Trial Outcomes & Findings for Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease (PD) (NCT NCT00434304)

Last Updated: 2018-09-27

Results Overview

The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. Cmax: maximum concentration, Cmin: trough plasma concentration.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

62 participants

Primary outcome timeframe

Weeks 5-16

Results posted on

2018-09-27

Participant Flow

Participant milestones

Participant milestones
Measure	Ropinirole PR/XR Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Overall Study STARTED	62
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Ropinirole PR/XR Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Overall Study Adverse Event	14
Overall Study Lack of Efficacy	2
Overall Study Withdrawal by Subject	4

Baseline Characteristics

Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease (PD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ropinirole PR/XR n=62 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Age, Continuous	67.2 years STANDARD_DEVIATION 8.05 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	62 participants n=5 Participants

PRIMARY outcome

Timeframe: Weeks 5-16

Population: Pharmacokinetic (PK) Population: participants who underwent blood sampling for PK research, excluding those who did not fulfill inclusion criteria and those who were considered to affect the evaluation of the PK research due to drug incompliance or other protocol violation.

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=10 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites SKF101468 (ropinirole), Cmax, fed	1563.784 picograms/milliliter (pg/mL) Interval 1252.648 to 1952.202
Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites SKF101468 (ropinirole), Cmax, fasted	1542.182 picograms/milliliter (pg/mL) Interval 1177.843 to 2019.221
Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites SKF101468 (ropinirole), Cmin, fed	728.404 picograms/milliliter (pg/mL) Interval 565.589 to 938.087
Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites SKF101468 (ropinirole), Cmin, fasted	725.103 picograms/milliliter (pg/mL) Interval 546.75 to 961.636
Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites SKF104557 (metabolite), Cmax, fed	1159.120 picograms/milliliter (pg/mL) Interval 1034.646 to 1298.569
Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites SKF104557 (metabolite), Cmax, fasted	1250.554 picograms/milliliter (pg/mL) Interval 1077.255 to 1451.731
Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites SKF104557 (metabolite), Cmin, fed	798.871 picograms/milliliter (pg/mL) Interval 693.49 to 920.266
Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites SKF104557 (metabolite), Cmin, fasted	786.097 picograms/milliliter (pg/mL) Interval 672.811 to 918.458
Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites SKF89124 (metabolite), Cmax, fed	55.282 picograms/milliliter (pg/mL) Interval 46.462 to 65.776
Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites SKF89124 (metabolite), Cmax, fasted	60.742 picograms/milliliter (pg/mL) Interval 48.303 to 76.384
Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites SKF89124 (metabolite), Cmin, fed	34.281 picograms/milliliter (pg/mL) Interval 27.811 to 42.256
Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites SKF89124 (metabolite), Cmin, fasted	34.599 picograms/milliliter (pg/mL) Interval 28.72 to 41.682

PRIMARY outcome

Timeframe: Weeks 5-16

Population: PK Population

The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours (hr) post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. AUC0-24: area under the drug concentration 24 hr curve.

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=10 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Food Effects on AUC0-24 of SKF101468 (Ropinirole) and Its Metabolites SKF101468 (ropinirole), fed	27206.103 hours*pg/mL Interval 21908.9 to 33784.08
Food Effects on AUC0-24 of SKF101468 (Ropinirole) and Its Metabolites SKF101468 (ropinirole), fasted	27191.804 hours*pg/mL Interval 20738.729 to 35652.821
Food Effects on AUC0-24 of SKF101468 (Ropinirole) and Its Metabolites SKF104557 (metabolite), fed	23090.150 hours*pg/mL Interval 20629.318 to 25844.53
Food Effects on AUC0-24 of SKF101468 (Ropinirole) and Its Metabolites SKF104557 (metabolite), fasted	24478.797 hours*pg/mL Interval 21280.201 to 28158.169
Food Effects on AUC0-24 of SKF101468 (Ropinirole) and Its Metabolites SKF89124 (metabolite), fed	1044.877 hours*pg/mL Interval 882.879 to 1236.601
Food Effects on AUC0-24 of SKF101468 (Ropinirole) and Its Metabolites SKF89124 (metabolite), fasted	1092.635 hours*pg/mL Interval 888.375 to 1343.86

PRIMARY outcome

Timeframe: Weeks 5-16

Population: PK Population

The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. Tmax: time of maximum concentration. Data are presented as the median difference between fed and fasted states for ropinirole and each metabolite.

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=10 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Food Effects on Tmax of SKF101468 (Ropinirole) and Its Metabolites SKF101468 (ropinirole)	2.000 hours Interval -0.1 to 5.0
Food Effects on Tmax of SKF101468 (Ropinirole) and Its Metabolites SKF104557 (metabolite)	3.983 hours Interval 2.0 to 6.0
Food Effects on Tmax of SKF101468 (Ropinirole) and Its Metabolites SKF89124 (metabolite)	1.000 hours Interval -0.1 to 5.0

PRIMARY outcome

Timeframe: Weeks 1-16

Population: PK Population. Blood sampling was performed in all participants in the Fixed titration phase and Maintenance dose phase to measure trough concentration. The maintenance dose differs for individual participants.

Blood sampling in the fixed titration phase will be performed at 24 hour post dose of the last dose of 2, 4, and 8 mg (immediately before the morning dose). Blood sampling in the maintenance dose phase will be performed at 24 hour post dose of 10 mg or more for one week or longer (immediately before the morning dose), as sampling needs to be conducted at steady state.

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=61 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites SKF101468 (ropinirole), 2 mg, n=61	1804.87 pg/mL Standard Deviation 1757.062
Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites SKF101468 (ropinirole), 4 mg, n=58	3529.59 pg/mL Standard Deviation 1746.855
Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites SKF101468 (ropinirole), 6 mg, n=1	3820.20 pg/mL Standard Deviation 0.000
Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites SKF101468 (ropinirole), 8 mg, n=61	7598.90 pg/mL Standard Deviation 5512.105
Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites SKF101468 (ropinirole), 10 mg, n=17	9772.23 pg/mL Standard Deviation 3237.589
Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites SKF101468 (ropinirole), 12 mg, n=12	11971.49 pg/mL Standard Deviation 7211.987
Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites SKF101468 (ropinirole), 14 mg, n=9	12575.41 pg/mL Standard Deviation 5586.121
Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites SKF101468 (ropinirole), 16 mg, n=12	15467.01 pg/mL Standard Deviation 8292.375
Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites SKF104557 (metabolite), 2 mg, n=61	1564.52 pg/mL Standard Deviation 777.387
Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites SKF104557 (metabolite), 4 mg, n=58	3224.53 pg/mL Standard Deviation 1184.861
Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites SKF104557 (metabolite), 6 mg, n=1	4172.10 pg/mL Standard Deviation 0.000
Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites SKF104557 (metabolite), 8 mg, n=61	6353.30 pg/mL Standard Deviation 2173.457
Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites SKF104557 (metabolite), 10 mg, n=17	7944.70 pg/mL Standard Deviation 1887.958
Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites SKF104557 (metabolite), 12 mg, n=12	11814.28 pg/mL Standard Deviation 3917.886
Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites SKF104557 (metabolite), 14 mg, n=9	11579.79 pg/mL Standard Deviation 4279.464
Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites SKF104557 (metabolite), 16 mg, n=12	12753.83 pg/mL Standard Deviation 2527.639
Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites SKF89124 (metabolite), 2 mg, n=61	66.14 pg/mL Standard Deviation 39.824
Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites SKF89124 (metabolite), 4 mg, n=58	139.84 pg/mL Standard Deviation 56.099
Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites SKF89124 (metabolite), 6 mg, n=1	157.40 pg/mL Standard Deviation 0.000
Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites SKF89124 (metabolite), 8 mg, n=61	281.36 pg/mL Standard Deviation 120.381
Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites SKF89124 (metabolite), 10 mg, n=17	318.82 pg/mL Standard Deviation 83.774
Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites SKF89124 (metabolite), 12 mg, n=12	479.36 pg/mL Standard Deviation 189.388
Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites SKF89124 (metabolite), 14 mg, n=9	564.57 pg/mL Standard Deviation 286.257
Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites SKF89124 (metabolite), 16 mg, n=12	628.76 pg/mL Standard Deviation 271.495

SECONDARY outcome

Timeframe: Weeks 0-52

Population: Full Analysis Set (FAS): all participants who progressed to the treatment phase, excluding those who did not fulfill major registration criteria, those who had not received at least one dose of the investigational drug, and those whose measured data were not available after treatment initiation. Participants dropped out of the study each week.

The Unified Parkinson's Disease Rating Scale (UPDRS) assesses the status of Parkinson's Disease (PD) patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=62 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Total Score in the Japanese UPDRS Part III Week 0, n=62	22.4 points on a scale Standard Deviation 10.11
Total Score in the Japanese UPDRS Part III Week 1, n=62	19.3 points on a scale Standard Deviation 9.38
Total Score in the Japanese UPDRS Part III Week 2, n=60	16.8 points on a scale Standard Deviation 8.89
Total Score in the Japanese UPDRS Part III Week 3, n=60	14.5 points on a scale Standard Deviation 8.57
Total Score in the Japanese UPDRS Part III Week 4, n=58	13.0 points on a scale Standard Deviation 8.60
Total Score in the Japanese UPDRS Part III Week 6, n=57	12.1 points on a scale Standard Deviation 8.47
Total Score in the Japanese UPDRS Part III Week 8, n=56	11.1 points on a scale Standard Deviation 7.87
Total Score in the Japanese UPDRS Part III Week 10, n=57	10.2 points on a scale Standard Deviation 7.84
Total Score in the Japanese UPDRS Part III Week 12, n=56	10.1 points on a scale Standard Deviation 7.18
Total Score in the Japanese UPDRS Part III Week 16, n=54	10.3 points on a scale Standard Deviation 6.98
Total Score in the Japanese UPDRS Part III Final Assessment Point (Up to Week 16), n=62	11.1 points on a scale Standard Deviation 7.52
Total Score in the Japanese UPDRS Part III Week 20, n=53	10.4 points on a scale Standard Deviation 7.20
Total Score in the Japanese UPDRS Part III Week 24, n=51	10.6 points on a scale Standard Deviation 7.47
Total Score in the Japanese UPDRS Part III Week 28, n=48	10.6 points on a scale Standard Deviation 7.69
Total Score in the Japanese UPDRS Part III Week 32, n=47	10.7 points on a scale Standard Deviation 7.68
Total Score in the Japanese UPDRS Part III Week 36, n=47	10.7 points on a scale Standard Deviation 7.35
Total Score in the Japanese UPDRS Part III Week 40, n=45	11.0 points on a scale Standard Deviation 8.04
Total Score in the Japanese UPDRS Part III Week 44, n=45	11.3 points on a scale Standard Deviation 9.30
Total Score in the Japanese UPDRS Part III Week 48, n=44	10.2 points on a scale Standard Deviation 7.52
Total Score in the Japanese UPDRS Part III Week 52, n=44	10.7 points on a scale Standard Deviation 7.73

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 1-52

Population: FAS. Participants dropped out of the study each week.

The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=62 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Change From Baseline in the Japanese UPDRS Part III Week 1, n=62	-3.1 points on a scale Standard Deviation 4.21
Change From Baseline in the Japanese UPDRS Part III Week 2, n=60	-5.8 points on a scale Standard Deviation 5.18
Change From Baseline in the Japanese UPDRS Part III Week 3, n=60	-7.7 points on a scale Standard Deviation 6.67
Change From Baseline in the Japanese UPDRS Part III Week 4, n=58	-9.7 points on a scale Standard Deviation 6.77
Change From Baseline in the Japanese UPDRS Part III Week 6, n=57	-10.5 points on a scale Standard Deviation 7.31
Change From Baseline in the Japanese UPDRS Part III Week 8, n=56	-11.5 points on a scale Standard Deviation 7.95
Change From Baseline in the Japanese UPDRS Part III Week 10, n=57	-12.4 points on a scale Standard Deviation 7.57
Change From Baseline in the Japanese UPDRS Part III Week 12, n=56	-12.3 points on a scale Standard Deviation 7.47
Change From Baseline in the Japanese UPDRS Part III Week 16, n=54	-12.2 points on a scale Standard Deviation 8.10
Change From Baseline in the Japanese UPDRS Part III Final Assessment Point (Up to Week 16), n=62	-11.3 points on a scale Standard Deviation 8.21
Change From Baseline in the Japanese UPDRS Part III Week 20, n=53	-12.1 points on a scale Standard Deviation 8.65
Change From Baseline in the Japanese UPDRS Part III Week 24, n=51	-11.6 points on a scale Standard Deviation 8.21
Change From Baseline in the Japanese UPDRS Part III Week 28, n=48	-11.5 points on a scale Standard Deviation 9.04
Change From Baseline in the Japanese UPDRS Part III Week 32, n=47	-11.7 points on a scale Standard Deviation 8.27
Change From Baseline in the Japanese UPDRS Part III Week 36, n=47	-11.7 points on a scale Standard Deviation 8.37
Change From Baseline in the Japanese UPDRS Part III Week 40, n=45	-11.5 points on a scale Standard Deviation 8.26
Change From Baseline in the Japanese UPDRS Part III Week 44, n=45	-11.2 points on a scale Standard Deviation 9.12
Change From Baseline in the Japanese UPDRS Part III Week 48, n=44	-11.9 points on a scale Standard Deviation 8.57
Change From Baseline in the Japanese UPDRS Part III Week 52, n=44	-11.4 points on a scale Standard Deviation 8.55

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 1-52

Population: FAS. Participants dropped out of the study each week.

The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. A maximum total score is 108 points.The higher score indicates more severe PD symptoms.

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=62 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Percent Change From Baseline in the Japanese UPDRS Part III Week 1, n=62	-14.14 percent change Standard Deviation 17.734
Percent Change From Baseline in the Japanese UPDRS Part III Week 2, n=60	-27.14 percent change Standard Deviation 23.525
Percent Change From Baseline in the Japanese UPDRS Part III Week 3, n=60	-35.13 percent change Standard Deviation 28.125
Percent Change From Baseline in the Japanese UPDRS Part III Week 4, n=58	-45.03 percent change Standard Deviation 24.055
Percent Change From Baseline in the Japanese UPDRS Part III Week 6, n=57	-48.35 percent change Standard Deviation 26.605
Percent Change From Baseline in the Japanese UPDRS Part III Week 8, n=56	-51.34 percent change Standard Deviation 30.203
Percent Change From Baseline in the Japanese UPDRS Part III Week 10, n=57	-56.63 percent change Standard Deviation 26.249
Percent Change From Baseline in the Japanese UPDRS Part III Week 12, n=56	-56.24 percent change Standard Deviation 23.382
Percent Change From Baseline in the Japanese UPDRS Part III Week 16, n=54	-53.78 percent change Standard Deviation 28.309
Percent Change From Baseline in the Japanese UPDRS Part III Final Assessment Point (Up to Week 16), n=62	-49.38 percent change Standard Deviation 32.041
Percent Change From Baseline in the Japanese UPDRS Part III Week 20, n=53	-52.61 percent change Standard Deviation 32.017
Percent Change From Baseline in the Japanese UPDRS Part III Week 24, n=51	-51.56 percent change Standard Deviation 28.676
Percent Change From Baseline in the Japanese UPDRS Part III Week 28, n=48	-50.25 percent change Standard Deviation 30.813
Percent Change From Baseline in the Japanese UPDRS Part III Week 32, n=47	-51.67 percent change Standard Deviation 26.037
Percent Change From Baseline in the Japanese UPDRS Part III Week 36, n=47	-51.36 percent change Standard Deviation 27.300
Percent Change From Baseline in the Japanese UPDRS Part III Week 40, n=45	-50.58 percent change Standard Deviation 25.887
Percent Change From Baseline in the Japanese UPDRS Part III Week 44, n=45	-49.51 percent change Standard Deviation 32.903
Percent Change From Baseline in the Japanese UPDRS Part III Week 48, n=44	-53.05 percent change Standard Deviation 28.456
Percent Change From Baseline in the Japanese UPDRS Part III Week 52, n=44	-51.11 percent change Standard Deviation 31.617

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 1-52

Population: FAS. Participants dropped out of the study each week.

A responder is defined as a participant with a 30% or more reduction at baseline. The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=62 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III Week 1, n=62	12.9 percentage of responders
Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III Week 2, n=60	38.3 percentage of responders
Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III Week 3, n=60	58.3 percentage of responders
Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III Week 4, n=58	70.7 percentage of responders
Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III Week 6, n=57	71.9 percentage of responders
Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III Week 8, n=56	82.1 percentage of responders
Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III Week 10, n=57	84.2 percentage of responders
Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III Week 12, n=56	89.3 percentage of responders
Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III Week 16, n=54	81.5 percentage of responders
Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III Final Assessment Point (Up to Week 16), n=62	75.8 percentage of responders
Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III Week 20, n=53	81.1 percentage of responders
Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III Week 24, n=51	78.4 percentage of responders
Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III Week 28, n=48	79.2 percentage of responders
Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III Week 32, n=47	76.6 percentage of responders
Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III Week 36, n=47	76.6 percentage of responders
Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III Week 40, n=45	77.8 percentage of responders
Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III Week 44, n=45	77.8 percentage of responders
Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III Week 48, n=44	81.8 percentage of responders
Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III Week 52, n=44	81.8 percentage of responders

SECONDARY outcome

Timeframe: Weeks 0-52

Population: FAS. Participants dropped out of the study each week.

The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per each item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=62 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Total Score in the Japanese UPDRS Part I Week 0, n=62	1.0 points on a scale Standard Deviation 1.36
Total Score in the Japanese UPDRS Part I Week 1, n=62	0.7 points on a scale Standard Deviation 1.09
Total Score in the Japanese UPDRS Part I Week 2, n=60	0.6 points on a scale Standard Deviation 0.96
Total Score in the Japanese UPDRS Part I Week 3, n=60	0.5 points on a scale Standard Deviation 1.06
Total Score in the Japanese UPDRS Part I Week 4, n=58	0.4 points on a scale Standard Deviation 1.06
Total Score in the Japanese UPDRS Part I Week 6, n=57	0.5 points on a scale Standard Deviation 1.04
Total Score in the Japanese UPDRS Part I Week 8, n=56	0.5 points on a scale Standard Deviation 1.10
Total Score in the Japanese UPDRS Part I Week 10, n=57	0.6 points on a scale Standard Deviation 1.39
Total Score in the Japanese UPDRS Part I Week 12, n=56	0.4 points on a scale Standard Deviation 1.07
Total Score in the Japanese UPDRS Part I Week 16, n=54	0.4 points on a scale Standard Deviation 1.31
Total Score in the Japanese UPDRS Part I Final Assessment Point (Up to Week 16), n=62	0.4 points on a scale Standard Deviation 1.30
Total Score in the Japanese UPDRS Part I Week 20, n=53	0.3 points on a scale Standard Deviation 0.88
Total Score in the Japanese UPDRS Part I Week 24, n=51	0.4 points on a scale Standard Deviation 0.87
Total Score in the Japanese UPDRS Part I Week 28, n=48	0.3 points on a scale Standard Deviation 0.57
Total Score in the Japanese UPDRS Part I Week 32, n=47	0.3 points on a scale Standard Deviation 0.61
Total Score in the Japanese UPDRS Part I Week 36, n=47	0.4 points on a scale Standard Deviation 0.64
Total Score in the Japanese UPDRS Part I Week 40, n=45	0.3 points on a scale Standard Deviation 0.58
Total Score in the Japanese UPDRS Part I Week 44, n=45	0.3 points on a scale Standard Deviation 0.67
Total Score in the Japanese UPDRS Part I Week 48, n=44	0.3 points on a scale Standard Deviation 0.73
Total Score in the Japanese UPDRS Part I Week 52, n=44	0.3 points on a scale Standard Deviation 0.80

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 1-52

Population: FAS. Participants dropped out of the study each week.

The UPDRS (Unified Parkinson's Disease Rating Scale) assesses the status of PD patients objectively. The Japanese UPDRS Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per each item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=62 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Change From Baseline in the Japanese UPDRS Part I Week 1, n=62	-0.3 points on a scale Standard Deviation 1.00
Change From Baseline in the Japanese UPDRS Part I Week 2, n=60	-0.5 points on a scale Standard Deviation 0.91
Change From Baseline in the Japanese UPDRS Part I Week 3, n=60	-0.5 points on a scale Standard Deviation 1.14
Change From Baseline in the Japanese UPDRS Part I Week 4, n=58	-0.5 points on a scale Standard Deviation 1.13
Change From Baseline in the Japanese UPDRS Part I Week 6, n=57	-0.5 points on a scale Standard Deviation 1.21
Change From Baseline in the Japanese UPDRS Part I Week 8, n=56	-0.5 points on a scale Standard Deviation 1.16
Change From Baseline in the Japanese UPDRS Part I Week 10, n=57	-0.3 points on a scale Standard Deviation 1.21
Change From Baseline in the Japanese UPDRS Part I Week 12, n=56	-0.5 points on a scale Standard Deviation 1.14
Change From Baseline in the Japanese UPDRS Part I Week 16, n=54	-0.6 points on a scale Standard Deviation 1.24
Change From Baseline in the Japanese UPDRS Part I Final Assessment Point (Up to Week 16), n=62	-0.5 points on a scale Standard Deviation 1.21
Change From Baseline in the Japanese UPDRS Part I Week 20, n=53	-0.5 points on a scale Standard Deviation 1.15
Change From Baseline in the Japanese UPDRS Part I Week 24, n=51	-0.5 points on a scale Standard Deviation 1.10
Change From Baseline in the Japanese UPDRS Part I Week 28, n=48	-0.5 points on a scale Standard Deviation 1.11
Change From Baseline in the Japanese UPDRS Part I Week 32, n=47	-0.5 points on a scale Standard Deviation 1.20
Change From Baseline in the Japanese UPDRS Part I Week 36, n=47	-0.4 points on a scale Standard Deviation 1.28
Change From Baseline in the Japanese UPDRS Part I Week 40, n=45	-0.4 points on a scale Standard Deviation 1.16
Change From Baseline in the Japanese UPDRS Part I Week 44, n=45	-0.4 points on a scale Standard Deviation 1.25
Change From Baseline in the Japanese UPDRS Part I Week 48, n=44	-0.4 points on a scale Standard Deviation 1.30
Change From Baseline in the Japanese UPDRS Part I Week 52, n=44	-0.4 points on a scale Standard Deviation 1.30

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 1-52

Population: FAS. Participants dropped out of the study each week.

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=62 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Percent Change From Baseline in the Japanese UPDRS Part I Week 1, n=30	-34.17 percent change Standard Deviation 48.460
Percent Change From Baseline in the Japanese UPDRS Part I Week 2, n=29	-54.60 percent change Standard Deviation 46.269
Percent Change From Baseline in the Japanese UPDRS Part I Week 3, n=29	-63.79 percent change Standard Deviation 49.815
Percent Change From Baseline in the Japanese UPDRS Part I Week 4, n=28	-60.71 percent change Standard Deviation 49.735
Percent Change From Baseline in the Japanese UPDRS Part I Week 6, n=27	-69.44 percent change Standard Deviation 48.205
Percent Change From Baseline in the Japanese UPDRS Part I Week 8, n=27	-54.94 percent change Standard Deviation 59.524
Percent Change From Baseline in the Japanese UPDRS Part I Week 10, n=27	-48.46 percent change Standard Deviation 66.105
Percent Change From Baseline in the Japanese UPDRS Part I Week 12, n=26	-62.50 percent change Standard Deviation 67.956
Percent Change From Baseline in the Japanese UPDRS Part I Week 16, n=24	-77.08 percent change Standard Deviation 48.358
Percent Change From Baseline in the Japanese UPDRS Part I Final Assessment Point (Up to Week 16), n=30	-68.89 percent change Standard Deviation 52.838
Percent Change From Baseline in the Japanese UPDRS Part I Week 20, n=23	-71.74 percent change Standard Deviation 51.354
Percent Change From Baseline in the Japanese UPDRS Part I Week 24, n=22	-65.91 percent change Standard Deviation 44.089
Percent Change From Baseline in the Japanese UPDRS Part I Week 28, n=20	-71.67 percent change Standard Deviation 50.466
Percent Change From Baseline in the Japanese UPDRS Part I Week 32, n=19	-67.54 percent change Standard Deviation 71.465
Percent Change From Baseline in the Japanese UPDRS Part I Week 36, n=19	-55.26 percent change Standard Deviation 66.447
Percent Change From Baseline in the Japanese UPDRS Part I Week 40, n=17	-69.61 percent change Standard Deviation 55.664
Percent Change From Baseline in the Japanese UPDRS Part I Week 44, n=17	-52.94 percent change Standard Deviation 69.531
Percent Change From Baseline in the Japanese UPDRS Part I Week 48, n=16	-59.38 percent change Standard Deviation 71.224
Percent Change From Baseline in the Japanese UPDRS Part I Week 52, n=16	-53.13 percent change Standard Deviation 71.807

SECONDARY outcome

Timeframe: Weeks 0-52

Population: FAS. Participants dropped out of the study each week.

The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per each item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=62 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Total Score in the Japanese UPDRS Part II Week 0, n=62	8.2 points on a scale Standard Deviation 4.55
Total Score in the Japanese UPDRS Part II Week 1, n=62	7.2 points on a scale Standard Deviation 4.41
Total Score in the Japanese UPDRS Part II Week 2, n=60	6.3 points on a scale Standard Deviation 4.00
Total Score in the Japanese UPDRS Part II Week 3, n=60	5.5 points on a scale Standard Deviation 3.82
Total Score in the Japanese UPDRS Part II Week 4, n=58	4.8 points on a scale Standard Deviation 3.79
Total Score in the Japanese UPDRS Part II Week 6, n=57	4.5 points on a scale Standard Deviation 3.76
Total Score in the Japanese UPDRS Part II Week 8, n=56	4.0 points on a scale Standard Deviation 3.64
Total Score in the Japanese UPDRS Part II Week 10, n=57	4.1 points on a scale Standard Deviation 3.95
Total Score in the Japanese UPDRS Part II Week 12, n=56	4.2 points on a scale Standard Deviation 3.77
Total Score in the Japanese UPDRS Part II Week 16, n=54	4.1 points on a scale Standard Deviation 3.50
Total Score in the Japanese UPDRS Part II Final Assessment Point (Up to Week 16), n=62	4.3 points on a scale Standard Deviation 3.69
Total Score in the Japanese UPDRS Part II Week 20, n=53	4.1 points on a scale Standard Deviation 3.57
Total Score in the Japanese UPDRS Part II Week 24, n=51	3.7 points on a scale Standard Deviation 3.38
Total Score in the Japanese UPDRS Part II Week 28, n=48	4.0 points on a scale Standard Deviation 3.79
Total Score in the Japanese UPDRS Part II Week 32, n=47	3.9 points on a scale Standard Deviation 3.61
Total Score in the Japanese UPDRS Part II Week 36, n=47	4.0 points on a scale Standard Deviation 3.73
Total Score in the Japanese UPDRS Part II Week 40, n=45	4.1 points on a scale Standard Deviation 3.90
Total Score in the Japanese UPDRS Part II Week 44, n=45	4.2 points on a scale Standard Deviation 4.14
Total Score in the Japanese UPDRS Part II Week 48, n=44	3.8 points on a scale Standard Deviation 3.88
Total Score in the Japanese UPDRS Part II Week 52, n=44	4.1 points on a scale Standard Deviation 4.13

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 1-52

Population: FAS. Participants dropped out of the study each week.

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=62 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Change From Baseline in the Japanese UPDRS Part II Week 1, n=62	-1.0 points on a scale Standard Deviation 1.60
Change From Baseline in the Japanese UPDRS Part II Week 2, n=60	-1.9 points on a scale Standard Deviation 2.14
Change From Baseline in the Japanese UPDRS Part II Week 3, n=60	-2.6 points on a scale Standard Deviation 2.44
Change From Baseline in the Japanese UPDRS Part II Week 4, n=58	-3.4 points on a scale Standard Deviation 2.84
Change From Baseline in the Japanese UPDRS Part II Week 6, n=57	-3.7 points on a scale Standard Deviation 2.74
Change From Baseline in the Japanese UPDRS Part II Week 8, n=56	-4.2 points on a scale Standard Deviation 3.09
Change From Baseline in the Japanese UPDRS Part II Week 10, n=57	-4.1 points on a scale Standard Deviation 3.16
Change From Baseline in the Japanese UPDRS Part II Week 12, n=56	-4.0 points on a scale Standard Deviation 3.20
Change From Baseline in the Japanese UPDRS Part II Week 16, n=54	-4.1 points on a scale Standard Deviation 3.28
Change From Baseline in the Japanese UPDRS Part II Final Assessment Point (Up to Week 16), n=62	-3.9 points on a scale Standard Deviation 3.22
Change From Baseline in the Japanese UPDRS Part II Week 20, n=53	-4.1 points on a scale Standard Deviation 3.50
Change From Baseline in the Japanese UPDRS Part II Week 24, n=51	-4.4 points on a scale Standard Deviation 3.48
Change From Baseline in the Japanese UPDRS Part II Week 28, n=48	-4.0 points on a scale Standard Deviation 3.75
Change From Baseline in the Japanese UPDRS Part II Week 32, n=47	-4.2 points on a scale Standard Deviation 3.66
Change From Baseline in the Japanese UPDRS Part II Week 36, n=47	-4.1 points on a scale Standard Deviation 3.80
Change From Baseline in the Japanese UPDRS Part II Week 40, n=45	-3.9 points on a scale Standard Deviation 3.98
Change From Baseline in the Japanese UPDRS Part II Week 44, n=45	-3.8 points on a scale Standard Deviation 3.84
Change From Baseline in the Japanese UPDRS Part II Week 48, n=44	-4.0 points on a scale Standard Deviation 3.96
Change From Baseline in the Japanese UPDRS Part II Week 52, n=44	-3.7 points on a scale Standard Deviation 4.42

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 1-52

Population: FAS. Participants dropped out of the study each week.

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=62 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Percent Change From Baseline in the Japanese UPDRS Part II Week 1, n=60	-11.01 percent change Standard Deviation 20.504
Percent Change From Baseline in the Japanese UPDRS Part II Week 2, n=58	-23.04 percent change Standard Deviation 26.252
Percent Change From Baseline in the Japanese UPDRS Part II Week 3, n=58	-33.09 percent change Standard Deviation 26.531
Percent Change From Baseline in the Japanese UPDRS Part II Week 4, n=56	-44.30 percent change Standard Deviation 28.348
Percent Change From Baseline in the Japanese UPDRS Part II Week 6, n=55	-48.89 percent change Standard Deviation 28.058
Percent Change From Baseline in the Japanese UPDRS Part II Week 8, n=54	-53.88 percent change Standard Deviation 29.274
Percent Change From Baseline in the Japanese UPDRS Part II Week 10, n=55	-52.52 percent change Standard Deviation 35.133
Percent Change From Baseline in the Japanese UPDRS Part II Week 12, n=54	-51.51 percent change Standard Deviation 31.572
Percent Change From Baseline in the Japanese UPDRS Part II Week 16, n=52	-50.78 percent change Standard Deviation 35.826
Percent Change From Baseline in the Japanese UPDRS Part II Final Assessment Point (Up to Week 16), n=60	-49.03 percent change Standard Deviation 35.664
Percent Change From Baseline in the Japanese UPDRS Part II Week 20, n=51	-50.10 percent change Standard Deviation 35.694
Percent Change From Baseline in the Japanese UPDRS Part II Week 24, n=49	-54.29 percent change Standard Deviation 31.096
Percent Change From Baseline in the Japanese UPDRS Part II Week 28, n=46	-51.15 percent change Standard Deviation 35.620
Percent Change From Baseline in the Japanese UPDRS Part II Week 32, n=45	-50.91 percent change Standard Deviation 37.745
Percent Change From Baseline in the Japanese UPDRS Part II Week 36, n=45	-51.05 percent change Standard Deviation 35.493
Percent Change From Baseline in the Japanese UPDRS Part II Week 40, n=43	-48.31 percent change Standard Deviation 41.477
Percent Change From Baseline in the Japanese UPDRS Part II Week 44, n=43	-47.48 percent change Standard Deviation 40.194
Percent Change From Baseline in the Japanese UPDRS Part II Week 48, n=42	-49.28 percent change Standard Deviation 38.285
Percent Change From Baseline in the Japanese UPDRS Part II Week 52, n=42	-41.48 percent change Standard Deviation 48.287

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 0-52

Population: FAS. Participants dropped out of the study each week.

The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per each item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=62 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Total Score in the Japanese UPDRS Part IV Week 0, n=62	0.4 points on a scale Standard Deviation 0.58
Total Score in the Japanese UPDRS Part IV Week 1, n=62	0.6 points on a scale Standard Deviation 0.71
Total Score in the Japanese UPDRS Part IV Week 2, n=60	0.8 points on a scale Standard Deviation 0.82
Total Score in the Japanese UPDRS Part IV Week 3, n=60	0.7 points on a scale Standard Deviation 0.78
Total Score in the Japanese UPDRS Part IV Week 4, n=58	0.7 points on a scale Standard Deviation 0.82
Total Score in the Japanese UPDRS Part IV Week 6, n=57	0.7 points on a scale Standard Deviation 0.78
Total Score in the Japanese UPDRS Part IV Week 8, n=56	0.5 points on a scale Standard Deviation 0.63
Total Score in the Japanese UPDRS Part IV Week 10, n=57	0.5 points on a scale Standard Deviation 0.68
Total Score in the Japanese UPDRS Part IV Week 12, n=56	0.5 points on a scale Standard Deviation 0.66
Total Score in the Japanese UPDRS Part IV Week 16, n=54	0.6 points on a scale Standard Deviation 0.63
Total Score in the Japanese UPDRS Part IV Final Assessment Point (Up to Week 16), n=62	0.6 points on a scale Standard Deviation 0.66
Total Score in the Japanese UPDRS Part IV Week 20, n=53	0.6 points on a scale Standard Deviation 0.71
Total Score in the Japanese UPDRS Part IV Week 24, n=51	0.5 points on a scale Standard Deviation 0.64
Total Score in the Japanese UPDRS Part IV Week 28, n=48	0.6 points on a scale Standard Deviation 0.70
Total Score in the Japanese UPDRS Part IV Week 32, n=47	0.5 points on a scale Standard Deviation 0.62
Total Score in the Japanese UPDRS Part IV Week 36, n=47	0.6 points on a scale Standard Deviation 0.62
Total Score in the Japanese UPDRS Part IV Week 40, n=45	0.4 points on a scale Standard Deviation 0.58
Total Score in the Japanese UPDRS Part IV Week 44, n=45	0.5 points on a scale Standard Deviation 0.59
Total Score in the Japanese UPDRS Part IV Week 48, n=44	0.5 points on a scale Standard Deviation 0.59
Total Score in the Japanese UPDRS Part IV Week 52, n=44	0.5 points on a scale Standard Deviation 0.63

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 1-52

Population: FAS. Participants dropped out of the study each week.

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=62 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Change From Baseline in the Japanese UPDRS Part IV Week 1, n=62	0.2 points on a scale Standard Deviation 0.64
Change From Baseline in the Japanese UPDRS Part IV Week 2, n=60	0.4 points on a scale Standard Deviation 0.74
Change From Baseline in the Japanese UPDRS Part IV Week 3, n=60	0.3 points on a scale Standard Deviation 0.74
Change From Baseline in the Japanese UPDRS Part IV Week 4, n=58	0.3 points on a scale Standard Deviation 0.78
Change From Baseline in the Japanese UPDRS Part IV Week 6, n=57	0.3 points on a scale Standard Deviation 0.83
Change From Baseline in the Japanese UPDRS Part IV Week 8, n=56	0.2 points on a scale Standard Deviation 0.74
Change From Baseline in the Japanese UPDRS Part IV Week 10, n=57	0.2 points on a scale Standard Deviation 0.70
Change From Baseline in the Japanese UPDRS Part IV Week 12, n=56	0.2 points on a scale Standard Deviation 0.72
Change From Baseline in the Japanese UPDRS Part IV Week 16, n=54	0.2 points on a scale Standard Deviation 0.63
Change From Baseline in the Japanese UPDRS Part IV Final Assessment Point (Up to Week 16), n=62	0.2 points on a scale Standard Deviation 0.66
Change From Baseline in the Japanese UPDRS Part IV Week 20, n=53	0.3 points on a scale Standard Deviation 0.67
Change From Baseline in the Japanese UPDRS Part IV Week 24, n=51	0.2 points on a scale Standard Deviation 0.68
Change From Baseline in the Japanese UPDRS Part IV Week 28, n=48	0.3 points on a scale Standard Deviation 0.75
Change From Baseline in the Japanese UPDRS Part IV Week 32, n=47	0.2 points on a scale Standard Deviation 0.70
Change From Baseline in the Japanese UPDRS Part IV Week 36, n=47	0.3 points on a scale Standard Deviation 0.71
Change From Baseline in the Japanese UPDRS Part IV Week 40, n=45	0.1 points on a scale Standard Deviation 0.66
Change From Baseline in the Japanese UPDRS Part IV Week 44, n=45	0.2 points on a scale Standard Deviation 0.63
Change From Baseline in the Japanese UPDRS Part IV Week 48, n=44	0.3 points on a scale Standard Deviation 0.72
Change From Baseline in the Japanese UPDRS Part IV Week 52, n=44	0.2 points on a scale Standard Deviation 0.74

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 1-52

Population: FAS. Participants dropped out of the study each week.

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=62 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Percent Change From Baseline in the Japanese UPDRS Part IV Week 1, n=21	-2.38 percent change Standard Deviation 64.180
Percent Change From Baseline in the Japanese UPDRS Part IV Week 2, n=20	17.50 percent change Standard Deviation 71.221
Percent Change From Baseline in the Japanese UPDRS Part IV Week 3, n=19	10.53 percent change Standard Deviation 79.196
Percent Change From Baseline in the Japanese UPDRS Part IV Week 4, n=19	7.89 percent change Standard Deviation 75.024
Percent Change From Baseline in the Japanese UPDRS Part IV Week 6, n=18	-5.56 percent change Standard Deviation 72.536
Percent Change From Baseline in the Japanese UPDRS Part IV Week 8, n=17	-35.29 percent change Standard Deviation 60.634
Percent Change From Baseline in the Japanese UPDRS Part IV Week 10, n=18	-16.67 percent change Standard Deviation 70.711
Percent Change From Baseline in the Japanese UPDRS Part IV Week 12, n=17	-14.71 percent change Standard Deviation 70.189
Percent Change From Baseline in the Japanese UPDRS Part IV Week 16, n=16	-15.63 percent change Standard Deviation 50.724
Percent Change From Baseline in the Japanese UPDRS Part IV Final Assessment Point (Up to Week 16), n=21	-16.67 percent change Standard Deviation 48.305
Percent Change From Baseline in the Japanese UPDRS Part IV Week 20, n=15	-6.67 percent change Standard Deviation 79.881
Percent Change From Baseline in the Japanese UPDRS Part IV Week 24, n=14	-25.00 percent change Standard Deviation 58.012
Percent Change From Baseline in the Japanese UPDRS Part IV Week 28, n=13	-23.08 percent change Standard Deviation 59.914
Percent Change From Baseline in the Japanese UPDRS Part IV Week 32, n=13	-34.62 percent change Standard Deviation 62.532
Percent Change From Baseline in the Japanese UPDRS Part IV Week 36, n=13	-26.92 percent change Standard Deviation 72.501
Percent Change From Baseline in the Japanese UPDRS Part IV Week 40, n=12	-41.67 percent change Standard Deviation 79.296
Percent Change From Baseline in the Japanese UPDRS Part IV Week 44, n=12	-25.00 percent change Standard Deviation 75.378
Percent Change From Baseline in the Japanese UPDRS Part IV Week 48, n=12	-41.67 percent change Standard Deviation 66.856
Percent Change From Baseline in the Japanese UPDRS Part IV Week 52, n=12	-41.67 percent change Standard Deviation 51.493

SECONDARY outcome

Timeframe: Screening-Week 52

Population: FAS. Participants dropped out of the study each week.

Hoehn \& Yahr criteria were measured on an 8-point scale. 0: No signs of disease, 1: Unilateral disease, 1.5: Unilateral plus axial involvement, 2: Bilateral disease, 2.5: Mild bilateral disease, 3: Mild to moderate bilateral disease. No subjects evaluated had a score of 4 (severe disability) or 5 (wheelchair bound or bedridden unless aided).

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=62 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Summary of the Modified Hoehn & Yahr Criteria Stages Week 0, Stage 1.5	5 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 0, Stage 1	6 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Screening, Stage 0	0 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Screening, Stage 1	7 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Screening, Stage 1.5	7 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Screening, Stage 2	18 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Screening, Stage 2.5	12 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Screening, Stage 3	18 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 0, Stage 0	0 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 0, Stage 2	23 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 0, Stage 2.5	12 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 0, Stage 3	16 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 1, Stage 0	0 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 1, Stage 1	8 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 1, Stage 1.5	4 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 1, Stage 2	24 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 1, Stage 2.5	12 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 1, Stage 3	14 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 2, Stage 0	1 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 2, Stage 1	8 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 2, Stage 1.5	5 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 2, Stage 2	22 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 2, Stage 2.5	12 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 2, Stage 3	12 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 3, Stage 0	0 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 3, Stage 1	12 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 3, Stage 1.5	3 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 3, Stage 2	26 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 3, Stage 2.5	8 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 3, Stage 3	11 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 4, Stage 0	0 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 4, Stage 1	12 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 4, Stage 1.5	5 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 4, Stage 2	26 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 4, Stage 2.5	7 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 4, Stage 3	8 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 6, Stage 0	1 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 6, Stage 1	17 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 6, Stage 1.5	4 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 6, Stage 2	23 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 6, Stage 2.5	3 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 6, Stage 3	9 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 8, Stage 0	1 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 8, Stage 1	18 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 8, Stage 1.5	5 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 8, Stage 2	21 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 8, Stage 2.5	7 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 8, Stage 3	4 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 10, Stage 0	3 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 10, Stage 1	19 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 10, Stage 1.5	7 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 10, Stage 2	21 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 10, Stage 2.5	2 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 10, Stage 3	5 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 12, Stage 0	3 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 12, Stage 1	18 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 12, Stage 1.5	8 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 12, Stage 2	17 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 12, Stage 2.5	5 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 12, Stage 3	5 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 16, Stage 0	3 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 16, Stage 1	16 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 16, Stage 1.5	6 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 16, Stage 2	20 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 16, Stage 2.5	4 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 16, Stage 3	5 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Final Assessment Point (Up to Week 16), Stage 0	3 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Final Assessment Point (Up to Week 16), Stage 1	18 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Final Assessment Point (Up to Week 16), Stage 1.5	6 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Final Assessment Point (Up to Week 16), Stage 2	23 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Final Assessment Point (Up to Week 16), Stage 2.5	5 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Final Assessment Point (Up to Week 16), Stage 3	7 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 20, Stage 0	4 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 20, Stage 1	16 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 20, Stage 1.5	3 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 20, Stage 2	20 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 20, Stage 2.5	3 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 20, Stage 3	7 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 24, Stage 0	3 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 24, Stage 1	14 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 24, Stage 1.5	3 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 24, Stage 2	22 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 24, Stage 2.5	4 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 24, Stage 3	5 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 28, Stage 0	2 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 28, Stage 1	14 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 28, Stage 1.5	4 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 28, Stage 2	17 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 28, Stage 2.5	5 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 28, Stage 3	6 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 32, Stage 0	2 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 32, Stage 1	14 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 32, Stage 1.5	2 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 32, Stage 2	19 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 32, Stage 2.5	5 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 32, Stage 3	5 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 36, Stage 0	2 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 36, Stage 1	13 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 36, Stage 1.5	2 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 36, Stage 2	19 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 36, Stage 2.5	6 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 36, Stage 3	5 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 40, Stage 0	2 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 40, Stage 1	12 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 40, Stage 1.5	2 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 40, Stage 2	18 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 40, Stage 2.5	7 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 40, Stage 3	4 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 44, Stage 0	2 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 44, Stage 1	16 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 44, Stage 1.5	2 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 44, Stage 2	14 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 44, Stage 2.5	5 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 44, Stage 3	6 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 48, Stage 0	1 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 48, Stage 1	16 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 48, Stage 1.5	1 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 48, Stage 2	16 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 48, Stage 2.5	4 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 48, Stage 3	6 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 52, Stage 0	1 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 52, Stage 1	15 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 52, Stage 1.5	2 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 52, Stage 2	16 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 52, Stage 2.5	5 points on a scale
Summary of the Modified Hoehn & Yahr Criteria Stages Week 52, Stage 3	5 points on a scale

SECONDARY outcome

Timeframe: Weeks 1-52

Population: FAS. Participants dropped out of the study each week.

CGI is measured on a 7-point scale. 1: Very much improved, 2: Much Improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse. Responders are defined as those participants scored as "very much improved" or "much improved."

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=62 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale Week 1, n=62	8 participants
Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale Week 2, n=60	16 participants
Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale Week 3, n=60	25 participants
Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale Week 4, n=58	39 participants
Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale Week 6, n=57	40 participants
Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale Week 8, n=56	45 participants
Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale Week 10, n=57	47 participants
Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale Week 12, n=56	48 participants
Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale Week 16, n=54	41 participants
Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale Final Assessment Point (Up to Week 16), n=62	44 participants
Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale Week 20, n=53	43 participants
Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale Week 24, n=51	40 participants
Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale Week 28, n=48	38 participants
Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale Week 32, n=47	35 participants
Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale Week 36, n=47	35 participants
Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale Week 40, n=45	33 participants
Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale Week 44, n=45	35 participants
Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale Week 48, n=44	37 participants
Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale Week 52, n=44	35 participants

SECONDARY outcome

Timeframe: Days 0-364

Population: FAS. Participants dropped out of the study each week.

The percentage of participants remaining in the study was examined using the Kaplan-Meier method, in which a premature discontinuation will be considered as an event.

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=62 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Percentage of Participants Who Remained in the Study on the Indicated Days Day 0	100 percentage of participants
Percentage of Participants Who Remained in the Study on the Indicated Days Day 10	98 percentage of participants
Percentage of Participants Who Remained in the Study on the Indicated Days Day 14	97 percentage of participants
Percentage of Participants Who Remained in the Study on the Indicated Days Day 21	94 percentage of participants
Percentage of Participants Who Remained in the Study on the Indicated Days Day 28	92 percentage of participants
Percentage of Participants Who Remained in the Study on the Indicated Days Day 70	90 percentage of participants
Percentage of Participants Who Remained in the Study on the Indicated Days Day 84	89 percentage of participants
Percentage of Participants Who Remained in the Study on the Indicated Days Day 96	87 percentage of participants
Percentage of Participants Who Remained in the Study on the Indicated Days Day 112	85 percentage of participants
Percentage of Participants Who Remained in the Study on the Indicated Days Day 140	84 percentage of participants
Percentage of Participants Who Remained in the Study on the Indicated Days Day 168	82 percentage of participants
Percentage of Participants Who Remained in the Study on the Indicated Days Day 175	79 percentage of participants
Percentage of Participants Who Remained in the Study on the Indicated Days Day 183	77 percentage of participants
Percentage of Participants Who Remained in the Study on the Indicated Days Day 196	76 percentage of participants
Percentage of Participants Who Remained in the Study on the Indicated Days Day 239	74 percentage of participants
Percentage of Participants Who Remained in the Study on the Indicated Days Day 252	73 percentage of participants
Percentage of Participants Who Remained in the Study on the Indicated Days Day 315	71 percentage of participants
Percentage of Participants Who Remained in the Study on the Indicated Days Day 359	69 percentage of participants
Percentage of Participants Who Remained in the Study on the Indicated Days Day 364	67 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Screening) and Weeks 16 and 52

Population: Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward \[LOCF\]) = 62 participants; Week 52 (Observed case \[OC\]) = 44 participants

Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=62 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Change From Baseline in Albumin, Total Protein, and Hemoglobin at Weeks 16 and 52 Albumin, Week 16	-0.66 grams per Liter (G/L) Standard Deviation 1.983
Change From Baseline in Albumin, Total Protein, and Hemoglobin at Weeks 16 and 52 Albumin, Week 52	-1.68 grams per Liter (G/L) Standard Deviation 2.428
Change From Baseline in Albumin, Total Protein, and Hemoglobin at Weeks 16 and 52 Total Protein, Week 16	-1.71 grams per Liter (G/L) Standard Deviation 3.761
Change From Baseline in Albumin, Total Protein, and Hemoglobin at Weeks 16 and 52 Total Protein, Week 52	-2.32 grams per Liter (G/L) Standard Deviation 3.665
Change From Baseline in Albumin, Total Protein, and Hemoglobin at Weeks 16 and 52 Hemoglobin, Week 16	-4.44 grams per Liter (G/L) Standard Deviation 9.557
Change From Baseline in Albumin, Total Protein, and Hemoglobin at Weeks 16 and 52 Hemoglobin, Week 52	-4.00 grams per Liter (G/L) Standard Deviation 11.477

SECONDARY outcome

Timeframe: Baseline (Screening) and Weeks 16 and 52

Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=62 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52 Alkaline Phosphatase, Week 16	16.5 international units per Liter (IU/L) Standard Deviation 47.25
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52 Alkaline Phosphatase, Week 52	2.5 international units per Liter (IU/L) Standard Deviation 37.78
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52 Alanine Amino Transferase, Week 16	1.1 international units per Liter (IU/L) Standard Deviation 9.34
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52 Alanine Amino Transferase, Week 52	2.3 international units per Liter (IU/L) Standard Deviation 13.34
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52 Aspartate Amino Transferase, Week 16	0.3 international units per Liter (IU/L) Standard Deviation 6.71
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52 Aspartate Amino Transferase, Week 52	2.0 international units per Liter (IU/L) Standard Deviation 9.14
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52 Creatine Kinase, Week 16	5.7 international units per Liter (IU/L) Standard Deviation 117.47
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52 Creatine Kinase, Week 52	44.0 international units per Liter (IU/L) Standard Deviation 142.26
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52 Gamma Glutamyl transferase, Week 16	-0.2 international units per Liter (IU/L) Standard Deviation 21.60
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52 Gamma Glutamyl transferase, Week 52	-3.6 international units per Liter (IU/L) Standard Deviation 28.47
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52 Lactate Dehydrogenase, Week 16	-2.9 international units per Liter (IU/L) Standard Deviation 28.59
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52 Lactate Dehydrogenase, Week 52	8.7 international units per Liter (IU/L) Standard Deviation 34.25

SECONDARY outcome

Timeframe: Baseline (Screening) and Weeks 16 and 52

Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=62 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Change From Baseline in Total Bilirubin, Blood Urea Nitrogen, and Creatinine at Weeks 16 and 52 Total Bilirubin, Week 16	0.19 micromoles per Liter (UMOL/L) Standard Deviation 3.806
Change From Baseline in Total Bilirubin, Blood Urea Nitrogen, and Creatinine at Weeks 16 and 52 Total Bilirubin, Week 52	0.12 micromoles per Liter (UMOL/L) Standard Deviation 2.429
Change From Baseline in Total Bilirubin, Blood Urea Nitrogen, and Creatinine at Weeks 16 and 52 Creatinine, Week 16	2.281 micromoles per Liter (UMOL/L) Standard Deviation 6.780
Change From Baseline in Total Bilirubin, Blood Urea Nitrogen, and Creatinine at Weeks 16 and 52 Creatinine, Week 52	1.266 micromoles per Liter (UMOL/L) Standard Deviation 7.763

SECONDARY outcome

Timeframe: Baseline (Screening) and Weeks 16 and 52

Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=62 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52 Blood Urea Nitrogen, Week 16	0.02 millimoles per Liter (MMOL/L) Standard Deviation 1.448
Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52 Blood Urea Nitrogen, Week 52	0.19 millimoles per Liter (MMOL/L) Standard Deviation 1.512
Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52 Cholesterol, Week 16	-0.3 millimoles per Liter (MMOL/L) Standard Deviation 0.65
Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52 Cholesterol, Week 52	-0.3 millimoles per Liter (MMOL/L) Standard Deviation 0.59
Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52 Chloride, Week 16	-0.1 millimoles per Liter (MMOL/L) Standard Deviation 2.62
Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52 Chloride, Week 52	0.4 millimoles per Liter (MMOL/L) Standard Deviation 2.13
Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52 Potassium, Week 16	-0.01 millimoles per Liter (MMOL/L) Standard Deviation 0.334
Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52 Potassium, Week 52	-0.03 millimoles per Liter (MMOL/L) Standard Deviation 0.378
Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52 Sodium, Week 16	-0.1 millimoles per Liter (MMOL/L) Standard Deviation 2.46
Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52 Sodium, Week 52	-0.1 millimoles per Liter (MMOL/L) Standard Deviation 1.92

SECONDARY outcome

Timeframe: Baseline (Screening) and Weeks 16 and 52

Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=62 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Change From Baseline in Prolactin at Weeks 16 and 52 Week 16	-7.22 micrograms per Liter (MCG/L) Standard Deviation 7.132
Change From Baseline in Prolactin at Weeks 16 and 52 Week 52	-8.18 micrograms per Liter (MCG/L) Standard Deviation 2.495

SECONDARY outcome

Timeframe: Baseline (Screening) and Weeks 16 and 52

Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=62 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Change From Baseline in Hematocrit at Weeks 16 and 52 Week 16	-0.01 proportion of 1 (SI) Standard Deviation 0.028
Change From Baseline in Hematocrit at Weeks 16 and 52 Week 52	-0.01 proportion of 1 (SI) Standard Deviation 0.028

SECONDARY outcome

Timeframe: Baseline (Screening) and Weeks 16 and 52

Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=62 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Change From Baseline in Platelet Count and White Blood Cell Count at Weeks 16 and 52 Platelet count, Week 16	-6.81 giga per Liter (GI/L) Standard Deviation 31.618
Change From Baseline in Platelet Count and White Blood Cell Count at Weeks 16 and 52 Platelet count, Week 52	-8.07 giga per Liter (GI/L) Standard Deviation 44.229
Change From Baseline in Platelet Count and White Blood Cell Count at Weeks 16 and 52 White Blood Cell Count, Week 16	-0.6 giga per Liter (GI/L) Standard Deviation 1.30
Change From Baseline in Platelet Count and White Blood Cell Count at Weeks 16 and 52 White Blood Cell Count, Week 52	-0.5 giga per Liter (GI/L) Standard Deviation 1.10

SECONDARY outcome

Timeframe: Baseline (Screening) and Weeks 16 and 52

Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=62 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Change From Baseline in Red Blood Cell Count at Weeks 16 and 52 Week 16	-0.1 tera per Liter (TI/L) Standard Deviation 0.26
Change From Baseline in Red Blood Cell Count at Weeks 16 and 52 Week 52	-0.2 tera per Liter (TI/L) Standard Deviation 0.27

SECONDARY outcome

Timeframe: Screening, Week 16, and Week 52

Population: Safety Population: Screening Week 16 (LOCF) = 62 participants; Week 52 (OC) = 44 participants

The number of participants with the indicated dipstick test values were measured. Dipstick test values: Neg Value, Trace, +1, +2, +3, +4. No participants had a score of +5.

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=62 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Urinalysis Data Urine Occult Blood - Screening: Neg Value	52 participants
Urinalysis Data Urine Occult Blood - Screening: Trace	7 participants
Urinalysis Data Urine Occult Blood - Screening: +1	1 participants
Urinalysis Data Urine Occult Blood - Screening: +2	1 participants
Urinalysis Data Urine Occult Blood - Screening: +3	1 participants
Urinalysis Data Urine Occult Blood - Screening: +4	0 participants
Urinalysis Data Urine Occult Blood - Week 16: Neg Value	53 participants
Urinalysis Data Urine Occult Blood - Week 16: Trace	4 participants
Urinalysis Data Urine Occult Blood - Week 16: +1	5 participants
Urinalysis Data Urine Occult Blood - Week 16: +2	0 participants
Urinalysis Data Urine Occult Blood - Week 16: +3	0 participants
Urinalysis Data Urine Occult Blood - Week 16: +4	0 participants
Urinalysis Data Urine Occult Blood - Week 52: Neg Value	41 participants
Urinalysis Data Urine Occult Blood - Week 52: Trace	1 participants
Urinalysis Data Urine Occult Blood - Week 52: +1	2 participants
Urinalysis Data Urine Occult Blood - Week 52: +2	0 participants
Urinalysis Data Urine Occult Blood - Week 52: +3	0 participants
Urinalysis Data Urine Occult Blood - Week 52: +4	0 participants
Urinalysis Data Urine Glucose - Screening: Neg Value	57 participants
Urinalysis Data Urine Glucose - Screening: Trace	0 participants
Urinalysis Data Urine Glucose - Screening: +1	1 participants
Urinalysis Data Urine Glucose - Screening: +2	2 participants
Urinalysis Data Urine Glucose - Screening: +3	1 participants
Urinalysis Data Urine Glucose - Screening: +4	1 participants
Urinalysis Data Urine Glucose - Week 16: Neg Value	59 participants
Urinalysis Data Urine Glucose - Week 16: Trace	0 participants
Urinalysis Data Urine Glucose - Week 16: +1	2 participants
Urinalysis Data Urine Glucose - Week 16: +2	0 participants
Urinalysis Data Urine Glucose - Week 16: +3	0 participants
Urinalysis Data Urine Glucose - Week 16: +4	1 participants
Urinalysis Data Urine Glucose - Week 52: Neg Value	41 participants
Urinalysis Data Urine Glucose - Week 52: Trace	2 participants
Urinalysis Data Urine Glucose - Week 52: +1	0 participants
Urinalysis Data Urine Glucose - Week 52: +2	0 participants
Urinalysis Data Urine Glucose - Week 52: +3	0 participants
Urinalysis Data Urine Glucose - Week 52: +4	1 participants
Urinalysis Data Urine Protein - Screening: Neg Value	60 participants
Urinalysis Data Urine Protein - Screening: Trace	0 participants
Urinalysis Data Urine Protein - Screening: +1	2 participants
Urinalysis Data Urine Protein - Screening: +2	0 participants
Urinalysis Data Urine Protein - Screening: +3	0 participants
Urinalysis Data Urine Protein - Screening: +4	0 participants
Urinalysis Data Urine Protein - Week 16: Neg Value	55 participants
Urinalysis Data Urine Protein - Week 16: Trace	3 participants
Urinalysis Data Urine Protein - Week 16: +1	3 participants
Urinalysis Data Urine Protein - Week 16: +2	1 participants
Urinalysis Data Urine Protein - Week 16: +3	0 participants
Urinalysis Data Urine Protein - Week 16: +4	0 participants
Urinalysis Data Urine Protein - Week 52: Neg Value	43 participants
Urinalysis Data Urine Protein - Week 52: Trace	0 participants
Urinalysis Data Urine Protein - Week 52: +1	1 participants
Urinalysis Data Urine Protein - Week 52: +2	0 participants
Urinalysis Data Urine Protein - Week 52: +3	0 participants
Urinalysis Data Urine Protein - Week 52: +4	0 participants
Urinalysis Data Urine Urobilinogen - Screening: Neg Value	0 participants
Urinalysis Data Urine Urobilinogen - Screening: Trace	62 participants
Urinalysis Data Urine Urobilinogen - Screening: +1	0 participants
Urinalysis Data Urine Urobilinogen - Screening: +2	0 participants
Urinalysis Data Urine Urobilinogen - Screening: +3	0 participants
Urinalysis Data Urine Urobilinogen - Screening: +4	0 participants
Urinalysis Data Urine Urobilinogen - Week 16: Neg Value	0 participants
Urinalysis Data Urine Urobilinogen - Week 16: Trace	61 participants
Urinalysis Data Urine Urobilinogen - Week 16: +1	1 participants
Urinalysis Data Urine Urobilinogen - Week 16: +2	0 participants
Urinalysis Data Urine Urobilinogen - Week 16: +3	0 participants
Urinalysis Data Urine Urobilinogen - Week 16: +4	0 participants
Urinalysis Data Urine Urobilinogen - Week 52: Neg Value	0 participants
Urinalysis Data Urine Urobilinogen - Week 52: Trace	43 participants
Urinalysis Data Urine Urobilinogen - Week 52: +1	1 participants
Urinalysis Data Urine Urobilinogen - Week 52: +2	0 participants
Urinalysis Data Urine Urobilinogen - Week 52: +3	0 participants
Urinalysis Data Urine Urobilinogen - Week 52: +4	0 participants

SECONDARY outcome

Timeframe: Baseline (Screening) and Weeks 16 and 52

Population: Safety Population: Week 16 (LOCF) = 62 participants; Week 52 (OC) = 44 participants

Baseline Finding/Time Period Finding. Abbreviations: N = normal; A = abnormal; CS = clinically significant; NCS = not clinically significant. Options include N/N, N/ANCS, N/ACS, ANCS/N, ANCS/ANCS, ANCS/ACS, ACS/N, ACS/ANCS, and ACS/ACS.

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=62 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 Baseline: N; Week 16: N	32 participants
Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 Baseline: N; Week 16: ANCS	10 participants
Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 Baseline: N; Week 16: ACS	0 participants
Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 Baseline: ANCS; Week 16: N	5 participants
Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 Baseline: ANCS; Week 16: ANCS	13 participants
Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 Baseline: ANCS; Week 16: ACS	0 participants
Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 Baseline: ACS; Week 16: N	0 participants
Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 Baseline: ACS; Week 16: ANCS	0 participants
Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 Baseline: ACS; Week 16: ACS	2 participants
Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 Baseline: N; Week 52: N	26 participants
Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 Baseline: N; Week 52: ANCS	3 participants
Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 Baseline: N; Week 52: ACS	0 participants
Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 Baseline: ANCS; Week 52: N	5 participants
Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 Baseline: ANCS; Week 52: ANCS	9 participants
Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 Baseline: ANCS; Week 52: ACS	0 participants
Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 Baseline: ACS; Week 52: N	0 participants
Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 Baseline: ACS; Week 52: ANCS	0 participants
Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 Baseline: ACS; Week 52: ACS	1 participants

SECONDARY outcome

Timeframe: Baseline (Screening) and Weeks 16 and 52

Population: Safety Population: Week 16 (LOCF) = 62 participants; Week 52 (OC) = 44 participants

Change from baseline was calculated as Week 16 and Week 52 values minus baseline values.

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=62 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Change From Baseline in Supine and Standing Systolic and Diastolic Blood Pressure at Weeks 16 and 52 Supine Systolic BP - Week 16	-0.0 millimeters of mercury (mmHg) Standard Deviation 20.54
Change From Baseline in Supine and Standing Systolic and Diastolic Blood Pressure at Weeks 16 and 52 Supine Systolic BP - Week 52	-1.2 millimeters of mercury (mmHg) Standard Deviation 22.84
Change From Baseline in Supine and Standing Systolic and Diastolic Blood Pressure at Weeks 16 and 52 Supine Diastolic BP - Week 16	0.6 millimeters of mercury (mmHg) Standard Deviation 11.57
Change From Baseline in Supine and Standing Systolic and Diastolic Blood Pressure at Weeks 16 and 52 Supine Diastolic BP - Week 52	-1.2 millimeters of mercury (mmHg) Standard Deviation 12.06
Change From Baseline in Supine and Standing Systolic and Diastolic Blood Pressure at Weeks 16 and 52 Standing Systolic BP - Week 16	-0.7 millimeters of mercury (mmHg) Standard Deviation 19.77
Change From Baseline in Supine and Standing Systolic and Diastolic Blood Pressure at Weeks 16 and 52 Standing Systolic BP - Week 52	0.0 millimeters of mercury (mmHg) Standard Deviation 19.08
Change From Baseline in Supine and Standing Systolic and Diastolic Blood Pressure at Weeks 16 and 52 Standing Diastolic BP - Week 16	-0.7 millimeters of mercury (mmHg) Standard Deviation 12.93
Change From Baseline in Supine and Standing Systolic and Diastolic Blood Pressure at Weeks 16 and 52 Standing Diastolic BP - Week 52	2.1 millimeters of mercury (mmHg) Standard Deviation 12.17

SECONDARY outcome

Timeframe: Baseline (Screening) and Weeks 16 and 52

Population: Safety Population: Week 16 (LOCF) = 62 participants; Week 52 (OC) = 44 participants

Change from baseline was calculated as Week 16 and Week 52 values minus baseline values.

Outcome measures

Outcome measures
Measure	Ropinirole PR/XR n=62 Participants Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Change From Baseline in Supine and Standing Pulse Rate at Weeks 16 and 52 Supine Heart Rate - Week 16	0.2 beats per minute (bpm) Standard Deviation 9.13
Change From Baseline in Supine and Standing Pulse Rate at Weeks 16 and 52 Supine Heart Rate - Week 52	-2.3 beats per minute (bpm) Standard Deviation 11.22
Change From Baseline in Supine and Standing Pulse Rate at Weeks 16 and 52 Standing Heart Rate - Week 16	0.2 beats per minute (bpm) Standard Deviation 10.32
Change From Baseline in Supine and Standing Pulse Rate at Weeks 16 and 52 Standing Heart Rate - Week 52	0.0 beats per minute (bpm) Standard Deviation 9.43

Adverse Events

Ropinirole PR/XR (Treatment Phase)

Serious events: 5 serious events

Other events: 51 other events

Deaths: 0 deaths

Ropinirole PR/XR (Taper Phase)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ropinirole PR/XR (Treatment Phase) n=62 participants at risk Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 mg as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52.	Ropinirole PR/XR (Taper Phase) n=62 participants at risk The dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian neoplasm	1.6% 1/62	0.00% 0/62
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma	1.6% 1/62	0.00% 0/62
Gastrointestinal disorders Intestinal obstruction	1.6% 1/62	0.00% 0/62
Immune system disorders Anti-neutrophil cytoplasmic antibody positive vasculitis	1.6% 1/62	0.00% 0/62
Nervous system disorders Cerebral infarction	1.6% 1/62	0.00% 0/62
Renal and urinary disorders Glomerulonephritis rapidly progressive	1.6% 1/62	0.00% 0/62
Infections and infestations Pneumonia	0.00% 0/62	1.6% 1/62

Other adverse events

Other adverse events
Measure	Ropinirole PR/XR (Treatment Phase) n=62 participants at risk Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 mg as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52.	Ropinirole PR/XR (Taper Phase) n=62 participants at risk The dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
Gastrointestinal disorders Nausea	29.0% 18/62	0.00% 0/62
Gastrointestinal disorders Constipation	25.8% 16/62	0.00% 0/62
Gastrointestinal disorders Vomiting	8.1% 5/62	0.00% 0/62
Gastrointestinal disorders Stomach discomfort	6.5% 4/62	0.00% 0/62
Nervous system disorders Somnolence	40.3% 25/62	0.00% 0/62
Nervous system disorders Dizziness	8.1% 5/62	0.00% 0/62
Nervous system disorders Headache	8.1% 5/62	0.00% 0/62
Psychiatric disorders Hallucination	21.0% 13/62	0.00% 0/62
Infections and infestations Nasopharyngitis	19.4% 12/62	0.00% 0/62
Infections and infestations Bronchitis	6.5% 4/62	0.00% 0/62
General disorders Edema peripheral	6.5% 4/62	0.00% 0/62
Musculoskeletal and connective tissue disorders Back pain	6.5% 4/62	0.00% 0/62

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER