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Trial record 1 of 1 for:    NCT00522379
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Trial to Assess Parkinson's Disease (PD) Symptom Control to Four Doses of Rotigotine in a Transdermal Patch

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00522379
Recruitment Status : Completed
First Posted : August 29, 2007
Results First Posted : December 10, 2012
Last Update Posted : October 27, 2014
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Parkinson's Disease
Interventions Drug: Rotigotine
Other: Placebo
Enrollment 514
Recruitment Details

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.

Pre-assignment Details

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.

Arm/Group Title Rotigotine 2 mg/24 hr Rotigotine 4 mg/24 hr Rotigotine 6 mg/24 hr Rotigotine 8 mg/24 hr Placebo
Hide Arm/Group Description 2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks 4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks 6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks 8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks [Not Specified]
Period Title: Overall Study
Started 101 107 104 94 108
Completed 79 84 82 80 81
Not Completed 22 23 22 14 27
Reason Not Completed
Adverse Event             12             15             12             5             17
Lack of Efficacy             3             0             2             2             7
Withdrawal by Subject             2             3             1             2             0
Protocol Violation             1             1             2             0             0
Unsatisfactory Subject Compliance             1             2             0             0             0
Lost to Follow-up             1             0             4             2             2
Randomization error             0             0             0             0             1
Dispensing error             1             0             0             1             0
Subject Moved             1             1             0             0             0
Sponsor Request             0             1             0             0             0
Family Problem             0             0             1             0             0
Site Closed             0             0             0             1             0
Subject Withdrawal             0             0             0             1             0
Arm/Group Title Rotigotine 2 mg/24 hr Rotigotine 4 mg/24 hr Rotigotine 6 mg/24 hr Rotigotine 8 mg/24 hr Placebo Total
Hide Arm/Group Description 2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks 4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks 6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks 8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 101 107 104 94 108 514
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 107 participants 104 participants 94 participants 108 participants 514 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
46
  45.5%
54
  50.5%
47
  45.2%
49
  52.1%
48
  44.4%
244
  47.5%
>=65 years
55
  54.5%
53
  49.5%
57
  54.8%
45
  47.9%
60
  55.6%
270
  52.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants 107 participants 104 participants 94 participants 108 participants 514 participants
65.4  (10.5) 64.6  (9.0) 64.6  (10.4) 63.2  (11.6) 64.8  (10.2) 64.5  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 107 participants 104 participants 94 participants 108 participants 514 participants
Female
24
  23.8%
28
  26.2%
31
  29.8%
38
  40.4%
34
  31.5%
155
  30.2%
Male
77
  76.2%
79
  73.8%
73
  70.2%
56
  59.6%
74
  68.5%
359
  69.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants 107 participants 104 participants 94 participants 108 participants 514 participants
United States 66 72 68 59 69 334
Mexico 1 1 2 0 1 5
Peru 4 3 2 4 3 16
Chile 2 2 1 2 2 9
India 28 29 31 29 33 150
1.Primary Outcome
Title 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
Hide Description Time "Off" is defined as when the patient does not have the effect of anti-Parkinson's medication.
Time Frame From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rotigotine 2 mg/24 hr Rotigotine 4 mg/24 hr Rotigotine 6 mg/24 hr Rotigotine 8 mg/24 hr Placebo
Hide Arm/Group Description:
2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
[Not Specified]
Overall Number of Participants Analyzed 99 103 101 94 105
Mean (Standard Deviation)
Unit of Measure: Hours
-1.948  (2.587) -2.052  (3.113) -2.138  (2.721) -2.360  (2.608) -1.499  (3.062)
2.Secondary Outcome
Title 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
Hide Description Time "Off" is defined as when the patient does not have the effect of anti-Parkinson's medication.
Time Frame From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rotigotine 2 mg/24 hr Rotigotine 4 mg/24 hr Rotigotine 6 mg/24 hr Rotigotine 8 mg/24 hr Placebo
Hide Arm/Group Description:
2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
[Not Specified]
Overall Number of Participants Analyzed 99 103 101 94 105
Mean (Standard Deviation)
Unit of Measure: Hours
-12.058  (16.517) -13.463  (20.099) -13.410  (17.202) -14.529  (16.531) -9.250  (18.942)
3.Secondary Outcome
Title 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
Hide Description Time "On" is defined as when the patient has the effect of anti-Parkinson's medication.
Time Frame From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 502 subjects in the Full Analysis Set (FAS), 502 are included in this analysis. The Last Observation Carried Forward method was utilized.
Arm/Group Title Rotigotine 2 mg/24 hr Rotigotine 4 mg/24 hr Rotigotine 6 mg/24 hr Rotigotine 8 mg/24 hr Placebo
Hide Arm/Group Description:
2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
[Not Specified]
Overall Number of Participants Analyzed 99 103 101 94 105
Mean (Standard Deviation)
Unit of Measure: Hours
1.821  (2.655) 2.095  (3.120) 2.118  (2.827) 2.364  (2.876) 1.335  (2.975)
4.Secondary Outcome
Title 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
Hide Description Time "On" is defined as when the patient has the effect of anti-Parkinson's medication.
Time Frame From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rotigotine 2 mg/24 hr Rotigotine 4 mg/24 hr Rotigotine 6 mg/24 hr Rotigotine 8 mg/24 hr Placebo
Hide Arm/Group Description:
2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
[Not Specified]
Overall Number of Participants Analyzed 99 103 101 94 105
Mean (Standard Deviation)
Unit of Measure: Hours
12.058  (16.517) 13.463  (20.099) 13.410  (17.202) 14.529  (16.531) 9.250  (18.942)
5.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 502 subjects in the Full Analysis Set (FAS), 405 are included in this analysis.
Arm/Group Title Rotigotine 2 mg/24 hr Rotigotine 4 mg/24 hr Rotigotine 6 mg/24 hr Rotigotine 8 mg/24 hr Placebo
Hide Arm/Group Description:
2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
[Not Specified]
Overall Number of Participants Analyzed 80 82 82 80 81
Mean (Standard Deviation)
Unit of Measure: Hours
ON Without Troublesome Dyskinesias 23.688  (41.607) 24.593  (43.006) 20.935  (42.132) 21.083  (45.642) 19.712  (41.857)
ON With Troublesome Dyskinesias -0.667  (18.874) -0.813  (12.804) 1.626  (23.659) 1.667  (13.417) -0.206  (8.934)
OFF -23.021  (40.667) -23.780  (43.150) -22.561  (40.519) -22.750  (47.193) -19.506  (43.298)
6.Secondary Outcome
Title The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II From Baseline to the End of the Maintenance Period
Hide Description 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.
Time Frame From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 502 subjects in the Full Analysis Set (FAS), 497 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.
Arm/Group Title Rotigotine 2 mg/24 hr Rotigotine 4 mg/24 hr Rotigotine 6 mg/24 hr Rotigotine 8 mg/24 hr Placebo
Hide Arm/Group Description:
2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
[Not Specified]
Overall Number of Participants Analyzed 98 101 99 94 105
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.1  (4.3) -2.2  (3.9) -1.5  (4.7) -2.1  (4.6) -0.9  (3.7)
7.Secondary Outcome
Title The Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III From Baseline to the End of the Maintenance Period
Hide Description 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.
Time Frame From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 502 subjects in the Full Analysis Set (FAS), 496 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.
Arm/Group Title Rotigotine 2 mg/24 hr Rotigotine 4 mg/24 hr Rotigotine 6 mg/24 hr Rotigotine 8 mg/24 hr Placebo
Hide Arm/Group Description:
2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
[Not Specified]
Overall Number of Participants Analyzed 98 100 99 94 105
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.4  (7.6) -4.5  (7.5) -3.5  (8.9) -5.9  (7.6) -2.5  (8.2)
8.Secondary Outcome
Title 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?
Hide Description

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.

Time Frame From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.
Arm/Group Title Rotigotine 2 mg/24 hr Rotigotine 4 mg/24 hr Rotigotine 6 mg/24 hr Rotigotine 8 mg/24 hr Placebo
Hide Arm/Group Description:
2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
[Not Specified]
Overall Number of Participants Analyzed 97 101 98 94 105
Measure Type: Number
Unit of Measure: participants
Worsening 15 14 13 15 12
Equal 74 72 75 69 84
Improvement 8 15 10 10 9
9.Secondary Outcome
Title 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?
Hide Description

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.

Time Frame From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.
Arm/Group Title Rotigotine 2 mg/24 hr Rotigotine 4 mg/24 hr Rotigotine 6 mg/24 hr Rotigotine 8 mg/24 hr Placebo
Hide Arm/Group Description:
2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
[Not Specified]
Overall Number of Participants Analyzed 97 101 98 94 105
Measure Type: Number
Unit of Measure: participants
Worsening 7 6 2 6 9
Equal 80 89 86 78 90
Improvement 10 6 10 10 6
10.Secondary Outcome
Title 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?
Hide Description

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.

Time Frame From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 502 subjects in the Full Analysis Set (FAS), 495 are included in this analysis. The Last Observation Carried Forward (LOCF) method utilized.
Arm/Group Title Rotigotine 2 mg/24 hr Rotigotine 4 mg/24 hr Rotigotine 6 mg/24 hr Rotigotine 8 mg/24 hr Placebo
Hide Arm/Group Description:
2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
[Not Specified]
Overall Number of Participants Analyzed 97 101 98 94 105
Measure Type: Number
Unit of Measure: participants
Worsening 2 3 4 2 8
Equal 90 94 86 87 94
Improvement 5 4 8 5 3
11.Secondary Outcome
Title 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
Hide Description

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.

Time Frame From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rotigotine 2 mg/24 hr Rotigotine 4 mg/24 hr Rotigotine 6 mg/24 hr Rotigotine 8 mg/24 hr Placebo
Hide Arm/Group Description:
2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
[Not Specified]
Overall Number of Participants Analyzed 97 101 98 94 105
Measure Type: Number
Unit of Measure: participants
Worsening 5 9 7 6 14
Equal 81 79 78 76 82
Improvement 11 13 13 12 9
12.Secondary Outcome
Title 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?
Hide Description

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.

Time Frame From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rotigotine 2 mg/24 hr Rotigotine 4 mg/24 hr Rotigotine 6 mg/24 hr Rotigotine 8 mg/24 hr Placebo
Hide Arm/Group Description:
2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
[Not Specified]
Overall Number of Participants Analyzed 97 101 98 94 105
Measure Type: Number
Unit of Measure: participants
Worsening 6 4 12 3 11
Equal 80 82 74 80 85
Improvement 11 15 12 11 9
13.Secondary Outcome
Title 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?
Hide Description

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.

Time Frame From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rotigotine 2 mg/24 hr Rotigotine 4 mg/24 hr Rotigotine 6 mg/24 hr Rotigotine 8 mg/24 hr Placebo
Hide Arm/Group Description:
2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
[Not Specified]
Overall Number of Participants Analyzed 97 101 98 94 105
Measure Type: Number
Unit of Measure: participants
Worsening 15 12 8 8 12
Equal 71 78 73 75 77
Improvement 11 11 17 11 16
14.Secondary Outcome
Title 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?
Hide Description

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.

Time Frame From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rotigotine 2 mg/24 hr Rotigotine 4 mg/24 hr Rotigotine 6 mg/24 hr Rotigotine 8 mg/24 hr Placebo
Hide Arm/Group Description:
2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
[Not Specified]
Overall Number of Participants Analyzed 97 101 98 94 105
Measure Type: Number
Unit of Measure: participants
Worsening 6 7 11 9 15
Equal 80 83 75 67 75
Improvement 11 11 12 18 15
15.Secondary Outcome
Title 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?
Hide Description

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.

Time Frame From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rotigotine 2 mg/24 hr Rotigotine 4 mg/24 hr Rotigotine 6 mg/24 hr Rotigotine 8 mg/24 hr Placebo
Hide Arm/Group Description:
2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
[Not Specified]
Overall Number of Participants Analyzed 97 101 98 94 105
Measure Type: Number
Unit of Measure: participants
Worsening 8 4 8 7 11
Equal 52 58 58 55 61
Improvement 37 39 32 32 33
16.Secondary Outcome
Title 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?
Hide Description

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.

Time Frame From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rotigotine 2 mg/24 hr Rotigotine 4 mg/24 hr Rotigotine 6 mg/24 hr Rotigotine 8 mg/24 hr Placebo
Hide Arm/Group Description:
2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
[Not Specified]
Overall Number of Participants Analyzed 97 101 98 94 105
Measure Type: Number
Unit of Measure: participants
Worsening 4 2 3 5 3
Equal 88 96 90 85 96
Improvement 5 3 5 4 6
17.Secondary Outcome
Title 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?
Hide Description

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.

Time Frame From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rotigotine 2 mg/24 hr Rotigotine 4 mg/24 hr Rotigotine 6 mg/24 hr Rotigotine 8 mg/24 hr Placebo
Hide Arm/Group Description:
2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
[Not Specified]
Overall Number of Participants Analyzed 97 101 98 94 105
Measure Type: Number
Unit of Measure: participants
Worsening 13 14 7 4 12
Equal 70 72 75 77 78
Improvement 14 15 16 13 15
18.Secondary Outcome
Title 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?
Hide Description

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.

Time Frame From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Rotigotine 2 mg/24 hr Rotigotine 4 mg/24 hr Rotigotine 6 mg/24 hr Rotigotine 8 mg/24 hr Placebo
Hide Arm/Group Description:
2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
[Not Specified]
Overall Number of Participants Analyzed 97 101 98 94 105
Measure Type: Number
Unit of Measure: participants
Worsening 0 6 2 4 8
Equal 91 93 92 88 91
Improvement 6 2 4 2 6
19.Secondary Outcome
Title 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
Hide Description Time "Off" is defined as when the patient does not have the effect of anti-Parkinson's medication.
Time Frame From Baseline to the End of the Maintenance Period [16 Weeks Treatment Period (4 weeks Titration Period and 12 weeks Maintenance Period)].
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 502 subjects in the Full Analysis Set (FAS), 405 are included in this analysis. The Observed Cases (OC) method was utilized.
Arm/Group Title Rotigotine 2 mg/24 hr Rotigotine 4 mg/24 hr Rotigotine 6 mg/24 hr Rotigotine 8 mg/24 hr Placebo
Hide Arm/Group Description:
2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
[Not Specified]
Overall Number of Participants Analyzed 80 82 82 80 81
Mean (Standard Deviation)
Unit of Measure: Hours
-1.144  (1.687) -1.294  (1.971) -1.323  (1.348) -1.304  (1.442) -1.006  (1.474)
Time Frame Adverse Events (AEs) were collected during the course of the trial, which was approximately 33 weeks per subject.
Adverse Event Reporting Description 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.
 
Arm/Group Title Rotigotine 2 mg/24 hr Rotigotine 4 mg/24 hr Rotigotine 6 mg/24 hr Rotigotine 8 mg/24 hr Placebo
Hide Arm/Group Description 2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks 4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks 6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks 8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks [Not Specified]
All-Cause Mortality
Rotigotine 2 mg/24 hr Rotigotine 4 mg/24 hr Rotigotine 6 mg/24 hr Rotigotine 8 mg/24 hr Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Rotigotine 2 mg/24 hr Rotigotine 4 mg/24 hr Rotigotine 6 mg/24 hr Rotigotine 8 mg/24 hr Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/101 (3.96%)      3/107 (2.80%)      2/104 (1.92%)      0/94 (0.00%)      5/108 (4.63%)    
Cardiac disorders           
Myocardial infarction * 1  0/101 (0.00%)  0 0/107 (0.00%)  0 0/104 (0.00%)  0 0/94 (0.00%)  0 1/108 (0.93%)  1
Bundle branch block left * 1  1/101 (0.99%)  1 0/107 (0.00%)  0 0/104 (0.00%)  0 0/94 (0.00%)  0 0/108 (0.00%)  0
Gastrointestinal disorders           
Gastrointestinal haemorrhage * 1  1/101 (0.99%)  1 0/107 (0.00%)  0 0/104 (0.00%)  0 0/94 (0.00%)  0 0/108 (0.00%)  0
Mallory-Weiss syndrome * 1  0/101 (0.00%)  0 1/107 (0.93%)  1 0/104 (0.00%)  0 0/94 (0.00%)  0 0/108 (0.00%)  0
General disorders           
Gastrooesophageal reflux disease * 1  0/101 (0.00%)  0 0/107 (0.00%)  0 0/104 (0.00%)  0 0/94 (0.00%)  0 1/108 (0.93%)  1
Infections and infestations           
Orchitis * 1  1/101 (0.99%)  1 0/107 (0.00%)  0 0/104 (0.00%)  0 0/94 (0.00%)  0 0/108 (0.00%)  0
Injury, poisoning and procedural complications           
Fall * 1  0/101 (0.00%)  0 1/107 (0.93%)  1 1/104 (0.96%)  2 0/94 (0.00%)  0 0/108 (0.00%)  0
Joint injury * 1  0/101 (0.00%)  0 1/107 (0.93%)  1 0/104 (0.00%)  0 0/94 (0.00%)  0 0/108 (0.00%)  0
Lumbar vertebral fracture * 1  0/101 (0.00%)  0 1/107 (0.93%)  1 0/104 (0.00%)  0 0/94 (0.00%)  0 0/108 (0.00%)  0
Brain herniation * 1  0/101 (0.00%)  0 0/107 (0.00%)  0 1/104 (0.96%)  1 0/94 (0.00%)  0 0/108 (0.00%)  0
Head injury * 1  0/101 (0.00%)  0 0/107 (0.00%)  0 1/104 (0.96%)  1 0/94 (0.00%)  0 0/108 (0.00%)  0
Skull fracture * 1  0/101 (0.00%)  0 0/107 (0.00%)  0 1/104 (0.96%)  1 0/94 (0.00%)  0 0/108 (0.00%)  0
Acetabulum fracture * 1  1/101 (0.99%)  1 0/107 (0.00%)  0 0/104 (0.00%)  0 0/94 (0.00%)  0 0/108 (0.00%)  0
Pubic rami fracture * 1  1/101 (0.99%)  1 0/107 (0.00%)  0 0/104 (0.00%)  0 0/94 (0.00%)  0 0/108 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Rotator cuff syndrome * 1  0/101 (0.00%)  0 1/107 (0.93%)  1 0/104 (0.00%)  0 0/94 (0.00%)  0 0/108 (0.00%)  0
Nervous system disorders           
Cerebral haemorrhage * 1  0/101 (0.00%)  0 0/107 (0.00%)  0 0/104 (0.00%)  0 0/94 (0.00%)  0 1/108 (0.93%)  1
Haemorrhage intracranial * 1  0/101 (0.00%)  0 0/107 (0.00%)  0 1/104 (0.96%)  2 0/94 (0.00%)  0 0/108 (0.00%)  0
Transient ischaemic attack * 1  0/101 (0.00%)  0 0/107 (0.00%)  0 1/104 (0.96%)  1 0/94 (0.00%)  0 0/108 (0.00%)  0
Cerebrovascular accident * 1  0/101 (0.00%)  0 0/107 (0.00%)  0 0/104 (0.00%)  0 0/94 (0.00%)  0 1/108 (0.93%)  1
Psychiatric disorders           
Sleep attacks * 1  0/101 (0.00%)  0 0/107 (0.00%)  0 0/104 (0.00%)  0 0/94 (0.00%)  0 1/108 (0.93%)  1
