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Trial record 1 of 1 for:    NCT00593606
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Safety and Tolerability Trial of Switching From Ropinirole to Rotigotine

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ClinicalTrials.gov Identifier: NCT00593606
Recruitment Status : Completed
First Posted : January 15, 2008
Results First Posted : May 27, 2009
Last Update Posted : October 2, 2014
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Parkinson's Disease
Intervention Drug: Rotigotine
Enrollment 124
Recruitment Details 124 patients were screened. 5 patients were run-in failures and 3 patients were screen failures. 116 patients started treatment, i.e. were included into the Safety Set. 114 patients were included into the Full Analysis Set. 99 patients completed the treatment period. 2 patients withdrew after the treatment period. 97 patients completed the study.
Pre-assignment Details  
Arm/Group Title Rotigotine
Hide Arm/Group Description Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Period Title: Overall Study
Started 124
Start of Treatment - Safety Set 116
Full Analysis Set 114
Treatment Period Completed 99
Completed 97
Not Completed 27
Reason Not Completed
Adverse Event             13
Withdrawal by Subject             1
Protocol Violation             3
Lost to Follow-up             2
Run-In Failure             5
Screen Failure             3
Arm/Group Title Rotigotine
Hide Arm/Group Description Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Baseline Participants 116
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants
<=18 years
0
   0.0%
Between 18 and 65 years
73
  62.9%
>=65 years
43
  37.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 116 participants
60.0  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants
Female
69
  59.5%
Male
47
  40.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 116 participants
116
1.Primary Outcome
Title Change in Pulse Rate (Supine, After 1 Minute)
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 112
Mean (Standard Deviation)
Unit of Measure: beats per minute
2.0  (9.4)
2.Primary Outcome
Title Change in Systolic Blood Pressure (Supine, After 1 Minute)
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 112
Mean (Standard Deviation)
Unit of Measure: mmHg
5.7  (14.1)
3.Primary Outcome
Title Change in Diastolic Blood Pressure (Supine, After 1 Minute)
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 112
Mean (Standard Deviation)
Unit of Measure: mmHg
1.7  (9.6)
4.Primary Outcome
Title Change in Pulse Rate (Supine, After 5 Minutes)
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 112
Mean (Standard Deviation)
Unit of Measure: beats per minute
1.8  (8.8)
5.Primary Outcome
Title Change in Systolic Blood Pressure (Supine, After 5 Minutes)
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 112
Mean (Standard Deviation)
Unit of Measure: mmHg
2.6  (13.1)
6.Primary Outcome
Title Change in Diastolic Blood Pressure (Supine, After 5 Minutes)
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 112
Mean (Standard Deviation)
Unit of Measure: mmHg
0.6  (9.8)
7.Primary Outcome
Title Change in Pulse Rate (Standing, After 1 Minute)
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 112
Mean (Standard Deviation)
Unit of Measure: beats per minute
1.7  (11.8)
8.Primary Outcome
Title Change in Systolic Blood Pressure (Standing, After 1 Minute)
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 112
Mean (Standard Deviation)
Unit of Measure: mmHg
-0.2  (12.7)
9.Primary Outcome
Title Change in Diastolic Blood Pressure (Standing, After 1 Minute)
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 112
Mean (Standard Deviation)
Unit of Measure: mmHg
0.8  (10.1)
10.Primary Outcome
Title Change in Pulse Rate (Standing, After 3 Minutes)
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 112
Mean (Standard Deviation)
Unit of Measure: beats per minute
0.8  (11.1)
11.Primary Outcome
Title Change in Systolic Blood Pressure (Standing, After 3 Minutes)
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 112
Mean (Standard Deviation)
Unit of Measure: mmHg
2.0  (12.4)
12.Primary Outcome
Title Change in Diastolic Blood Pressure (Standing, After 3 Minutes)
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 112
Mean (Standard Deviation)
Unit of Measure: mmHg
0.8  (9.1)
13.Primary Outcome
Title Change in Heart Rate
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: beats per minute
0.5  (8.7)
14.Primary Outcome
Title Change in PR Interval
Hide Description

The PR interval is defined as the period that extends from the onset of atrial depolarization (beginning of the P wave) until the onset of ventricular depolarization (beginning of the QRS complex).

