Trial Outcomes & Findings for Safety and Tolerability Trial of Switching From Ropinirole to Rotigotine (NCT NCT00593606)

NCT ID: NCT00593606

Last Updated: 2014-10-02

Results Overview

Change = 28 day value minus baseline value.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 124 participants
• Primary outcome timeframe: Baseline, 28 days
• Results posted on: 2014-10-02

Participant Flow

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.

Participant milestones

Measure	Rotigotine 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 Study STARTED	124
Overall Study Start of Treatment - Safety Set	116
Overall Study Full Analysis Set	114
Overall Study Treatment Period Completed	99
Overall Study COMPLETED	97
Overall Study NOT COMPLETED	27

Reasons for withdrawal

Measure	Rotigotine 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 Study Adverse Event	13
Overall Study Withdrawal by Subject	1
Overall Study Protocol Violation	3
Overall Study Lost to Follow-up	2
Overall Study Run-In Failure	5
Overall Study Screen Failure	3

Baseline Characteristics

Safety and Tolerability Trial of Switching From Ropinirole to Rotigotine

Baseline characteristics by cohort

Measure	Rotigotine n=116 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	73 Participants n=5 Participants
Age, Categorical >=65 years	43 Participants n=5 Participants
Age, Continuous	60.0 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	69 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants
Region of Enrollment Korea, Republic of	116 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=112 Participants 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.
Change in Pulse Rate (Supine, After 1 Minute)	2.0 beats per minute Standard Deviation 9.4

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=112 Participants 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.
Change in Systolic Blood Pressure (Supine, After 1 Minute)	5.7 mmHg Standard Deviation 14.1

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=112 Participants 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.
Change in Diastolic Blood Pressure (Supine, After 1 Minute)	1.7 mmHg Standard Deviation 9.6

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=112 Participants 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.
Change in Pulse Rate (Supine, After 5 Minutes)	1.8 beats per minute Standard Deviation 8.8

PRIMARY outcome

Timeframe: Baseline, 28 Days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=112 Participants 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.
Change in Systolic Blood Pressure (Supine, After 5 Minutes)	2.6 mmHg Standard Deviation 13.1

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=112 Participants 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.
Change in Diastolic Blood Pressure (Supine, After 5 Minutes)	0.6 mmHg Standard Deviation 9.8

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=112 Participants 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.
Change in Pulse Rate (Standing, After 1 Minute)	1.7 beats per minute Standard Deviation 11.8

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=112 Participants 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.
Change in Systolic Blood Pressure (Standing, After 1 Minute)	-0.2 mmHg Standard Deviation 12.7

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=112 Participants 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.
Change in Diastolic Blood Pressure (Standing, After 1 Minute)	0.8 mmHg Standard Deviation 10.1

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=112 Participants 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.
Change in Pulse Rate (Standing, After 3 Minutes)	0.8 beats per minute Standard Deviation 11.1

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=112 Participants 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.
Change in Systolic Blood Pressure (Standing, After 3 Minutes)	2.0 mmHg Standard Deviation 12.4

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=112 Participants 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.
Change in Diastolic Blood Pressure (Standing, After 3 Minutes)	0.8 mmHg Standard Deviation 9.1

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=111 Participants 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.
Change in Heart Rate	0.5 beats per minute Standard Deviation 8.7

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

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.

Outcome measures

Measure	Rotigotine n=110 Participants 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.
Change in PR Interval	-0.0 msec Standard Deviation 14.6

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

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

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=111 Participants 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.
Change in QRS Duration	-1.2 msec Standard Deviation 6.3

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

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.

Outcome measures

Measure	Rotigotine n=111 Participants 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.
Change in QT Interval	-1.7 msec Standard Deviation 30.5

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

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.