Mental status changes * 1  1/101 (0.99%)  1 0/107 (0.00%)  0 0/104 (0.00%)  0 0/94 (0.00%)  0 0/108 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Pneumonia aspiration * 1  1/101 (0.99%)  1 0/107 (0.00%)  0 0/104 (0.00%)  0 0/94 (0.00%)  0 0/108 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rotigotine 2 mg/24 hr Rotigotine 4 mg/24 hr Rotigotine 6 mg/24 hr Rotigotine 8 mg/24 hr Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   54/101 (53.47%)      54/107 (50.47%)      49/104 (47.12%)      52/94 (55.32%)      54/108 (50.00%)    
Gastrointestinal disorders           
Nausea * 1  13/101 (12.87%)  17 11/107 (10.28%)  12 15/104 (14.42%)  19 11/94 (11.70%)  11 8/108 (7.41%)  10
Constipation * 1  1/101 (0.99%)  1 4/107 (3.74%)  4 8/104 (7.69%)  8 4/94 (4.26%)  5 8/108 (7.41%)  8
Dry mouth * 1  3/101 (2.97%)  3 7/107 (6.54%)  8 7/104 (6.73%)  7 5/94 (5.32%)  5 0/108 (0.00%)  0
General disorders           
Fatigue * 1  7/101 (6.93%)  7 5/107 (4.67%)  5 2/104 (1.92%)  2 4/94 (4.26%)  4 6/108 (5.56%)  7
Application site pruritus * 1  4/101 (3.96%)  4 6/107 (5.61%)  6 8/104 (7.69%)  8 7/94 (7.45%)  8 2/108 (1.85%)  2
Application site erythema * 1  4/101 (3.96%)  4 5/107 (4.67%)  5 7/104 (6.73%)  8 5/94 (5.32%)  5 2/108 (1.85%)  2
Infections and infestations           
Urinary tract infection * 1  7/101 (6.93%)  8 2/107 (1.87%)  2 2/104 (1.92%)  2 1/94 (1.06%)  1 4/108 (3.70%)  4
Upper respiratory tract infection * 1  4/101 (3.96%)  4 6/107 (5.61%)  6 0/104 (0.00%)  0 2/94 (2.13%)  2 4/108 (3.70%)  5
Injury, poisoning and procedural complications           
Fall * 1  7/101 (6.93%)  9 6/107 (5.61%)  7 4/104 (3.85%)  12 6/94 (6.38%)  6 7/108 (6.48%)  11
Musculoskeletal and connective tissue disorders           
Back pain * 1  2/101 (1.98%)  2 1/107 (0.93%)  1 5/104 (4.81%)  5 5/94 (5.32%)  6 5/108 (4.63%)  5
Arthralgia * 1  1/101 (0.99%)  1 3/107 (2.80%)  4 3/104 (2.88%)  3 5/94 (5.32%)  8 3/108 (2.78%)  3
Nervous system disorders           
Headache * 1  10/101 (9.90%)  11 8/107 (7.48%)  8 6/104 (5.77%)  7 8/94 (8.51%)  10 12/108 (11.11%)  18
Dizziness * 1  8/101 (7.92%)  8 11/107 (10.28%)  12 7/104 (6.73%)  9 6/94 (6.38%)  6 9/108 (8.33%)  9
Somnolence * 1  7/101 (6.93%)  8 6/107 (5.61%)  6 8/104 (7.69%)  11 4/94 (4.26%)  4 9/108 (8.33%)  10
Dyskinesia * 1  5/101 (4.95%)  6 4/107 (3.74%)  4 11/104 (10.58%)  11 14/94 (14.89%)  18 3/108 (2.78%)  6
Tremor * 1  3/101 (2.97%)  3 3/107 (2.80%)  3 3/104 (2.88%)  3 5/94 (5.32%)  5 3/108 (2.78%)  7
Psychiatric disorders           
Insomnia * 1  6/101 (5.94%)  6 8/107 (7.48%)  9 6/104 (5.77%)  6 6/94 (6.38%)  6 7/108 (6.48%)  8
Confusional state * 1  5/101 (4.95%)  5 2/107 (1.87%)  2 6/104 (5.77%)  6 1/94 (1.06%)  1 2/108 (1.85%)  2
Vascular disorders           
Orthostatic hypotension * 1  3/101 (2.97%)  3 1/107 (0.93%)  1 0/104 (0.00%)  0 2/94 (2.13%)  2 7/108 (6.48%)  9
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB (Study Director)
Organization: UCB Clinical Trial Call Center
Phone: +1 887 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00522379    
Other Study ID Numbers: SP0921
First Submitted: August 28, 2007
First Posted: August 29, 2007
Results First Submitted: July 3, 2012
Results First Posted: December 10, 2012
Last Update Posted: October 27, 2014