Change = 28 day value minus baseline value.

Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 110
Mean (Standard Deviation)
Unit of Measure: msec
-0.0  (14.6)
15.Primary Outcome
Title Change in QRS Duration
Hide Description

The QRS duration represents the time it takes for ventricular depolarization to occur.

Change = 28 day value minus baseline value.

Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: msec
-1.2  (6.3)
16.Primary Outcome
Title Change in QT Interval
Hide Description

The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization.

Change = 28 day value minus baseline value.

Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: msec
-1.7  (30.5)
17.Primary Outcome
Title Change in QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB)
Hide Description

The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization.

Change = 28 day value minus baseline value.

Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: msec
0.5  (23.1)
18.Primary Outcome
Title Change in Percentage of Basophilic Granulocytes in White Blood Cell Count
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 108
Mean (Standard Deviation)
Unit of Measure: Percentage of white blood cell count
0.01  (0.33)
19.Primary Outcome
Title Change in Percentage of Eosinophilic Granulocytes in White Blood Cell Count
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 108
Mean (Standard Deviation)
Unit of Measure: Percentage of white blood cell count
-0.11  (1.71)
20.Primary Outcome
Title Change in Hematocrit
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: l/l*100
0.09  (1.71)
21.Primary Outcome
Title Change in Hemoglobin
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: g/l
0.8  (5.6)
22.Primary Outcome
Title Change in Percentage of Lymphocytes in White Blood Cell Count
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 108
Mean (Standard Deviation)
Unit of Measure: Percentage of white blood cell count
0.73  (7.12)
23.Primary Outcome
Title Change in Percentage of Monocytes in White Blood Cell Count
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 108
Mean (Standard Deviation)
Unit of Measure: Percentage of white blood cell count
0.96  (8.41)
24.Primary Outcome
Title Change in Percentage of Neutrophilic Granulocytes Segmented in White Blood Cell Count
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 108
Mean (Standard Deviation)
Unit of Measure: Percentage of white blood cell count
-0.40  (12.69)
25.Primary Outcome
Title Change in Platelet Count
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: Giga/l
2.6  (29.5)
26.Primary Outcome
Title Change in Red Blood Cell Count
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: Tera/l
0.023  (0.213)
27.Primary Outcome
Title Change in White Blood Cell Count
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: Giga/l
-0.045  (3.538)
28.Primary Outcome
Title Change in Albumin
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: g/l
-0.5  (2.1)
29.Primary Outcome
Title Change in Alkaline Phosphatase
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: Units/l
-1.4  (16.9)
30.Primary Outcome
Title Change in Blood Urea Nitrogen
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 108
Mean (Standard Deviation)
Unit of Measure: mmol/l
-0.24  (1.75)
31.Primary Outcome
Title Change in Calcium
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: mg/dl
-0.05  (0.30)
32.Primary Outcome
Title Change in Chloride
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 108
Mean (Standard Deviation)
Unit of Measure: mmol/l
-0.4  (2.5)
33.Primary Outcome
Title Change in Creatinine
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: mg/dl
-0.004  (0.101)
34.Primary Outcome
Title Change in Gamma-Glutamyltransferase
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: Units/l
-0.1  (7.5)
35.Primary Outcome
Title Change in Glucose
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: mg/dl
-0.2  (30.0)
36.Primary Outcome
Title Change in Inorganic Phosphate
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: mg/dl
-0.03  (0.52)
37.Primary Outcome
Title Change in Potassium
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 108
Mean (Standard Deviation)
Unit of Measure: mmol/l
0.08  (0.35)
38.Primary Outcome
Title Change in Serum Glutamic Oxaloacetic Transaminase
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: Units/l
-0.1  (7.9)
39.Primary Outcome
Title Change in Glutamic Pyruvic Transaminase
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: Units/l
-0.2  (15.6)
40.Primary Outcome
Title Change in Sodium
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 108
Mean (Standard Deviation)
Unit of Measure: mmol/l
-0.6  (2.2)
41.Primary Outcome
Title Change in Total Bilirubin
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: mg/dl
0.079  (1.133)
42.Primary Outcome
Title Change in Total Protein
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: g/dl
-0.09  (0.36)
43.Primary Outcome
Title Change in Uric Acid
Hide Description Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: µmol/l
-3.80  (35.62)
44.Primary Outcome
Title Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Ears, Eyes, Nose, Mouth, Throat'
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: participants
0
45.Primary Outcome
Title Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Psychiatric'
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: participants
0
46.Primary Outcome
Title Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hematological/Lymphatic Nodes'
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: participants
0
47.Primary Outcome
Title Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Dermatological'
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: participants
1
48.Primary Outcome
Title Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Cardiovascular'
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: participants
0
49.Primary Outcome
Title Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Peripheral Vascular'
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: participants
0
50.Primary Outcome
Title Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Pulmonary'
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: participants
0
51.Primary Outcome
Title Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Musculoskeletal'
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: participants
1
52.Primary Outcome
Title Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hepato-/Gastrointestinal'
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: participants
0
53.Primary Outcome
Title Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Renal/Genitourological'
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: participants
0
54.Primary Outcome
Title Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Metabolic/Endocrine'
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: participants
0
55.Primary Outcome
Title Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Other'
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: participants
0
56.Primary Outcome
Title Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Mental Status'
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: participants
0
57.Primary Outcome
Title Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Deep Tendon Reflexes'
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: participants
0
58.Primary Outcome
Title Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Muscle Strength'
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: participants
0
59.Primary Outcome
Title Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Cranial Nerve Function'
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: participants
0
60.Primary Outcome
Title Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Plantar Reflex'
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: participants
0
61.Primary Outcome
Title Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Gait'
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: participants
1
62.Primary Outcome
Title Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Coordination/Balance'
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: participants
0
63.Primary Outcome
Title Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Involuntary Movements'
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: participants
1
64.Primary Outcome
Title Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Sensory Perception'
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: participants
0
65.Primary Outcome
Title Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Other'
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: participants
0
66.Primary Outcome
Title Completion of Trial From Baseline to End of Treatment
Hide Description [Not Specified]
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 116
Measure Type: Number
Unit of Measure: participants
99
67.Primary Outcome
Title Completion of Trial on the Original Treatment Assignment From Baseline to End of Treatment
Hide Description [Not Specified]
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 116
Measure Type: Number
Unit of Measure: participants
88
68.Primary Outcome
Title Drop-out During the 5 Half-life Overlap Period Due to Adverse Events (AEs)
Hide Description [Not Specified]
Time Frame Baseline, 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 116
Measure Type: Number
Unit of Measure: participants
0
69.Primary Outcome
Title Drop-out Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period
Hide Description [Not Specified]
Time Frame Baseline, 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 116
Measure Type: Number
Unit of Measure: participants
9
70.Primary Outcome
Title Dose Reduction During the 5 Half-life Overlap Period Due to Adverse Events (AEs)
Hide Description [Not Specified]
Time Frame Baseline, 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 116
Measure Type: Number
Unit of Measure: participants
1
71.Primary Outcome
Title Dose Reduction Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period
Hide Description [Not Specified]
Time Frame Baseline, 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 116
Measure Type: Number
Unit of Measure: participants
1
72.Secondary Outcome
Title Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score From Baseline to End of Treatment
Hide Description The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part I measures 'Mentation, Behavior and Mood'. Range: 0 (Best score possible) to 16 (Worst score possible) Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 112
Mean (Standard Deviation)
Unit of Measure: score on scale
-0.5  (1.2)
73.Secondary Outcome
Title Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score From Baseline to End of Treatment
Hide Description The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part II measures 'Activities in Daily Living'. Range: 0 (Best score possible) to 52 (Worst score possible) Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 112
Mean (Standard Deviation)
Unit of Measure: score on scale
-0.9  (3.3)
74.Secondary Outcome
Title Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to End of Treatment
Hide Description The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part III measures 'Motor Examination'. Range: 0 (Best score possible) to 56 (Worst score possible) Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 112
Mean (Standard Deviation)
Unit of Measure: score on scale
-1.9  (5.9)
75.Secondary Outcome
Title Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score From Baseline to End of Treatment
Hide Description The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part IV measures 'Complications of Therapy'. Range: 0 (Best score possible) to 23 (Worst score possible) Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 112
Mean (Standard Deviation)
Unit of Measure: score on scale
-0.4  (1.8)
76.Secondary Outcome
Title Change in Parkinson's Disease Sleep Scale (PDSS) Sum Score From Baseline to End of Treatment
Hide Description

The PDSS is a scale to assess sleep and nocturnal disability in Parkinson's disease.

Range: 0 (Best score possible) to 60 (Worst score possible) Change = 28 day value minus baseline value.

Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 112
Mean (Standard Deviation)
Unit of Measure: score on scale
-0.8  (7.3)
77.Secondary Outcome
Title Change in Epworth Sleepiness Scale (ESS) Sum Score From Baseline to End of Treatment
Hide Description The ESS is a self-administered questionnaire in which the subject rates the probability of his/her dozing during 8 situations that are differently conductive to sleep Range: 0 (Best score possible) to 24 (Worst score possible) Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 55
Mean (Standard Deviation)
Unit of Measure: score on scale
-0.2  (3.2)
78.Secondary Outcome
Title Change in Parkinson's Disease Non-Motor Symptom Assessment Scale (PDNMS) Total Sum Score From Baseline to End of Treatment
Hide Description The PDNMS is a rating by the clinician to assess the severity and frequency of non-motor symptoms in Parkinson's disease patients Range: 0 (Best score possible) to 384 (Worst score possible) Change = 28 day value minus baseline value.
Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: score on scale
-7.9  (19.8)
79.Secondary Outcome
Title Change in Clinical Global Impression (CGI) Item 1 Score From Baseline to End of Treatment
Hide Description

The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.

Item 1 measures 'Severity of Parkinson's Disease'. Range: 1 (Normal, not ill at all) to 7 (Among the most extremely ill patients) Change = 28 day value minus baseline value.

Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 114
Mean (Standard Deviation)
Unit of Measure: score on scale
-0.0  (0.6)
80.Secondary Outcome
Title Clinical Global Impression (CGI) Item 2 Score
Hide Description

The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.

Item 2 measures 'Global Improvement'. Range 1 (Very much improved) to 7 (Very much worse)

Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 113
Mean (Standard Deviation)
Unit of Measure: score on scale
3.6  (1.0)
81.Secondary Outcome
Title Clinical Global Impression (CGI) Item 3.1
Hide Description

The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.

Item 3.1 measures 'Therapeutic Effect'. Range: 1 (Marked - Vast improvement. Complete or nearly complete remission of all symptoms.) to 4 (Unchanged or worse)

Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 114
Measure Type: Number
Unit of Measure: participants
Marked 3
Moderate 20
Minimal 36
Unchanged or Worse 54
Not Assessed 1
82.Secondary Outcome
Title Clinical Global Impression (CGI) Item 3.2
Hide Description

The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.

Item 3.2 measures 'Therapeutic Side Effects'. Range: 1 (None) to 4 (Outweigh the therapeutic effect)

Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 114
Measure Type: Number
Unit of Measure: participants
None 88
No Significant Interference with Subj. Functioning 18
Significant Interference with Subj. Functioning 5
Outweigh the Theraputic Effect 2
Not Assessed 1
83.Secondary Outcome
Title Patient Global Impression (PGI) Item 1 Score
Hide Description

The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.

