Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
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.

Participant Flow:   Overall Study

	Rotigotine
STARTED	124
Start of Treatment - Safety Set	116
Full Analysis Set	114
Treatment Period Completed	99
COMPLETED	97
NOT COMPLETED	27
Adverse Event	13
Withdrawal by Subject	1
Protocol Violation	3
Lost to Follow-up	2
Run-In Failure	5
Screen Failure	3

Reporting Groups

	Description
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.

Baseline Measures

	Rotigotine
Number of Participants   [units: participants]	116
Age   [units: participants]
<=18 years	0
Between 18 and 65 years	73
>=65 years	43
Age   [units: years] Mean ± Standard Deviation	60.0 ± 10.1
Gender   [units: participants]
Female	69
Male	47
Region of Enrollment   [units: participants]
Korea, Republic of	116

1.  Primary:

Change in Pulse Rate (Supine, After 1 Minute)   [ Baseline, 28 days ]

2.  Primary:

Change in Systolic Blood Pressure (Supine, After 1 Minute)   [ Baseline, 28 days ]

3.  Primary:

Change in Diastolic Blood Pressure (Supine, After 1 Minute)   [ Baseline, 28 days ]

4.  Primary:

Change in Pulse Rate (Supine, After 5 Minutes)   [ Baseline, 28 days ]

5.  Primary:

Change in Systolic Blood Pressure (Supine, After 5 Minutes)   [ Baseline, 28 Days ]

6.  Primary:

Change in Diastolic Blood Pressure (Supine, After 5 Minutes)   [ Baseline, 28 days ]

7.  Primary:

Change in Pulse Rate (Standing, After 1 Minute)   [ Baseline, 28 days ]

8.  Primary:

Change in Systolic Blood Pressure (Standing, After 1 Minute)   [ Baseline, 28 days ]

9.  Primary:

Change in Diastolic Blood Pressure (Standing, After 1 Minute)   [ Baseline, 28 days ]

10.  Primary:

Change in Pulse Rate (Standing, After 3 Minutes)   [ Baseline, 28 days ]

11.  Primary:

Change in Systolic Blood Pressure (Standing, After 3 Minutes)   [ Baseline, 28 days ]

12.  Primary:

Change in Diastolic Blood Pressure (Standing, After 3 Minutes)   [ Baseline, 28 days ]

13.  Primary:

Change in Heart Rate   [ Baseline, 28 days ]

14.  Primary:

Change in PR Interval   [ Baseline, 28 days ]

15.  Primary:

Change in QRS Duration   [ Baseline, 28 days ]

16.  Primary:

Change in QT Interval   [ Baseline, 28 days ]

17.  Primary:

Change in QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB)   [ Baseline, 28 days ]

18.  Primary:

Change in Percentage of Basophilic Granulocytes in White Blood Cell Count   [ Baseline, 28 days ]

19.  Primary:

Change in Percentage of Eosinophilic Granulocytes in White Blood Cell Count   [ Baseline, 28 days ]

20.  Primary:

Change in Hematocrit   [ Baseline, 28 days ]

21.  Primary:

Change in Hemoglobin   [ Baseline, 28 days ]

22.  Primary:

Change in Percentage of Lymphocytes in White Blood Cell Count   [ Baseline, 28 days ]

23.  Primary:

Change in Percentage of Monocytes in White Blood Cell Count   [ Baseline, 28 days ]

24.  Primary:

Change in Percentage of Neutrophilic Granulocytes Segmented in White Blood Cell Count   [ Baseline, 28 days ]

25.  Primary:

Change in Platelet Count   [ Baseline, 28 days ]

26.  Primary:

Change in Red Blood Cell Count   [ Baseline, 28 days ]

27.  Primary:

Change in White Blood Cell Count   [ Baseline, 28 days ]

28.  Primary:

Change in Albumin   [ Baseline, 28 days ]

29.  Primary:

Change in Alkaline Phosphatase   [ Baseline, 28 days ]

30.  Primary:

Change in Blood Urea Nitrogen   [ Baseline, 28 days ]

31.  Primary:

Change in Calcium   [ Baseline, 28 days ]

32.  Primary:

Change in Chloride   [ Baseline, 28 days ]

33.  Primary:

Change in Creatinine   [ Baseline, 28 days ]

34.  Primary:

Change in Gamma-Glutamyltransferase   [ Baseline, 28 days ]

35.  Primary:

Change in Glucose   [ Baseline, 28 days ]

36.  Primary:

Change in Inorganic Phosphate   [ Baseline, 28 days ]

37.  Primary:

Change in Potassium   [ Baseline, 28 days ]

38.  Primary:

Change in Serum Glutamic Oxaloacetic Transaminase   [ Baseline, 28 days ]

39.  Primary:

Change in Glutamic Pyruvic Transaminase   [ Baseline, 28 days ]

40.  Primary:

Change in Sodium   [ Baseline, 28 days ]

41.  Primary:

Change in Total Bilirubin   [ Baseline, 28 days ]

42.  Primary:

Change in Total Protein   [ Baseline, 28 days ]

43.  Primary:

Change in Uric Acid   [ Baseline, 28 days ]

44.  Primary:

Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Ears, Eyes, Nose, Mouth, Throat’   [ 28 days ]

45.  Primary:

Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Psychiatric’   [ 28 days ]

46.  Primary:

Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Hematological/Lymphatic Nodes’   [ 28 days ]

47.  Primary:

Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Dermatological’   [ 28 days ]

48.  Primary:

Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Cardiovascular’   [ 28 days ]

49.  Primary:

Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Peripheral Vascular’   [ 28 days ]

50.  Primary:

Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Pulmonary’   [ 28 days ]

51.  Primary:

Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Musculoskeletal’   [ 28 days ]

52.  Primary:

Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Hepato-/Gastrointestinal’   [ 28 days ]

53.  Primary:

Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Renal/Genitourological’   [ 28 days ]

54.  Primary:

Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Metabolic/Endocrine’   [ 28 days ]

55.  Primary:

Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for ‘Other’   [ 28 days ]

56.  Primary:

Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Mental Status’   [ 28 days ]

57.  Primary:

Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Deep Tendon Reflexes’   [ 28 days ]

58.  Primary:

Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Muscle Strength’   [ 28 days ]

59.  Primary:

Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Cranial Nerve Function’   [ 28 days ]

60.  Primary:

Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Plantar Reflex’   [ 28 days ]

61.  Primary:

Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Gait’   [ 28 days ]

62.  Primary:

Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Coordination/Balance’   [ 28 days ]

63.  Primary:

Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Involuntary Movements’   [ 28 days ]

64.  Primary:

Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Sensory Perception’   [ 28 days ]

65.  Primary:

Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for ‘Other’   [ 28 days ]

66.  Primary:

Completion of Trial From Baseline to End of Treatment   [ Baseline, 28 days ]

67.  Primary:

Completion of Trial on the Original Treatment Assignment From Baseline to End of Treatment   [ Baseline, 28 days ]

68.  Primary:

Drop-out During the 5 Half-life Overlap Period Due to Adverse Events (AEs)   [ Baseline, 2 days ]

69.  Primary:

Drop-out Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period   [ Baseline, 56 days ]

70.  Primary:

Dose Reduction During the 5 Half-life Overlap Period Due to Adverse Events (AEs)   [ Baseline, 2 days ]

71.  Primary:

Dose Reduction Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period   [ Baseline, 56 days ]

72.  Secondary:

Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score From Baseline to End of Treatment   [ Baseline, 28 days ]

73.  Secondary:

Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score From Baseline to End of Treatment   [ Baseline, 28 days ]

74.  Secondary:

Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to End of Treatment   [ Baseline, 28 days ]

75.  Secondary:

Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score From Baseline to End of Treatment   [ Baseline, 28 days ]

76.  Secondary:

Change in Parkinson’s Disease Sleep Scale (PDSS) Sum Score From Baseline to End of Treatment   [ Baseline, 28 days ]

77.  Secondary:

Change in Epworth Sleepiness Scale (ESS) Sum Score From Baseline to End of Treatment   [ Baseline, 28 days ]

78.  Secondary:

Change in Parkinson’s Disease Non-Motor Symptom Assessment Scale (PDNMS) Total Sum Score From Baseline to End of Treatment   [ Baseline, 28 days ]

79.  Secondary:

Change in Clinical Global Impression (CGI) Item 1 Score From Baseline to End of Treatment   [ Baseline, 28 days ]

80.  Secondary:

Clinical Global Impression (CGI) Item 2 Score   [ 28 days ]

81.  Secondary:

Clinical Global Impression (CGI) Item 3.1   [ 28 days ]

82.  Secondary:

Clinical Global Impression (CGI) Item 3.2   [ 28 days ]

83.  Secondary:

Patient Global Impression (PGI) Item 1 Score   [ 28 days ]

84.  Secondary:

Patient Global Impression (PGI) Item 2   [ 28 days ]

85.  Secondary:

Patient Global Impression (PGI) Item 3   [ 28 days ]

86.  Secondary:

Change in Short-form Parkinson's Disease Questionnaire (PDQ-8) Single Index Score From Baseline to End of Treatment   [ Baseline, 28 days ]

87.  Secondary:

Patient Treatment Preference Scale Question 1   [ 28 days ]

88.  Secondary:

Patient Treatment Preference Scale Question 2   [ 28 days ]

89.  Secondary:

Patient Treatment Preference Scale Question 3   [ 28 days ]

90.  Secondary:

Patient Treatment Preference Scale Question 4   [ 28 days ]

91.  Secondary:

Patient Treatment Preference Scale Question 5   [ 28 days ]

92.  Secondary:

Patient Treatment Preference Scale Question 6   [ 28 days ]

93.  Secondary:

Patient Treatment Preference Scale Question 7   [ 28 days ]