcome measures
| Measure |
Rotigotine 2 mg/24 hr
n=97 Participants
2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 4 mg/24 hr
n=101 Participants
4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 6 mg/24 hr
n=98 Participants
6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 8 mg/24 hr
n=94 Participants
8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Placebo
n=105 Participants
|
|---|---|---|---|---|---|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Symptomatic Orthostasis?
Worsening
|
0 participants
|
6 participants
|
2 participants
|
4 participants
|
8 participants
|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Symptomatic Orthostasis?
Equal
|
91 participants
|
93 participants
|
92 participants
|
88 participants
|
91 participants
|
|
The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part IV From Baseline to the End of the Maintenance Period - Does the Patient Have Symptomatic Orthostasis?
Improvement
|
6 participants
|
2 participants
|
4 participants
|
2 participants
|
6 participants
|
SECONDARY outcome
Timeframe: From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].Population: Of the 502 subjects in the Full Analysis Set (FAS), 405 are included in this analysis. The Observed Cases (OC) method was utilized.
Time "Off" is defined as when the patient does not have the effect of anti-Parkinson's medication.
Outcome measures
| Measure |
Rotigotine 2 mg/24 hr
n=80 Participants
2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 4 mg/24 hr
n=82 Participants
4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 6 mg/24 hr
n=82 Participants
6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 8 mg/24 hr
n=80 Participants
8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Placebo
n=81 Participants
|
|---|---|---|---|---|---|
|
The Change in Number of "Off" Periods From Baseline to the End of the Maintenance Period as Recorded by the Subject in a Daily Diary
|
-1.144 Hours
Standard Deviation 1.687
|
-1.294 Hours
Standard Deviation 1.971
|
-1.323 Hours
Standard Deviation 1.348
|
-1.304 Hours
Standard Deviation 1.442
|
-1.006 Hours
Standard Deviation 1.474
|
Adverse Events
Rotigotine 2 mg/24 hr
Serious events: 4 serious events
Other events: 54 other events
Deaths: 0 deaths
Rotigotine 4 mg/24 hr
Serious events: 3 serious events
Other events: 54 other events
Deaths: 0 deaths
Rotigotine 6 mg/24 hr
Serious events: 2 serious events
Other events: 49 other events
Deaths: 0 deaths
Rotigotine 8 mg/24 hr
Serious events: 0 serious events
Other events: 52 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rotigotine 2 mg/24 hr
n=101 participants at risk
2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 4 mg/24 hr
n=107 participants at risk
4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 6 mg/24 hr
n=104 participants at risk
6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 8 mg/24 hr
n=94 participants at risk
8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Placebo
n=108 participants at risk
|
|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/101 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/107 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/104 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/94 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Cardiac disorders
Bundle branch block left
|
0.99%
1/101 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/107 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/104 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/94 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/108 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.99%
1/101 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/107 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/104 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/94 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/108 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Infections and infestations
Orchitis
|
0.99%
1/101 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/107 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/104 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/94 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/108 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/101 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.93%
1/107 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.96%
1/104 • Number of events 2 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/94 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/108 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/101 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.93%
1/107 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/104 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/94 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/108 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/101 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.93%
1/107 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/104 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/94 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/108 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.00%
0/101 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/107 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.96%
1/104 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/94 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/108 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/101 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/107 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.96%
1/104 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/94 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/108 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/101 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/107 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.96%
1/104 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/94 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/108 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/101 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.93%
1/107 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/104 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/94 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/108 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/101 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/107 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/104 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/94 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/101 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/107 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.96%
1/104 • Number of events 2 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/94 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/108 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/101 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/107 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.96%
1/104 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/94 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/108 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Psychiatric disorders
Sleep attacks
|
0.00%
0/101 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/107 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/104 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/94 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Psychiatric disorders
Mental status changes
|
0.99%
1/101 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/107 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/104 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/94 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/108 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.99%
1/101 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/107 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/104 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/94 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/108 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/101 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.93%
1/107 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/104 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/94 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/108 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
General disorders
Gastrooesophageal reflux disease
|
0.00%
0/101 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/107 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/104 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/94 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.99%
1/101 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/107 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/104 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/94 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/108 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Pubic rami fracture
|
0.99%
1/101 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/107 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/104 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/94 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/108 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/101 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/107 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/104 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/94 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
Other adverse events
| Measure |
Rotigotine 2 mg/24 hr
n=101 participants at risk
2 mg/24 hr (one 10 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 4 mg/24 hr
n=107 participants at risk
4 mg/24 hr (one 20 cm\^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 6 mg/24 hr
n=104 participants at risk
6 mg/24 hr (one 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Rotigotine 8 mg/24 hr
n=94 participants at risk
8 mg/24 hr (two 10 cm\^2 \& one 20 cm\^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
|
Placebo
n=108 participants at risk
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
12.9%
13/101 • Number of events 17 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
10.3%
11/107 • Number of events 12 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
14.4%
15/104 • Number of events 19 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
11.7%
11/94 • Number of events 11 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
7.4%
8/108 • Number of events 10 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
0.99%
1/101 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
3.7%
4/107 • Number of events 4 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
7.7%
8/104 • Number of events 8 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
4.3%
4/94 • Number of events 5 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
7.4%
8/108 • Number of events 8 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dry mouth
|
3.0%
3/101 • Number of events 3 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
6.5%
7/107 • Number of events 8 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
6.7%
7/104 • Number of events 7 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
5.3%
5/94 • Number of events 5 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/108 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
6.9%
7/101 • Number of events 7 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
4.7%
5/107 • Number of events 5 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
1.9%
2/104 • Number of events 2 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
4.3%
4/94 • Number of events 4 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
5.6%
6/108 • Number of events 7 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
General disorders
Application site pruritus
|
4.0%
4/101 • Number of events 4 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
5.6%
6/107 • Number of events 6 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
7.7%
8/104 • Number of events 8 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
7.4%
7/94 • Number of events 8 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
1.9%
2/108 • Number of events 2 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
General disorders
Application site erythema
|
4.0%
4/101 • Number of events 4 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
4.7%
5/107 • Number of events 5 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
6.7%
7/104 • Number of events 8 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
5.3%
5/94 • Number of events 5 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
1.9%
2/108 • Number of events 2 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
6.9%
7/101 • Number of events 8 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
1.9%
2/107 • Number of events 2 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
1.9%
2/104 • Number of events 2 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
1.1%
1/94 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
3.7%
4/108 • Number of events 4 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.0%
4/101 • Number of events 4 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
5.6%
6/107 • Number of events 6 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/104 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
2.1%
2/94 • Number of events 2 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
3.7%
4/108 • Number of events 5 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
6.9%
7/101 • Number of events 9 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
5.6%
6/107 • Number of events 7 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
3.8%
4/104 • Number of events 12 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
6.4%
6/94 • Number of events 6 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
6.5%
7/108 • Number of events 11 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
2/101 • Number of events 2 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.93%
1/107 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
4.8%
5/104 • Number of events 5 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
5.3%
5/94 • Number of events 6 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
4.6%
5/108 • Number of events 5 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.99%
1/101 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
2.8%
3/107 • Number of events 4 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
2.9%
3/104 • Number of events 3 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
5.3%
5/94 • Number of events 8 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
2.8%
3/108 • Number of events 3 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
9.9%
10/101 • Number of events 11 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
7.5%
8/107 • Number of events 8 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
5.8%
6/104 • Number of events 7 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
8.5%
8/94 • Number of events 10 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
11.1%
12/108 • Number of events 18 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
7.9%
8/101 • Number of events 8 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
10.3%
11/107 • Number of events 12 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
6.7%
7/104 • Number of events 9 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
6.4%
6/94 • Number of events 6 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
8.3%
9/108 • Number of events 9 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Nervous system disorders
Somnolence
|
6.9%
7/101 • Number of events 8 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
5.6%
6/107 • Number of events 6 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
7.7%
8/104 • Number of events 11 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
4.3%
4/94 • Number of events 4 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
8.3%
9/108 • Number of events 10 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Nervous system disorders
Dyskinesia
|
5.0%
5/101 • Number of events 6 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
3.7%
4/107 • Number of events 4 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
10.6%
11/104 • Number of events 11 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
14.9%
14/94 • Number of events 18 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
2.8%
3/108 • Number of events 6 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Nervous system disorders
Tremor
|
3.0%
3/101 • Number of events 3 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
2.8%
3/107 • Number of events 3 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
2.9%
3/104 • Number of events 3 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
5.3%
5/94 • Number of events 5 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
2.8%
3/108 • Number of events 7 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
5.9%
6/101 • Number of events 6 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
7.5%
8/107 • Number of events 9 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
5.8%
6/104 • Number of events 6 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
6.4%
6/94 • Number of events 6 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
6.5%
7/108 • Number of events 8 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Psychiatric disorders
Confusional state
|
5.0%
5/101 • Number of events 5 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
1.9%
2/107 • Number of events 2 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
5.8%
6/104 • Number of events 6 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
1.1%
1/94 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
1.9%
2/108 • Number of events 2 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
|
Vascular disorders
Orthostatic hypotension
|
3.0%
3/101 • Number of events 3 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.93%
1/107 • Number of events 1 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
0.00%
0/104 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
2.1%
2/94 • Number of events 2 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
6.5%
7/108 • Number of events 9 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
|
Additional Information
UCB (Study Director)
UCB Clinical Trial Call Center
Phone: +1 887 822 9493
Results disclosure agreements
- Principal investigator is a sponsor employee UCB has \> 60 but \<= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER