Trial Outcomes & Findings for Cardiac Effects of Rotigotine Transdermal System in Subjects With Advanced-stage Idiopathic Parkinson's Disease (NCT NCT00292227)

NCT ID: NCT00292227

Last Updated: 2014-10-27

Results Overview

Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 20:00h.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 130 participants
• Primary outcome timeframe: Baseline (Day -2/ Day -1) 20:00h, Day 42 20:00h
• Results posted on: 2014-10-27

Participant Flow

Within the placebo patch group, subjects were randomized to the sequence of receiving either placebo saline iv solution or moxifloxacin iv solution on Days 32 and 39 in a cross-over design. This treatment was in addition to treatment with the placebo patch. Subjects in the rotigotine patch group received placebo iv solution on Day 32 and Day 39.

Participant milestones

Measure	Rotigotine Patch (Infusion: Placebo-Placebo) Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule. Placebo saline solution 250 mL infused over 1 hour on Day 32 and on Day 39.	Placebo Patch (Infusion: Moxifloxacin-Placebo) Placebo Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule. Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour on Day 32. Placebo saline solution 250 mL infused over 1 hour on Day 39.	Placebo Patch (Infusion: Placebo-Moxifloxacin) Placebo Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule. Placebo saline solution 250 mL infused over 1 hour on Day 32. Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour on Day 39.
Patch Period STARTED	66	31	33
Patch Period COMPLETED	65	31	30
Patch Period NOT COMPLETED	1	0	3
Cross-over Period 1 (Day 32) STARTED	65	31	30
Cross-over Period 1 (Day 32) COMPLETED	65	31	30
Cross-over Period 1 (Day 32) NOT COMPLETED	0	0	0
Cross-over Period 2 (Day 39) STARTED	65	31	30
Cross-over Period 2 (Day 39) COMPLETED	65	31	30
Cross-over Period 2 (Day 39) NOT COMPLETED	0	0	0

Reasons for withdrawal

Measure	Rotigotine Patch (Infusion: Placebo-Placebo) Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule. Placebo saline solution 250 mL infused over 1 hour on Day 32 and on Day 39.	Placebo Patch (Infusion: Moxifloxacin-Placebo) Placebo Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule. Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour on Day 32. Placebo saline solution 250 mL infused over 1 hour on Day 39.	Placebo Patch (Infusion: Placebo-Moxifloxacin) Placebo Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule. Placebo saline solution 250 mL infused over 1 hour on Day 32. Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour on Day 39.
Patch Period Adverse Event	1	0	2
Patch Period Withdrawal by Subject	0	0	1

Baseline Characteristics

Cardiac Effects of Rotigotine Transdermal System in Subjects With Advanced-stage Idiopathic Parkinson's Disease

Baseline characteristics by cohort

Measure	Rotigotine Patch n=66 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=64 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Total n=130 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	35 Participants n=7 Participants	65 Participants n=5 Participants
Age, Categorical >=65 years	36 Participants n=5 Participants	29 Participants n=7 Participants	65 Participants n=5 Participants
Age, Continuous	63.5 years STANDARD_DEVIATION 10.4 • n=5 Participants	63.1 years STANDARD_DEVIATION 9.8 • n=7 Participants	63.3 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	44 Participants n=7 Participants	89 Participants n=5 Participants
Region of Enrollment South Africa	66 participants n=5 Participants	64 participants n=7 Participants	130 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day -2/ Day -1) 20:00h, Day 42 20:00h

Population: Safety population; only non-missing values were analyzed.

Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 20:00h.

Outcome measures

Measure	Rotigotine Patch n=65 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI at Time of Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)	0.46 milliseconds [ms] Standard Deviation 5.96	1.13 milliseconds [ms] Standard Deviation 6.86

PRIMARY outcome

Timeframe: Baseline (Day -2/ Day -1) 21:00h, Day 42 21:00h

Population: Safety population; only non-missing values were analyzed.

Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 21:00h.

Outcome measures

Measure	Rotigotine Patch n=65 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 1 Hour After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)	1.82 milliseconds [ms] Standard Deviation 8.32	1.67 milliseconds [ms] Standard Deviation 7.25

PRIMARY outcome

Timeframe: Baseline (Day -2/ Day -1) 22:00h, Day 42 22:00h

Population: Safety population; only non-missing values were analyzed.

Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 22:00h.

Outcome measures

Measure	Rotigotine Patch n=64 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 2 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)	2.55 milliseconds [ms] Standard Deviation 6.96	1.78 milliseconds [ms] Standard Deviation 6.76

PRIMARY outcome

Timeframe: Baseline (Day -2/ Day -1) 23:00h, Day 42 23:00h

Population: Safety population; only non-missing values were analyzed.

Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 23:00h.

Outcome measures

Measure	Rotigotine Patch n=65 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 3 Hours After Patch Application on Day 42(Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)	1.02 milliseconds [ms] Standard Deviation 7.98	0.89 milliseconds [ms] Standard Deviation 6.52

PRIMARY outcome

Timeframe: Baseline (Day -2/ Day -1) 00:00h, Day 43 00:00h

Population: Safety population; only non-missing values were analyzed.

Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 00:00h.

Outcome measures

Measure	Rotigotine Patch n=65 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 4 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)	0.54 milliseconds [ms] Standard Deviation 8.09	0.83 milliseconds [ms] Standard Deviation 7.29

PRIMARY outcome

Timeframe: Baseline (Day -2/ Day -1) 1:00h, Day 43 1:00h

Population: Safety population; only non-missing values were analyzed.

Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 1:00h.

Outcome measures

Measure	Rotigotine Patch n=65 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 5 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)	-0.17 milliseconds [ms] Standard Deviation 7.97	0.03 milliseconds [ms] Standard Deviation 8.11

PRIMARY outcome

Timeframe: Baseline (Day -2/ Day -1) 2:00h, Day 43 2:00h

Population: Safety population; only non-missing values were analyzed.

Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 2:00h.

Outcome measures

Measure	Rotigotine Patch n=64 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 6 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)	-0.62 milliseconds [ms] Standard Deviation 8.57	0.05 milliseconds [ms] Standard Deviation 7.39

PRIMARY outcome

Timeframe: Baseline (Day -2/ Day -1) 3:00h, Day 43 3:00h

Population: Safety population; only non-missing values were analyzed.

Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 3:00h.

Outcome measures

Measure	Rotigotine Patch n=65 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 7 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)	-0.63 milliseconds [ms] Standard Deviation 7.84	-0.26 milliseconds [ms] Standard Deviation 6.44

PRIMARY outcome

Timeframe: Baseline (Day -2/ Day -1) 4:00h, Day 43 4:00h

Population: Safety population; only non-missing values were analyzed.

Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 4:00h.

Outcome measures

Measure	Rotigotine Patch n=65 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 8 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)	-0.31 milliseconds [ms] Standard Deviation 8.41	0.95 milliseconds [ms] Standard Deviation 5.75

PRIMARY outcome

Timeframe: Baseline (Day -2/ Day -1) 5:00h, Day 43 5:00h

Population: Safety population; only non-missing values were analyzed.

Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 5:00h.

Outcome measures

Measure	Rotigotine Patch n=65 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 9 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)	-0.39 milliseconds [ms] Standard Deviation 7.10	-1.97 milliseconds [ms] Standard Deviation 7.12

PRIMARY outcome

Timeframe: Baseline (Day -2/ Day -1) 6:00h, Day 43 6:00h

Population: Safety population; only non-missing values were analyzed.

Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 6:00h.

Outcome measures

Measure	Rotigotine Patch n=63 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 10 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)	0.92 milliseconds [ms] Standard Deviation 7.70	0.58 milliseconds [ms] Standard Deviation 6.52

PRIMARY outcome

Timeframe: Baseline (Day -2/ Day -1) 7:00h, Day 43 7:00h

Population: Safety population; only non-missing values were analyzed.

Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 7:00h.

Outcome measures

Measure	Rotigotine Patch n=62 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=60 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 11 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)	1.94 milliseconds [ms] Standard Deviation 9.64	0.30 milliseconds [ms] Standard Deviation 5.90

PRIMARY outcome

Timeframe: Baseline (Day -2/ Day -1) 8:00h, Day 43 8:00h

Population: Safety population; only non-missing values were analyzed.

Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 8:00h.

Outcome measures

Measure	Rotigotine Patch n=65 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 12 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)	1.16 milliseconds [ms] Standard Deviation 5.65	1.31 milliseconds [ms] Standard Deviation 5.26

PRIMARY outcome

Timeframe: Baseline (Day -2/ Day -1) 9:00h, Day 43 9:00h

Population: Safety population; only non-missing values were analyzed.

Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 9:00h.

Outcome measures

Measure	Rotigotine Patch n=65 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 13 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)	0.83 milliseconds [ms] Standard Deviation 6.70	1.40 milliseconds [ms] Standard Deviation 5.78

PRIMARY outcome

Timeframe: Baseline (Day -2/ Day -1) 10:00h, Day 43 10:00h

Population: Safety population; only non-missing values were analyzed.

Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 10:00h.

Outcome measures

Measure	Rotigotine Patch n=64 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 14 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)	1.83 milliseconds [ms] Standard Deviation 6.96	2.12 milliseconds [ms] Standard Deviation 6.01

PRIMARY outcome

Timeframe: Baseline (Day -2/ Day -1) 11:00h, Day 43 11:00h

Population: Safety population; only non-missing values were analyzed.

Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 11:00h.

Outcome measures

Measure	Rotigotine Patch n=65 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 15 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)	1.15 milliseconds [ms] Standard Deviation 6.42	1.60 milliseconds [ms] Standard Deviation 6.21

PRIMARY outcome

Timeframe: Baseline (Day -2/ Day -1) 12:00h, Day 43 12:00h

Population: Safety population; only non-missing values were analyzed.

Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 12:00h.

Outcome measures

Measure	Rotigotine Patch n=65 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 16 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)	2.21 milliseconds [ms] Standard Deviation 6.96	1.99 milliseconds [ms] Standard Deviation 6.46

PRIMARY outcome

Timeframe: Baseline (Day -2/ Day -1) 13:00h, Day 43 13:00h

Population: Safety population; only non-missing values were analyzed.

Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 13:00h.

Outcome measures

Measure	Rotigotine Patch n=65 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 17 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)	1.35 milliseconds [ms] Standard Deviation 6.10	2.59 milliseconds [ms] Standard Deviation 5.82

PRIMARY outcome

Timeframe: Baseline (Day -2/ Day -1) 14:00h, Day 43 14:00h

Population: Safety population; only non-missing values were analyzed.

Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 14:00h.

Outcome measures

Measure	Rotigotine Patch n=63 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=60 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 18 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)	-0.31 milliseconds [ms] Standard Deviation 8.48	1.29 milliseconds [ms] Standard Deviation 6.43

PRIMARY outcome

Timeframe: Baseline (Day -2/ Day -1) 15:00h, Day 43 15:00h

Population: Safety population; only non-missing values were analyzed.

Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 15:00h.

Outcome measures

Measure	Rotigotine Patch n=64 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 19 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)	0.71 milliseconds [ms] Standard Deviation 6.01	1.51 milliseconds [ms] Standard Deviation 5.65

PRIMARY outcome

Timeframe: Baseline (Day -2/ Day -1) 16:00h, Day 43 16:00h

Population: Safety population; only non-missing values were analyzed.

Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 16:00h.

Outcome measures

Measure	Rotigotine Patch n=65 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 20 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)	1.58 milliseconds [ms] Standard Deviation 6.07	1.90 milliseconds [ms] Standard Deviation 5.95

PRIMARY outcome

Timeframe: Baseline (Day -2/ Day -1) 17:00h, Day 43 17:00h

Population: Safety population; only non-missing values were analyzed.

Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 17:00h.

Outcome measures

Measure	Rotigotine Patch n=65 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 21 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)	-0.13 milliseconds [ms] Standard Deviation 6.92	0.57 milliseconds [ms] Standard Deviation 6.06

PRIMARY outcome

Timeframe: Baseline (Day -2/ Day -1) 18:00h, Day 43 18:00h

Population: Safety population; only non-missing values were analyzed.

Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 18:00h.

Outcome measures

Measure	Rotigotine Patch n=65 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 22 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)	1.45 milliseconds [ms] Standard Deviation 6.60	0.27 milliseconds [ms] Standard Deviation 6.08

PRIMARY outcome

Timeframe: Baseline (Day -2/ Day -1) 19:00h, Day 43 19:00h

Population: Safety population; only non-missing values were analyzed.

Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 19:00h.

Outcome measures

Measure	Rotigotine Patch n=65 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 23 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)	1.50 milliseconds [ms] Standard Deviation 6.70	0.64 milliseconds [ms] Standard Deviation 6.43

PRIMARY outcome

Timeframe: Baseline (Day -2/ Day -1) 20:00h, Day 43 20:00h

Population: Safety population; only non-missing values were analyzed.

Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 20:00h.

Outcome measures

Measure	Rotigotine Patch n=65 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 24 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)	-0.96 milliseconds [ms] Standard Deviation 7.08	-0.58 milliseconds [ms] Standard Deviation 5.79

SECONDARY outcome

Timeframe: Baseline (Day -2/ Day -1) 8:00h, Day 32/ Day 39 8:00h

Population: Safety population within the placebo patch group; only non-missing values were analyzed.

Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 8:00h.

Outcome measures

Measure	Rotigotine Patch n=61 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=60 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 2 Hours Before Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)	1.70 milliseconds [ms] Standard Deviation 5.76	1.29 milliseconds [ms] Standard Deviation 6.48

SECONDARY outcome

Timeframe: Baseline (Day -2/ Day -1) 9:00h, Day 32/ Day 39 9:00h

Population: Safety population within the placebo patch group; only non-missing values were analyzed.

Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 9:00h.

Outcome measures

Measure	Rotigotine Patch n=61 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 1 Hour Before Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)	1.84 milliseconds [ms] Standard Deviation 5.97	1.36 milliseconds [ms] Standard Deviation 6.03

SECONDARY outcome

Timeframe: Baseline (Day -2/ Day -1) 10:00h, Day 32/ Day 39 10:00h

Population: Safety population within the placebo patch group; only non-missing values were analyzed.

Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 10:00h.

Outcome measures

Measure	Rotigotine Patch n=61 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=60 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI at Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)	2.21 milliseconds [ms] Standard Deviation 6.19	0.82 milliseconds [ms] Standard Deviation 7.34

SECONDARY outcome

Timeframe: Baseline (Day -2/ Day -1) 11:00h, Day 32/ Day 39 11:00h

Population: Safety population within the placebo patch group; only non-missing values were analyzed.

Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 11:00h.

Outcome measures

Measure	Rotigotine Patch n=61 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 1 Hour After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)	17.19 milliseconds [ms] Standard Deviation 7.49	3.70 milliseconds [ms] Standard Deviation 5.72

SECONDARY outcome

Timeframe: Baseline (Day -2/ Day -1) 12:00h, Day 32/ Day 39 12:00h

Population: Safety population within the placebo patch group; only non-missing values were analyzed.

Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 12:00h.

Outcome measures

Measure	Rotigotine Patch n=61 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 2 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)	12.44 milliseconds [ms] Standard Deviation 7.94	1.42 milliseconds [ms] Standard Deviation 6.08

SECONDARY outcome

Timeframe: Baseline (Day -2/ Day -1) 13:00h, Day 32/ Day 39 13:00h

Population: Safety population within the placebo patch group; only non-missing values were analyzed.

Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 13:00h.

Outcome measures

Measure	Rotigotine Patch n=60 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 3 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)	12.68 milliseconds [ms] Standard Deviation 7.35	1.44 milliseconds [ms] Standard Deviation 5.91

SECONDARY outcome

Timeframe: Baseline (Day -2/ Day -1) 14:00h, Day 32/ Day 39 14:00h

Population: Safety population within the placebo patch group; only non-missing values were analyzed.

Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 14:00h.

Outcome measures

Measure	Rotigotine Patch n=61 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=60 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 4 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)	9.48 milliseconds [ms] Standard Deviation 6.95	1.28 milliseconds [ms] Standard Deviation 6.37

SECONDARY outcome

Timeframe: Baseline (Day -2/ Day -1) 15:00h, Day 32/ Day 39 15:00h

Population: Safety population within the placebo patch group; only non-missing values were analyzed.

Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 15:00h.

Outcome measures

Measure	Rotigotine Patch n=61 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=60 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 5 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)	10.06 milliseconds [ms] Standard Deviation 6.53	0.08 milliseconds [ms] Standard Deviation 5.50

SECONDARY outcome

Timeframe: Baseline (Day -2/ Day -1) 16:00h, Day 32/ Day 39 16:00h

Population: Safety population within the placebo patch group; only non-missing values were analyzed.

Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 16:00h.

Outcome measures

Measure	Rotigotine Patch n=61 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 6 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)	9.98 milliseconds [ms] Standard Deviation 6.74	1.10 milliseconds [ms] Standard Deviation 4.93

SECONDARY outcome

Timeframe: Baseline (Day -2/ Day -1) 17:00h, Day 32/ Day 39 17:00h

Population: Safety population within the placebo patch group; only non-missing values were analyzed.

Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 17:00h.

Outcome measures

Measure	Rotigotine Patch n=61 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 7 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)	8.97 milliseconds [ms] Standard Deviation 6.47	0.37 milliseconds [ms] Standard Deviation 6.14

SECONDARY outcome

Timeframe: Baseline (Day -2/ Day -1) 18:00h, Day 32/ Day 39 18:00h

Population: Safety population within the placebo patch group; only non-missing values were analyzed.

Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 18:00h.

Outcome measures

Measure	Rotigotine Patch n=61 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 8 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)	7.74 milliseconds [ms] Standard Deviation 5.84	0.22 milliseconds [ms] Standard Deviation 5.14

SECONDARY outcome

Timeframe: Baseline (Day -2/ Day -1) 19:00h, Day 32/ Day 39 19:00h

Population: Safety population within the placebo patch group; only non-missing values were analyzed.

Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 19:00h.

Outcome measures

Measure	Rotigotine Patch n=61 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 9 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)	7.33 milliseconds [ms] Standard Deviation 6.26	-0.25 milliseconds [ms] Standard Deviation 5.51

SECONDARY outcome

Timeframe: Baseline (Day -2/ Day -1) 20:00h, Day 32/ Day 39 20:00h

Population: Safety population within the placebo patch group; only non-missing values were analyzed.

Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 20:00h.

Outcome measures

Measure	Rotigotine Patch n=61 Participants Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=61 Participants Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 10 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)	6.34 milliseconds [ms] Standard Deviation 6.13	0.14 milliseconds [ms] Standard Deviation 4.98

Adverse Events

Rotigotine Patch

Serious events: 0 serious events

Other events: 63 other events

Deaths: 0 deaths

Placebo Patch

Serious events: 1 serious events

Other events: 54 other events

Deaths: 0 deaths

Serious adverse events

Measure	Rotigotine Patch n=66 participants at risk Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=64 participants at risk Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Nervous system disorders Syncope	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.

Other adverse events

Measure	Rotigotine Patch n=66 participants at risk Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.	Placebo Patch n=64 participants at risk Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
Blood and lymphatic system disorders Neutropenia	3.0% 2/66 • Number of events 2 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Ear and labyrinth disorders Meniere's Disease	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Ear and labyrinth disorders Vertigo	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Eye disorders Conjunctivitis	3.0% 2/66 • Number of events 2 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Eye disorders Vision Blurred	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Eye disorders Visual Disturbance	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Gastrointestinal disorders Toothache	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Gastrointestinal disorders Diarrhoea	9.1% 6/66 • Number of events 6 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	9.4% 6/64 • Number of events 6 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Gastrointestinal disorders Dyspepsia	6.1% 4/66 • Number of events 4 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Gastrointestinal disorders Flatulence	3.0% 2/66 • Number of events 2 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Gastrointestinal disorders Abdominal Pain	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	3.1% 2/64 • Number of events 2 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Gastrointestinal disorders Abdominal Pain Upper	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Gastrointestinal disorders Constipation	7.6% 5/66 • Number of events 6 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Gastrointestinal disorders Nausea	42.4% 28/66 • Number of events 71 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	21.9% 14/64 • Number of events 16 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Gastrointestinal disorders Vomiting	22.7% 15/66 • Number of events 26 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	4.7% 3/64 • Number of events 4 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Gastrointestinal disorders Lip Dry	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Gastrointestinal disorders Lip Swelling	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Gastrointestinal disorders Aphthous Stomatitis	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
General disorders Application Site Irritation	4.5% 3/66 • Number of events 3 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
General disorders Application Site Oedema	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
General disorders Application Site Pruritus	9.1% 6/66 • Number of events 7 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	3.1% 2/64 • Number of events 2 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
General disorders Application Site Reaction	4.5% 3/66 • Number of events 3 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
General disorders Asthenia	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	3.1% 2/64 • Number of events 2 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
General disorders Fatigue	3.0% 2/66 • Number of events 2 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
General disorders Malaise	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	4.7% 3/64 • Number of events 5 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
General disorders Infusion Related Reaction	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
General disorders Infusion Site Pruritus	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
General disorders Infusion Site Reaction	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
General disorders Injection Site Thrombosis	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
General disorders Chest Pain	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Infections and infestations Gastroenteritis	6.1% 4/66 • Number of events 4 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	3.1% 2/64 • Number of events 3 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Infections and infestations Cellulitis	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Infections and infestations Folliculitis	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Infections and infestations Tooth Abscess	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Infections and infestations Herpes Simplex	3.0% 2/66 • Number of events 2 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	3.1% 2/64 • Number of events 2 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Infections and infestations Influenza	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	3.1% 2/64 • Number of events 2 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Infections and infestations Bronchitis	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	3.1% 2/64 • Number of events 2 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Infections and infestations Tinea Cruris	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Infections and infestations Nasopharyngitis	10.6% 7/66 • Number of events 7 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Infections and infestations Pharyngitis	3.0% 2/66 • Number of events 2 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Infections and infestations Sinusitis	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Infections and infestations Upper Respiratory Tract Infection	3.0% 2/66 • Number of events 2 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	3.1% 2/64 • Number of events 2 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Infections and infestations Urinary Tract Infection	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Infections and infestations Viral Infection	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Injury, poisoning and procedural complications Failure Of Implant	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Injury, poisoning and procedural complications Medical Device Site Reaction	22.7% 15/66 • Number of events 17 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	21.9% 14/64 • Number of events 16 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Injury, poisoning and procedural complications Joint Sprain	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Injury, poisoning and procedural complications Limb Injury	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Injury, poisoning and procedural complications Arthropod Bite	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Injury, poisoning and procedural complications Excoriation	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Injury, poisoning and procedural complications Soft Tissue Injury	4.5% 3/66 • Number of events 3 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	3.1% 2/64 • Number of events 2 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Injury, poisoning and procedural complications Traumatic Haematoma	1.5% 1/66 • Number of events 2 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Injury, poisoning and procedural complications Tooth Fracture	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Injury, poisoning and procedural complications Nail Avulsion	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Injury, poisoning and procedural complications Skin Laceration	3.0% 2/66 • Number of events 2 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Investigations Blood Glucose Increased	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Investigations Alanine Aminotransferase Increased	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Investigations Blood Potassium Increased	3.0% 2/66 • Number of events 2 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Investigations Serum Ferritin Decreased	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Investigations Serum Ferritin Increased	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Metabolism and nutrition disorders Anorexia	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Metabolism and nutrition disorders Hyperuricaemia	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Metabolism and nutrition disorders Hyponatraemia	3.0% 2/66 • Number of events 2 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Musculoskeletal and connective tissue disorders Arthralgia	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Musculoskeletal and connective tissue disorders Plantar Fasciitis	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Musculoskeletal and connective tissue disorders Myalgia	3.0% 2/66 • Number of events 2 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	4.7% 3/64 • Number of events 3 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Musculoskeletal and connective tissue disorders Muscle Spasms	6.1% 4/66 • Number of events 5 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	3.1% 2/64 • Number of events 3 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Musculoskeletal and connective tissue disorders Buttock Pain	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Musculoskeletal and connective tissue disorders Pain In Extremity	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 2 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Nervous system disorders Balance Disorder	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Nervous system disorders Somnolence	4.5% 3/66 • Number of events 3 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Nervous system disorders Syncope Vasovagal	3.0% 2/66 • Number of events 2 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Nervous system disorders Dyskinesia	7.6% 5/66 • Number of events 7 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	3.1% 2/64 • Number of events 3 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Nervous system disorders Headache	28.8% 19/66 • Number of events 30 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	25.0% 16/64 • Number of events 27 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Nervous system disorders Tension Headache	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Nervous system disorders Hypertonia	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Nervous system disorders Dizziness	28.8% 19/66 • Number of events 29 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	9.4% 6/64 • Number of events 6 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Nervous system disorders Paraesthesia	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	3.1% 2/64 • Number of events 2 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Nervous system disorders Parkinson's Disease	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	3.1% 2/64 • Number of events 2 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Nervous system disorders Dysgeusia	3.0% 2/66 • Number of events 2 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	3.1% 2/64 • Number of events 3 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Nervous system disorders Tremor	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Psychiatric disorders Anxiety	3.0% 2/66 • Number of events 3 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Psychiatric disorders Disorientation	3.0% 2/66 • Number of events 4 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Psychiatric disorders Depression	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Psychiatric disorders Insomnia	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	4.7% 3/64 • Number of events 3 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Psychiatric disorders Panic Attack	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Psychiatric disorders Abnormal Dreams	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Psychiatric disorders Nightmare	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Psychiatric disorders Hallucination	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Psychiatric disorders Psychotic Disorder	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Psychiatric disorders Bruxism	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Renal and urinary disorders Pollakiuria	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	3.1% 2/64 • Number of events 2 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Renal and urinary disorders Nephrolithiasis	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Renal and urinary disorders Polyuria	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Respiratory, thoracic and mediastinal disorders Cough	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Respiratory, thoracic and mediastinal disorders Hiccups	4.5% 3/66 • Number of events 3 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal Pain	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Respiratory, thoracic and mediastinal disorders Postnasal Drip	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Skin and subcutaneous tissue disorders Hyperhidrosis	3.0% 2/66 • Number of events 2 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Skin and subcutaneous tissue disorders Dermatitis Contact	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Skin and subcutaneous tissue disorders Rash	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Surgical and medical procedures Tooth Extraction	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Vascular disorders Haematoma	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Vascular disorders Thrombophlebitis	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Vascular disorders Varicose Vein	1.5% 1/66 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Vascular disorders Hypotension	0.00% 0/66 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	1.6% 1/64 • Number of events 1 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.
Vascular disorders Orthostatic Hypotension	7.6% 5/66 • Number of events 6 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.	0.00% 0/64 • Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.

Additional Information

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