Item 1 measures 'Global Improvement'. Range: 1 (Very much improved) to 7 (Very much worse)

Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 112
Mean (Standard Deviation)
Unit of Measure: score on scale
3.6  (1.2)
84.Secondary Outcome
Title Patient Global Impression (PGI) Item 2
Hide Description

The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.

Item 2 measures 'Therapeutic Effect'. Range: 1 (Marked - Vast improvement. Complete or nearly complete remission of all symptoms) to 4 (Unchanged or worse)

Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 114
Measure Type: Number
Unit of Measure: participants
Marked 5
Moderate 25
Minimal 38
Unchanged or Worse 44
Missing / Not Done 2
85.Secondary Outcome
Title Patient Global Impression (PGI) Item 3
Hide Description

The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.

Item 3 measures 'Side Effects'. Range: 1 (I have no side effects) to 4 (They outweigh the therapeutic effect of the trial medication)

Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 114
Measure Type: Number
Unit of Measure: participants
No Side Effects 77
No Significant Interference with Functioning 24
Significant Interference with Functioning 6
Outweighing Therapeutic Effect of Trial Medication 5
Missing / Not Done 2
86.Secondary Outcome
Title Change in Short-form Parkinson's Disease Questionnaire (PDQ-8) Single Index Score From Baseline to End of Treatment
Hide Description

The PDQ-8 is a self-administered 8-item questionnaire that assesses issues associated with Parkinson's disease.

Range: 0 (good health) to 100 (poor health) Change = 28 day value minus baseline value.

Time Frame Baseline, 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set, only patients with non-missing values were analyzed
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 112
Mean (Standard Deviation)
Unit of Measure: score on scale
-3.9  (13.5)
87.Secondary Outcome
Title Patient Treatment Preference Scale Question 1
Hide Description Have you used pharmaceutical treatments for your Parkinson's disease before the study?
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 114
Measure Type: Number
Unit of Measure: participants
yes 114
no 0
88.Secondary Outcome
Title Patient Treatment Preference Scale Question 2
Hide Description Why did you decide to enter this study?
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 114
Measure Type: Number
Unit of Measure: participants
Side effects with oral medicine 14
Oral medicine not effective in controlling sympt. 21
Taking med. several times a day was not convenient 71
Other 40
89.Secondary Outcome
Title Patient Treatment Preference Scale Question 3
Hide Description In comparing the patch and previous oral treatments for Parkinson's disease, how satisfied have you been with oral medication / patch?
Time Frame 28 days
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Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 114
Measure Type: Number
Unit of Measure: participants
Very Dissatisfied with Oral Medication 3
Dissatisfied with Oral Medication 11
Neither Satisfied nor Dissatisfied with Oral Med. 49
Satisfied with Oral Medication 43
Very Satisfied with Oral Medication 6
Assessment for Oral Medication Missing / Not Done 2
Very Dissatisfied with Patch 9
Dissatisfied with Patch 28
Neither Satisfied nor Dissatisfied with Patch 34
Satisfied with Patch 32
Very Satisfied with Patch 9
Assessment for Patch Missing / Not Done 2
90.Secondary Outcome
Title Patient Treatment Preference Scale Question 4
Hide Description I would prefer using a patch over taking a pill or capsule for treatment of my Parkinson's disease.
Time Frame 28 days
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Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 114
Measure Type: Number
Unit of Measure: participants
Strongly Agree 18
Agree 34
Neither Agree nor Disagree 29
Disagree 28
Strongly Disagree 3
Not Done / Missing 2
91.Secondary Outcome
Title Patient Treatment Preference Scale Question 5
Hide Description I would prefer applying one 40cm**2 patch over applying two 20cm**2 patches for treatment of my Parkinson's disease.
Time Frame 28 days
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Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 114
Measure Type: Number
Unit of Measure: participants
Strongly Agree 17
Agree 68
Neither Agree nor Disagree 10
Disagree 13
Strongly Disagree 4
Not Done / Missing 2
92.Secondary Outcome
Title Patient Treatment Preference Scale Question 6
Hide Description What aspects do you like the most about the patch?
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 114
Measure Type: Number
Unit of Measure: participants
Applying the patch once a day 81
Comfortable to wear 28
Does not interfere with my normal activities 61
Do not have to take medicine in public 56
Provides symptom relief all day 46
Convenient 53
Easy to apply 50
Do not have to remember to take med. during day 60
Missing / Not Done 2
93.Secondary Outcome
Title Patient Treatment Preference Scale Question 7
Hide Description What aspects do you like the least about the patch? Check all that apply.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Rotigotine
Hide Arm/Group Description:
Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
Overall Number of Participants Analyzed 114
Measure Type: Number
Unit of Measure: participants
Hard to apply 11
Hard to remove 3
Hard to remove the patch from its pouch 1
Did not stay on for the entire day 80
Uncomfortable to wear 27
Not always covered by clothing 8
Symptom relief did not last all day 29
Not Done / Missing 2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rotigotine
Hide Arm/Group Description Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
All-Cause Mortality
Rotigotine
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Rotigotine
Affected / at Risk (%) # Events
Total   0/116 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rotigotine
Affected / at Risk (%) # Events
Total   45/116 (38.79%)    
Gastrointestinal disorders   
Dry Mouth * 1  4/116 (3.45%)  4
Dyspepsia * 1  2/116 (1.72%)  2
Constipation * 1  1/116 (0.86%)  1
Nausea * 1  1/116 (0.86%)  1
General disorders   
Asthenia * 1  6/116 (5.17%)  7
Fatigue * 1  2/116 (1.72%)  2
Application site pruritus * 1  3/116 (2.59%)  3
Pain * 1  2/116 (1.72%)  2
Gait disturbence * 1  1/116 (0.86%)  2
Oedema peripheral * 1  1/116 (0.86%)  1
Infections and infestations   
Onychomycosis * 1  1/116 (0.86%)  1
Herpes zoster * 1  1/116 (0.86%)  1
Tinea pedis * 1  1/116 (0.86%)  1
Upper respiratory tract infection * 1  1/116 (0.86%)  1
Metabolism and nutrition disorders   
Anorexia * 1  1/116 (0.86%)  1
Musculoskeletal and connective tissue disorders   
Muscle rigidity * 1  5/116 (4.31%)  5
Back pain * 1  1/116 (0.86%)  1
Nervous system disorders   
Dyskinesia * 1  6/116 (5.17%)  6
Bradykinesia * 1  4/116 (3.45%)  4
Dizziness * 1  7/116 (6.03%)  7
Dizziness postural * 1  1/116 (0.86%)  2
Tremor * 1  7/116 (6.03%)  8
Somnolence * 1  4/116 (3.45%)  4
Parkinson's disease * 1  2/116 (1.72%)  2
Paraesthesia * 1  1/116 (0.86%)  1
Psychiatric disorders   
Confusional state * 1  1/116 (0.86%)  1
Rapid eye movements sleep abnormal * 1  1/116 (0.86%)  1
Hallucination, visual * 1  1/116 (0.86%)  1
Libido increased * 1  1/116 (0.86%)  1
Vascular disorders   
Hypertension * 1  1/116 (0.86%)  1
Orthostatic hypotension * 1  1/116 (0.86%)  1
*
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 days but <= 180 days to review results communications prior to public release and may delete information that 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 results shall be published regardless of outcome.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
Phone: +1 877 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00593606    
Other Study ID Numbers: SP0908
First Submitted: December 21, 2007
First Posted: January 15, 2008
Results First Submitted: December 17, 2008
Results First Posted: May 27, 2009
Last Update Posted: October 2, 2014