Safety and Tolerability Trial of Switching From Ropinirole to Rotigotine

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)   [ Time Frame: Baseline, 28 days ]

2.  Primary:

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

3.  Primary:

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

4.  Primary:

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

5.  Primary:

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

6.  Primary:

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

7.  Primary:

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

8.  Primary:

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

9.  Primary:

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

10.  Primary:

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

11.  Primary:

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

12.  Primary:

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

13.  Primary:

Change in Heart Rate   [ Time Frame: Baseline, 28 days ]

14.  Primary:

Change in PR Interval   [ Time Frame: Baseline, 28 days ]

15.  Primary:

Change in QRS Duration   [ Time Frame: Baseline, 28 days ]

16.  Primary:

Change in QT Interval   [ Time Frame: Baseline, 28 days ]

17.  Primary:

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

18.  Primary:

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

19.  Primary:

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

20.  Primary:

Change in Hematocrit   [ Time Frame: Baseline, 28 days ]

21.  Primary:

Change in Hemoglobin   [ Time Frame: Baseline, 28 days ]

22.  Primary:

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

23.  Primary:

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

24.  Primary:

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

25.  Primary:

Change in Platelet Count   [ Time Frame: Baseline, 28 days ]

26.  Primary:

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

27.  Primary:

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

28.  Primary:

Change in Albumin   [ Time Frame: Baseline, 28 days ]

29.  Primary:

Change in Alkaline Phosphatase   [ Time Frame: Baseline, 28 days ]

30.  Primary:

Change in Blood Urea Nitrogen   [ Time Frame: Baseline, 28 days ]

31.  Primary:

Change in Calcium   [ Time Frame: Baseline, 28 days ]

32.  Primary:

Change in Chloride   [ Time Frame: Baseline, 28 days ]

33.  Primary:

Change in Creatinine   [ Time Frame: Baseline, 28 days ]

34.  Primary:

Change in Gamma-Glutamyltransferase   [ Time Frame: Baseline, 28 days ]

35.  Primary:

Change in Glucose   [ Time Frame: Baseline, 28 days ]

36.  Primary:

Change in Inorganic Phosphate   [ Time Frame: Baseline, 28 days ]

37.  Primary:

Change in Potassium   [ Time Frame: Baseline, 28 days ]

38.  Primary:

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

39.  Primary:

Change in Glutamic Pyruvic Transaminase   [ Time Frame: Baseline, 28 days ]

40.  Primary:

Change in Sodium   [ Time Frame: Baseline, 28 days ]

41.  Primary:

Change in Total Bilirubin   [ Time Frame: Baseline, 28 days ]

42.  Primary:

Change in Total Protein   [ Time Frame: Baseline, 28 days ]

43.  Primary:

Change in Uric Acid   [ Time Frame: Baseline, 28 days ]

44.  Primary:

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

45.  Primary:

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

46.  Primary:

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

47.  Primary:

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

48.  Primary:

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

49.  Primary:

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

50.  Primary:

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

51.  Primary:

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

52.  Primary:

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

53.  Primary:

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

54.  Primary:

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

55.  Primary:

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

56.  Primary:

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

57.  Primary:

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

58.  Primary:

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

59.  Primary:

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

60.  Primary:

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

61.  Primary:

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

62.  Primary:

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

63.  Primary:

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

64.  Primary:

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

65.  Primary:

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

66.  Primary:

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

67.  Primary:

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

68.  Primary:

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

69.  Primary:

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

70.  Primary:

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

71.  Primary:

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

72.  Secondary:

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

73.  Secondary:

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

74.  Secondary:

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

75.  Secondary:

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

76.  Secondary:

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

77.  Secondary:

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

79.  Secondary:

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

80.  Secondary:

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

81.  Secondary:

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

82.  Secondary:

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

83.  Secondary:

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

84.  Secondary:

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

85.  Secondary:

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

86.  Secondary:

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

87.  Secondary:

Patient Treatment Preference Scale Question 1   [ Time Frame: 28 days ]

88.  Secondary:

Patient Treatment Preference Scale Question 2   [ Time Frame: 28 days ]

89.  Secondary:

Patient Treatment Preference Scale Question 3   [ Time Frame: 28 days ]

90.  Secondary:

Patient Treatment Preference Scale Question 4   [ Time Frame: 28 days ]

91.  Secondary:

Patient Treatment Preference Scale Question 5   [ Time Frame: 28 days ]

92.  Secondary:

Patient Treatment Preference Scale Question 6   [ Time Frame: 28 days ]

93.  Secondary:

Patient Treatment Preference Scale Question 7   [ Time Frame: 28 days ]