Outcome measures

Measure	Rotigotine n=111 Participants 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.
Change in QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB)	0.5 msec Standard Deviation 23.1

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=108 Participants 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.
Change in Percentage of Basophilic Granulocytes in White Blood Cell Count	0.01 Percentage of white blood cell count Standard Deviation 0.33

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=108 Participants 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.
Change in Percentage of Eosinophilic Granulocytes in White Blood Cell Count	-0.11 Percentage of white blood cell count Standard Deviation 1.71

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=111 Participants 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.
Change in Hematocrit	0.09 l/l*100 Standard Deviation 1.71

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=111 Participants 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.
Change in Hemoglobin	0.8 g/l Standard Deviation 5.6

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=108 Participants 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.
Change in Percentage of Lymphocytes in White Blood Cell Count	0.73 Percentage of white blood cell count Standard Deviation 7.12

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=108 Participants 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.
Change in Percentage of Monocytes in White Blood Cell Count	0.96 Percentage of white blood cell count Standard Deviation 8.41

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=108 Participants 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.
Change in Percentage of Neutrophilic Granulocytes Segmented in White Blood Cell Count	-0.40 Percentage of white blood cell count Standard Deviation 12.69

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=111 Participants 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.
Change in Platelet Count	2.6 Giga/l Standard Deviation 29.5

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=111 Participants 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.
Change in Red Blood Cell Count	0.023 Tera/l Standard Deviation 0.213

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=111 Participants 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.
Change in White Blood Cell Count	-0.045 Giga/l Standard Deviation 3.538

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=111 Participants 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.
Change in Albumin	-0.5 g/l Standard Deviation 2.1

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=111 Participants 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.
Change in Alkaline Phosphatase	-1.4 Units/l Standard Deviation 16.9

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=108 Participants 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.
Change in Blood Urea Nitrogen	-0.24 mmol/l Standard Deviation 1.75

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=111 Participants 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.
Change in Calcium	-0.05 mg/dl Standard Deviation 0.30

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=108 Participants 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.
Change in Chloride	-0.4 mmol/l Standard Deviation 2.5

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=111 Participants 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.
Change in Creatinine	-0.004 mg/dl Standard Deviation 0.101

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=111 Participants 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.
Change in Gamma-Glutamyltransferase	-0.1 Units/l Standard Deviation 7.5

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=111 Participants 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.
Change in Glucose	-0.2 mg/dl Standard Deviation 30.0

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=111 Participants 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.
Change in Inorganic Phosphate	-0.03 mg/dl Standard Deviation 0.52

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=108 Participants 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.
Change in Potassium	0.08 mmol/l Standard Deviation 0.35

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=111 Participants 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.
Change in Serum Glutamic Oxaloacetic Transaminase	-0.1 Units/l Standard Deviation 7.9

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=111 Participants 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.
Change in Glutamic Pyruvic Transaminase	-0.2 Units/l Standard Deviation 15.6

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=108 Participants 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.
Change in Sodium	-0.6 mmol/l Standard Deviation 2.2

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=111 Participants 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.
Change in Total Bilirubin	0.079 mg/dl Standard Deviation 1.133

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=111 Participants 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.
Change in Total Protein	-0.09 g/dl Standard Deviation 0.36

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Change = 28 day value minus baseline value.

Outcome measures

Measure	Rotigotine n=111 Participants 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.
Change in Uric Acid	-3.80 µmol/l Standard Deviation 35.62

PRIMARY outcome

Timeframe: 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Outcome measures

Measure	Rotigotine n=113 Participants 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.
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Ears, Eyes, Nose, Mouth, Throat'	0 participants

PRIMARY outcome

Timeframe: 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Outcome measures

Measure	Rotigotine n=113 Participants 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.
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Psychiatric'	0 participants

PRIMARY outcome

Timeframe: 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Outcome measures

Measure	Rotigotine n=113 Participants 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.
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hematological/Lymphatic Nodes'	0 participants

PRIMARY outcome

Timeframe: 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Outcome measures

Measure	Rotigotine n=113 Participants 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.
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Dermatological'	1 participants

PRIMARY outcome

Timeframe: 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Outcome measures

Measure	Rotigotine n=113 Participants 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.
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Cardiovascular'	0 participants

PRIMARY outcome

Timeframe: 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Outcome measures

Measure	Rotigotine n=113 Participants 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.
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Peripheral Vascular'	0 participants

PRIMARY outcome

Timeframe: 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Outcome measures

Measure	Rotigotine n=113 Participants 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.
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Pulmonary'	0 participants

PRIMARY outcome

Timeframe: 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Outcome measures

Measure	Rotigotine n=113 Participants 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.
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Musculoskeletal'	1 participants

PRIMARY outcome

Timeframe: 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Outcome measures

Measure	Rotigotine n=113 Participants 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.
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hepato-/Gastrointestinal'	0 participants

PRIMARY outcome

Timeframe: 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Outcome measures

Measure	Rotigotine n=113 Participants 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.
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Renal/Genitourological'	0 participants

PRIMARY outcome

Timeframe: 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Outcome measures

Measure	Rotigotine n=113 Participants 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.
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Metabolic/Endocrine'	0 participants

PRIMARY outcome

Timeframe: 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Outcome measures

Measure	Rotigotine n=113 Participants 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.
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Other'	0 participants

PRIMARY outcome

Timeframe: 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Outcome measures

Measure	Rotigotine n=113 Participants 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.
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Mental Status'	0 participants

PRIMARY outcome

Timeframe: 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Outcome measures

Measure	Rotigotine n=113 Participants 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.
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Deep Tendon Reflexes'	0 participants

PRIMARY outcome

Timeframe: 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Outcome measures

Measure	Rotigotine n=113 Participants 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.
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Muscle Strength'	0 participants

PRIMARY outcome

Timeframe: 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Outcome measures

Measure	Rotigotine n=113 Participants 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.
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Cranial Nerve Function'	0 participants

PRIMARY outcome

Timeframe: 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Outcome measures

Measure	Rotigotine n=113 Participants 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.
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Plantar Reflex'	0 participants

PRIMARY outcome

Timeframe: 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Outcome measures

Measure	Rotigotine n=113 Participants 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.
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Gait'	1 participants

PRIMARY outcome

Timeframe: 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Outcome measures

Measure	Rotigotine n=113 Participants 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.
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Coordination/Balance'	0 participants

PRIMARY outcome

Timeframe: 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Outcome measures

Measure	Rotigotine n=113 Participants 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.
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Involuntary Movements'	1 participants

PRIMARY outcome

Timeframe: 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Outcome measures

Measure	Rotigotine n=113 Participants 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.
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Sensory Perception'	0 participants

PRIMARY outcome

Timeframe: 28 days

Population: Safety Set, only patients with non-missing values were analyzed

Outcome measures

Measure	Rotigotine n=113 Participants 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.
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Other'	0 participants

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set

Outcome measures

Measure	Rotigotine n=116 Participants 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.
Completion of Trial From Baseline to End of Treatment	99 participants

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Safety Set

Outcome measures

Measure	Rotigotine n=116 Participants 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.
Completion of Trial on the Original Treatment Assignment From Baseline to End of Treatment	88 participants

PRIMARY outcome

Timeframe: Baseline, 2 days

Population: Safety Set

Outcome measures

Measure	Rotigotine n=116 Participants 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.
Drop-out During the 5 Half-life Overlap Period Due to Adverse Events (AEs)	0 participants

PRIMARY outcome

Timeframe: Baseline, 56 days

Population: Safety Set

Outcome measures

Measure	Rotigotine n=116 Participants 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.
Drop-out Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period	9 participants

PRIMARY outcome

Timeframe: Baseline, 2 days

Population: Safety Set

Outcome measures

Measure	Rotigotine n=116 Participants 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.
Dose Reduction During the 5 Half-life Overlap Period Due to Adverse Events (AEs)	1 participants

PRIMARY outcome

Timeframe: Baseline, 56 days

Population: Safety Set

Outcome measures

Measure	Rotigotine n=116 Participants 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.
Dose Reduction Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period	1 participants

SECONDARY outcome

Timeframe: Baseline, 28 days

Population: Full Analysis Set, only patients with non-missing values were analyzed

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.

Outcome measures

Measure	Rotigotine n=112 Participants 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.
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score From Baseline to End of Treatment	-0.5 score on scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: Baseline, 28 days

Population: Full Analysis Set, only patients with non-missing values were analyzed

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.

Outcome measures

Measure	Rotigotine n=112 Participants 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.
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score From Baseline to End of Treatment	-0.9 score on scale Standard Deviation 3.3

SECONDARY outcome

Timeframe: Baseline, 28 days

Population: Full Analysis Set, only patients with non-missing values were analyzed

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.

Outcome measures

Measure	Rotigotine n=112 Participants 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.
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to End of Treatment	-1.9 score on scale Standard Deviation 5.9

SECONDARY outcome

Timeframe: Baseline, 28 days

Population: Full Analysis Set, only patients with non-missing values were analyzed

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.

Outcome measures

Measure	Rotigotine n=112 Participants 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.
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score From Baseline to End of Treatment	-0.4 score on scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: Baseline, 28 days

Population: Full Analysis Set, only patients with non-missing values were analyzed

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.

Outcome measures

Measure	Rotigotine n=112 Participants 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.
Change in Parkinson's Disease Sleep Scale (PDSS) Sum Score From Baseline to End of Treatment	-0.8 score on scale Standard Deviation 7.3

SECONDARY outcome

Timeframe: Baseline, 28 days

Population: Full Analysis Set, only patients with non-missing values were analyzed

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.

Outcome measures

Measure	Rotigotine n=55 Participants 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.
Change in Epworth Sleepiness Scale (ESS) Sum Score From Baseline to End of Treatment	-0.2 score on scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: Baseline, 28 days

Population: Full Analysis Set, only patients with non-missing values were analyzed

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.

Outcome measures

Measure	Rotigotine n=111 Participants 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.
Change in Parkinson's Disease Non-Motor Symptom Assessment Scale (PDNMS) Total Sum Score From Baseline to End of Treatment	-7.9 score on scale Standard Deviation 19.8

SECONDARY outcome

Timeframe: Baseline, 28 days

Population: Full Analysis Set

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.

Outcome measures

Measure	Rotigotine n=114 Participants 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.
Change in Clinical Global Impression (CGI) Item 1 Score From Baseline to End of Treatment	-0.0 score on scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: 28 days

Population: Full Analysis Set, only patients with non-missing values were analyzed

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)

Outcome measures

Measure	Rotigotine n=113 Participants 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.
Clinical Global Impression (CGI) Item 2 Score	3.6 score on scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: 28 days

Population: Full Analysis Set

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)

Outcome measures

Measure	Rotigotine n=114 Participants 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.
Clinical Global Impression (CGI) Item 3.1 Marked	3 participants
Clinical Global Impression (CGI) Item 3.1 Moderate	20 participants
Clinical Global Impression (CGI) Item 3.1 Minimal	36 participants
Clinical Global Impression (CGI) Item 3.1 Unchanged or Worse	54 participants
Clinical Global Impression (CGI) Item 3.1 Not Assessed	1 participants

SECONDARY outcome

Timeframe: 28 days

Population: Full Analysis Set

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)

Outcome measures

Measure	Rotigotine n=114 Participants 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.
Clinical Global Impression (CGI) Item 3.2 Significant Interference with Subj. Functioning	5 participants
Clinical Global Impression (CGI) Item 3.2 Outweigh the Theraputic Effect	2 participants
Clinical Global Impression (CGI) Item 3.2 None	88 participants
Clinical Global Impression (CGI) Item 3.2 No Significant Interference with Subj. Functioning	18 participants
Clinical Global Impression (CGI) Item 3.2 Not Assessed	1 participants

SECONDARY outcome

Timeframe: 28 days

Population: Full Analysis Set, only patients with non-missing values were analyzed

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)

Outcome measures

Measure	Rotigotine n=112 Participants 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.
Patient Global Impression (PGI) Item 1 Score	3.6 score on scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: 28 days

Population: Full Analysis Set

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)

Outcome measures

Measure	Rotigotine n=114 Participants 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.
Patient Global Impression (PGI) Item 2 Unchanged or Worse	44 participants
Patient Global Impression (PGI) Item 2 Missing / Not Done	2 participants
Patient Global Impression (PGI) Item 2 Marked	5 participants
Patient Global Impression (PGI) Item 2 Moderate	25 participants
Patient Global Impression (PGI) Item 2 Minimal	38 participants

SECONDARY outcome

Timeframe: 28 days

Population: Full Analysis Set

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)

Outcome measures

Measure	Rotigotine n=114 Participants 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.
Patient Global Impression (PGI) Item 3 No Side Effects	77 participants
Patient Global Impression (PGI) Item 3 No Significant Interference with Functioning	24 participants
Patient Global Impression (PGI) Item 3 Significant Interference with Functioning	6 participants
Patient Global Impression (PGI) Item 3 Outweighing Therapeutic Effect of Trial Medication	5 participants
Patient Global Impression (PGI) Item 3 Missing / Not Done	2 participants

SECONDARY outcome

Timeframe: Baseline, 28 days

Population: Full Analysis Set, only patients with non-missing values were analyzed

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.

Outcome measures

Measure	Rotigotine n=112 Participants 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.
Change in Short-form Parkinson's Disease Questionnaire (PDQ-8) Single Index Score From Baseline to End of Treatment	-3.9 score on scale Standard Deviation 13.5

SECONDARY outcome

Timeframe: 28 days

Population: Full Analysis Set

Have you used pharmaceutical treatments for your Parkinson's disease before the study?

Outcome measures

Measure	Rotigotine n=114 Participants 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.
Patient Treatment Preference Scale Question 1 yes	114 participants
Patient Treatment Preference Scale Question 1 no	0 participants

SECONDARY outcome

Timeframe: 28 days

Population: Full Analysis Set

Why did you decide to enter this study?

Outcome measures

Measure	Rotigotine n=114 Participants 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.
Patient Treatment Preference Scale Question 2 Other	40 participants
Patient Treatment Preference Scale Question 2 Side effects with oral medicine	14 participants
Patient Treatment Preference Scale Question 2 Oral medicine not effective in controlling sympt.	21 participants
Patient Treatment Preference Scale Question 2 Taking med. several times a day was not convenient	71 participants

SECONDARY outcome

Timeframe: 28 days

Population: Full Analysis Set

In comparing the patch and previous oral treatments for Parkinson's disease, how satisfied have you been with oral medication / patch?

Outcome measures

Measure	Rotigotine n=114 Participants 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.
Patient Treatment Preference Scale Question 3 Neither Satisfied nor Dissatisfied with Patch	34 participants
Patient Treatment Preference Scale Question 3 Satisfied with Patch	32 participants
Patient Treatment Preference Scale Question 3 Very Satisfied with Patch	9 participants
Patient Treatment Preference Scale Question 3 Assessment for Patch Missing / Not Done	2 participants
Patient Treatment Preference Scale Question 3 Very Dissatisfied with Oral Medication	3 participants
Patient Treatment Preference Scale Question 3 Dissatisfied with Oral Medication	11 participants
Patient Treatment Preference Scale Question 3 Neither Satisfied nor Dissatisfied with Oral Med.	49 participants
Patient Treatment Preference Scale Question 3 Satisfied with Oral Medication	43 participants
Patient Treatment Preference Scale Question 3 Very Satisfied with Oral Medication	6 participants
Patient Treatment Preference Scale Question 3 Assessment for Oral Medication Missing / Not Done	2 participants
Patient Treatment Preference Scale Question 3 Very Dissatisfied with Patch	9 participants
Patient Treatment Preference Scale Question 3 Dissatisfied with Patch	28 participants

SECONDARY outcome

Timeframe: 28 days

Population: Full Analysis Set

I would prefer using a patch over taking a pill or capsule for treatment of my Parkinson's disease.

Outcome measures

Measure	Rotigotine n=114 Participants 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.
Patient Treatment Preference Scale Question 4 Strongly Agree	18 participants
Patient Treatment Preference Scale Question 4 Agree	34 participants
Patient Treatment Preference Scale Question 4 Neither Agree nor Disagree	29 participants
Patient Treatment Preference Scale Question 4 Disagree	28 participants
Patient Treatment Preference Scale Question 4 Strongly Disagree	3 participants
Patient Treatment Preference Scale Question 4 Not Done / Missing	2 participants

SECONDARY outcome

Timeframe: 28 days

Population: Full Analysis Set

I would prefer applying one 40cm**2 patch over applying two 20cm**2 patches for treatment of my Parkinson's disease.

Outcome measures

Measure	Rotigotine n=114 Participants 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.
Patient Treatment Preference Scale Question 5 Strongly Disagree	4 participants
Patient Treatment Preference Scale Question 5 Not Done / Missing	2 participants
Patient Treatment Preference Scale Question 5 Strongly Agree	17 participants
Patient Treatment Preference Scale Question 5 Agree	68 participants
Patient Treatment Preference Scale Question 5 Neither Agree nor Disagree	10 participants
Patient Treatment Preference Scale Question 5 Disagree	13 participants

SECONDARY outcome

Timeframe: 28 days

Population: Full Analysis Set

What aspects do you like the most about the patch?

Outcome measures

Measure	Rotigotine n=114 Participants 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.
Patient Treatment Preference Scale Question 6 Applying the patch once a day	81 participants
Patient Treatment Preference Scale Question 6 Comfortable to wear	28 participants
Patient Treatment Preference Scale Question 6 Does not interfere with my normal activities	61 participants
Patient Treatment Preference Scale Question 6 Do not have to take medicine in public	56 participants
Patient Treatment Preference Scale Question 6 Missing / Not Done	2 participants
Patient Treatment Preference Scale Question 6 Provides symptom relief all day	46 participants
Patient Treatment Preference Scale Question 6 Convenient	53 participants
Patient Treatment Preference Scale Question 6 Easy to apply	50 participants
Patient Treatment Preference Scale Question 6 Do not have to remember to take med. during day	60 participants

SECONDARY outcome

Timeframe: 28 days

Population: Full Analysis Set

What aspects do you like the least about the patch? Check all that apply.

Outcome measures

Measure	Rotigotine n=114 Participants 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.
Patient Treatment Preference Scale Question 7 Hard to apply	11 participants
Patient Treatment Preference Scale Question 7 Hard to remove	3 participants
Patient Treatment Preference Scale Question 7 Hard to remove the patch from its pouch	1 participants
Patient Treatment Preference Scale Question 7 Did not stay on for the entire day	80 participants
Patient Treatment Preference Scale Question 7 Uncomfortable to wear	27 participants
Patient Treatment Preference Scale Question 7 Not always covered by clothing	8 participants
Patient Treatment Preference Scale Question 7 Symptom relief did not last all day	29 participants
Patient Treatment Preference Scale Question 7 Not Done / Missing	2 participants

Adverse Events

Rotigotine

Serious events: 0 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Rotigotine n=116 participants at risk 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.
Gastrointestinal disorders Dry Mouth	3.4% 4/116 • Number of events 4
Gastrointestinal disorders Dyspepsia	1.7% 2/116 • Number of events 2
Gastrointestinal disorders Constipation	0.86% 1/116 • Number of events 1
Gastrointestinal disorders Nausea	0.86% 1/116 • Number of events 1
General disorders Asthenia	5.2% 6/116 • Number of events 7
General disorders Fatigue	1.7% 2/116 • Number of events 2
General disorders Application site pruritus	2.6% 3/116 • Number of events 3
General disorders Pain	1.7% 2/116 • Number of events 2
General disorders Gait disturbence	0.86% 1/116 • Number of events 2
General disorders Oedema peripheral	0.86% 1/116 • Number of events 1
Infections and infestations Onychomycosis	0.86% 1/116 • Number of events 1
Infections and infestations Herpes zoster	0.86% 1/116 • Number of events 1
Infections and infestations Tinea pedis	0.86% 1/116 • Number of events 1
Infections and infestations Upper respiratory tract infection	0.86% 1/116 • Number of events 1
Metabolism and nutrition disorders Anorexia	0.86% 1/116 • Number of events 1
Musculoskeletal and connective tissue disorders Muscle rigidity	4.3% 5/116 • Number of events 5
Musculoskeletal and connective tissue disorders Back pain	0.86% 1/116 • Number of events 1
Nervous system disorders Dyskinesia	5.2% 6/116 • Number of events 6
Nervous system disorders Bradykinesia	3.4% 4/116 • Number of events 4
Nervous system disorders Dizziness	6.0% 7/116 • Number of events 7
Nervous system disorders Dizziness postural	0.86% 1/116 • Number of events 2
Nervous system disorders Tremor	6.0% 7/116 • Number of events 8
Nervous system disorders Somnolence	3.4% 4/116 • Number of events 4
Nervous system disorders Parkinson's disease	1.7% 2/116 • Number of events 2
Nervous system disorders Paraesthesia	0.86% 1/116 • Number of events 1
Psychiatric disorders Confusional state	0.86% 1/116 • Number of events 1
Psychiatric disorders Rapid eye movements sleep abnormal	0.86% 1/116 • Number of events 1
Psychiatric disorders Hallucination, visual	0.86% 1/116 • Number of events 1
Psychiatric disorders Libido increased	0.86% 1/116 • Number of events 1
Vascular disorders Hypertension	0.86% 1/116 • Number of events 1
Vascular disorders Orthostatic hypotension	0.86% 1/116 • Number of events 1

Additional Information

UCB Clinical Trial Call Center

UCB

Phone: +1 877 822 9493

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER