A Study to Evaluate the Efficacy of 18 to 24mg/Day Ropinirole Controlled Release (CR) Tablets in Early and Advanced Parkinson's Disease (PD) Patients.

A Study ROP116991, Clinical Evaluation of 18 to 24mg/Day Ropinirole CR for Parkinson's Disease.

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01929317

Enrollment

Registered

2013-08-27

Start date

2013-08-28

Completion date

2015-06-09

Last updated

2018-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Ropinirole, Parkinson's disease

Brief summary

This study is a Phase III, multicentre, randomized, initial double-blind study with subsequent open label phases. The study will havea screening phase (4 weeks), a dose increase effect verification phase (12 weeks), a down titration 1 phase (1 week), a long-term phase (39 weeks), down titration 2 phase (1 to 2 weeks) and a follow up phase. Subjects will be assigned to Ropinirole CR high-dose group or Ropinirole CR maintenance group at a ratio of 3:1. This study is being conducted to evaluate the efficacy (effect of increasing Ropinirole dose from 16 mg/day to 18-24 mg/day) of the Ropinirole CR tablets in early and advanced PD patients who have not achieved an optimal therapeutic response with marketed Ropinirole Immediate release (IR) (15 mg/day) or marketed Ropinirole CR (16 mg/day) formulations.

Interventions

DRUGRopinirole CR 2mg tablet

Ropinirole CR 2mg tablets will be supplied as white oval film-coated tablets.

DRUGRopinirole CR 8mg tablet

Ropinirole CR 8mg tablets will be supplied as white oval film-coated tablets.

DRUGRopinirole CR matching Placebo tablet

Ropinirole CR matching Placebo tablet tablets (containing no active ingredients) indistinguishable in appearance from Ropinirole CR 2 mg tablets.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

Inclusion criteria at the start of the screening * Patients who are diagnosed as Parkinson's Disease with severity of the modified Hoehn & Yahr criteria Stages I-IV. * 1\) Monotherapy subject: Subjects who have never received L-dopa, or subjects who have had prior exposure to L-dopa (up to 450 milligram (mg)/day) for up to 3 months in total and L-dopa treatment has been discontinued, for a minimum of 4 weeks prior to the screening phase. 2) L-dopa adjunct subject: Subjects receiving L-dopa (up to 450 mg/day) for at least 4 weeks prior to the screening phase. * Patients receiving 15mg/day Ropinirole IR or 16mg/day Ropinirole CR for 4 weeks prior to the screening phase, UPDRS Part III total (on) scores is 10 points or more at screening visit and can expect clinical efficacy by increasing Ropinirole CR. * Age: 20years or older (at the time of informed written consent) * Informed consent: Patients who are able to give informed written consent in person. (i.e. patients who are capable of giving informed written consent on their own) * Sex: Either sex. Women of child-bearing potential will be eligible for inclusion in this study. However they have to have a negative pregnancy test at the screening visit and will have to agree to further pregnancy testing at the time points determined in study assessments and procedures and practice one of the methods of contraception mentioned in the protocol from the screening visit until the end of the follow-up examination - Outpatient status * corrected QT (QTc) \<450 millisecond (msec) or \<480msec for subjects with Bundle Branch Block. The QTc should be based on single or averaged QTc values of triplicate electrocardiograms (ECGs) obtained over a brief recording period. * Liver function tests: Patients with aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2x upper limit of normal (ULN); and Alkaline Phosphatase and bilirubin =\< 1.5xULN (isolated bilirubin \> 1.5ULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35%) at the screening visit. Randomization Criteria * Patients whose UPDRS Part III total (on) scores is 10 points or more at week 0 * Patients who did not achieve an optimal therapeutic response by treatment with 16mg/day Ropinirole CR and required higher dose of Ropinirole CR * Patients who are 80% or more compliant taking study drug

Exclusion criteria

* Late stage advanced patients demonstrating incapacitating peak dose or biphasic dyskinsia on their stable dose of L-dopa. * Patients who have used any other dopamine agonist (except for Ropinirole IR and CR) within 4 weeks prior to the screening phase. * Patients who have been treated with the following drugs at 4 weeks or earlier before the start of the screening phase, and whose treatment regimen of the drug has been changed. Anticholinergic agents: trihexyphenidyl hydrochloride, piroheptine hydrochloride, mazaticol hydrochloride, metixene hydrochloride, biperiden hydrochloride, profenamine, amantadine hydrochloride,droxidopa, citicoline, selegiline hydrochloride, entacapone, zonisamide, Estrogens, CYP1A2 inhibitors. * Patients who have been changing in smoking habit (started or stopped smoking) within the screening phase. * Patients who have been treated with any other investigational drug within 12 weeks prior to the screening phase. * Patients who present serious physical signs and symptoms other than those of the PD (e.g. cardiac/hepatic/renal disorder and haematopoietic disorder). * Patients with symptomatic postural hypotension. (e.g. dizziness and syncope). * Patients with a current or history of drug abuse or alcoholism. * Patients with severe dementia such as score 3 or 4 of the UPDRS item 1 (Mentation, behaviour, and mood). * Patients with current or history of major psychosis (e.g. schizophrenia or psychotic depression) such as score 3 or 4 of the UPDRS item 2 (thought disorder) or item 3(depression). * Patients who have received surgical treatment for PD in the past (e.g. pallidectomy, deep brain stimulation). * Female patients who are pregnant or lactating, who may be pregnant, or who plan for pregnancy during the study or within 30 days after the last dose of the study drug. * Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulapathy, hypoalbuminaemia, oesophageal or gastric varices or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). Chronic hepatitis B administered immunosuppressive agents due to risk of hapatitis B reactivation. * Patients with a history of drug allergy to Ropinirole hydrochloride. * Except for patients with a history of basal cell carcinoma, patients with a current or history of cancer or malignant tumor within 5 years prior to the screening phase. * Others whom the investigator (subinvestigator) considers ineligible for the study.

Design outcomes

Primary

Measure	Time frame	Description
Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at Week 12 in the CR High-dose Group	Baseline and Week 12	The Japanese Unified Parkinson's Disease Rating Scale (UPDRS) assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Baseline is defined as the value evaluated at Week 0. Mean change from Baseline was calculated as the total score at Week 12 minus the total score at Baseline. The analyses for the Dose Increase Effect Verification Phase was performed using the last observation carried forward (LOCF) data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase.

Secondary

Measure	Time frame	Description
Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Baseline, Weeks, 2, 4, 6, 8 and 12	The Japanese UPDRS assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Number of participants achieving a 30% or greater and 20% or greater reduction from Baseline in UPDRS total part III score at Weeks 2, 4, 6, 8, and 12 are presented using LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase.
Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Baseline, Weeks, 2, 4, 6, 8 and 12	The Japanese UPDRS assesses the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at the planned visit.
Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Baseline, Weeks, 2, 4, 6, 8 and 12	The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluated activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. On state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations.
Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Baseline, Weeks, 2, 4, 6, 8 and 12	The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for No and 1 for Yes. The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.
Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Baseline, Weeks, 2, 4, 6, 8 and 12	The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.
Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Baseline, Weeks, 2, 4, 6, 8 and 12	The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. On state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations.
Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Baseline, Weeks, 2, 4, 6, 8 and 12	The Japanese UPDRS assessed the status of PD participants objectively. Part 3 evaluated motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.
Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Baseline, Weeks, 2, 4, 6, 8 and 12	The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for No and 1 for Yes. The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.
Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long-term Phase	Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52	The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms.Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data. Full Analysis Set 2 (FAS2) Population comprised of all participants in the FAS1 and shifted to Long-term Phase, excluding those participants who received no dose of study medication and participants without UPDRS part III total score data after supply of the investigational product.
Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase	Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52	The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms.Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value at Week 13. If the value at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. On state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations.
Mean Change From Baseline in UPDRS Part 3 Total Score at the Indicated Visits for Long Term Phase	Baseline (Week 13), Weeks 17, 21, 25, 37, 49, 52	The Japanese UPDRS assesses the status of PD participants objectively. Part 3 evaluates motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.
Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long Term Phase	Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52	The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for No and 1 for Yes. The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms.Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.
Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long Term Phase	Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52	The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.
Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase	Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52	The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value at Week 13. If the value at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. On state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations.
Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits	Baseline, Weeks, 2, 4, 6, 8 and 12	The Japanese Unified Parkinson's Disease Rating Scale (UPDRS) assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Baseline is defined as the value evaluated at Week 0. Mean change from Baseline was calculated as the total score at Week 12 minus the total score at Baseline. The analyses for the Dose Increase Effect Verification Phase was performed using the last observation carried forward (LOCF) data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase.
Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long-term Phase	Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52	The Japanese UPDRS assesses the status of PD participants objectively. Part 4 evaluates complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for No and 1 for Yes. The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.
Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Baseline, Weeks, 2, 4, 6, 8 and 12	Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their off periods and asleep in diary cards every day. Change from Baseline in awake time spent Off(actual hours) is calculated as awake time spent Off (hours) at the indicated visit minus awake time spent Off (hours) at Baseline. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.
Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Baseline, Weeks, 2, 4, 6, 8 and 12	Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their off periods and asleep in diary cards every day. Percentage of awake time spent off is defined as sum of two days off time (hours) divided by sum of two days awake time (hours) and multiplied by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent off) from the post Baseline value (percentage of awake time spent off). Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.
Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Baseline, Weeks, 2, 4, 6, 8 and 12	On state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their off periods and asleep in diary cards every day. Change from Baseline in awake time spent On(actual hours) is calculated as awake time spent On (hours) at the indicated visit minus awake time spent On (hours) at Baseline. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.
Change From Baseline in Actual Hours of Awake Time Spent OnWithout Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Baseline, Weeks, 2, 4, 6, 8 and 12	On state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their off periods and asleep in diary cards every day. Change from Baseline in awake time spent On without troublesome dyskinesias (actual hours) is calculated as \[awake time spent On minus awake time spent On with troublesome dyskinesias\] (hours) at visit minus \[awake time spent On minus awake time spent On with troublesome dyskinesias\] (hours) at Baseline. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.
Number of Participants With an Improvement (Responder) in the Clinical Global Impression (CGI) Global Improvement Scale at Week 12	Week 12	The CGI global improvement scale allows the investigator to rate the participant's total improvement since the beginning of treatment (Baseline). Scores on the scale range from 1 to 7 (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse). Participants with a CGI global improvement score of \<=2 (representing much improved or very much improved) were considered to be moderate improvement (responder). The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.
Number of Participants Remaining in the Study	From the start of the study medication (Week 0) until Week 52	—
Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.	Baseline (Week 13), Weeks 17, 21, 25, 37, 49, 52	The Japanese UPDRS assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Number of participants achieving a 30% or greater and 20% or greater reduction from Baseline in UPDRS total part III score at Weeks 17, 21, 25, 37, 49 and 52,are presented using OC data. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The OC (observed Case) dataset was defined as the dataset consisting of observed data without any missing data imputation.
Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52	Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their off periods and asleep in diary cards every day. Change from Baseline was calculated by subtracting the Baseline value (actual hours of awake time spent off) from the week 17, 21, 25, 37, 49 and 52 value (proportion of awake time spent off). Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline.The analyses for long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data
Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52	Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their off periods and asleep in diary cards every day. Percentage of awake time spent off is defined as sum of two days off time (hours) divided by sum of two days awake time (hours) and multiplied by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent off) from week 17, 21, 25, 37, 49 and 52 value (percentage of awake time spent off). Baseline is defined as the value at Week 13, If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline. The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data.
Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52	On state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their off periods and asleep in diary cards every day. Change from Baseline in awake time spent On(actual hours) is calculated as awake time spent On (hours) at the week 17, 21, 25, 37, 49 and 52 value minus awake time spent On (hours) at Baseline. Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline. The analyses for Long term phase was performed using the OC data. The OC (observed Case) dataset was defined as the dataset consisting of observed data without any missing data imputation.
Change From Baseline in Actual Hours of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52	On state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their on periods and asleep in diary cards every day. Change from Baseline in awake time spent On without troublesome dyskinesias (actual hours) is calculated as \[awake time spent On minus awake time spent On with troublesome dyskinesias\] (hours) at visit minus \[awake time spent On minus awake time spent On with troublesome dyskinesias\] (hours) at Baseline. Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline. The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data
Change From Baseline in Percentage of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52	On state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their on periods and asleep in diary cards every day. Percentage of awake time spent on is defined as sum of two days on time (hours) divided by sum of two days awake time (hours) and multiplified by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent on) from week 17, 21, 25, 37, 49 and 52 value (percentage of awake time spent on). Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing the first observed value post week 13 was used as a Baseline.The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data.
Change From Baseline in Percentage of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52	On state is defined as the state at which PD symptoms are well controlled by the drug. Par. were asked to record the duration of their on periods and asleep in diary cards every day. Percentage of awake time spent On without troublesome dyskinesias is defined as sum of two days on time without troublesome dyskinesias \[On time minus On time with troublesome dyskinesias\] (hours) divided by sum of two days awake time (hours) and multiplified by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent On without troublesome dyskinesias) from week 17, 21, 25, 37, 49 and 52 value (percentage of awake time spent On without troublesome dyskinesias). Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing the first observed value post week 13 was used as a Baseline.The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data.
Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Long Term Phase	Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52	The Japanese UPDRS assessed the status of PD participants objectively. Part 3 evaluated motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.

Countries

Japan

Participant flow

Recruitment details

A total of 81 participants (par.) were randomized, of which 71 participants completed the Dose Increase Effect Verification (DIEV) Phase and 62 participants entered the Long-term Phase and 39 participants completing the Long-term Phase.

Pre-assignment details

This study was comprised of a Screening Phase (4 weeks), DIEV Phase (12 weeks), Down Titration 1 Phase (1 week), Long-term Phase (39 weeks), Down Titration 2 Phase (1 to 2 weeks) and the Follow-up Phase. The first 60 par. who completed the DIEV phase entered into the Long-term phase after a completion of the Down Titration 1 phase.

Participants by arm

Arm	Count
Ropinirole CR - High Dose Group Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	61
Ropinirole CR - Maintenance Dose Group Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.	20
Total	81

Withdrawals & dropouts

Period	Reason	FG000	FG001
Dose Increase Effect Verification Phase	Adverse Event	5	1
Dose Increase Effect Verification Phase	Physician Decision	1	0
Dose Increase Effect Verification Phase	Withdrawal by Subject	3	0
Long-term Phase	Adverse Event	5	1
Long-term Phase	Physician Decision	3	0
Long-term Phase	Protocol-defined Stopping Criteria	1	0
Long-term Phase	Protocol Violation	1	0
Long-term Phase	Study Closed/Terminated	5	3
Long-term Phase	Withdrawal by Subject	4	0

Baseline characteristics

Characteristic	Ropinirole CR - High Dose Group	Ropinirole CR - Maintenance Dose Group	Total
Age, Continuous	65.5 Years STANDARD_DEVIATION 8.95	63.3 Years STANDARD_DEVIATION 12.42	65.0 Years STANDARD_DEVIATION 9.88
Race/Ethnicity, Customized Japanese/East Asian Heritage (EAH)/South EAH	61 Participants	20 Participants	81 Participants
Sex: Female, Male Female	39 Participants	11 Participants	50 Participants
Sex: Female, Male Male	22 Participants	9 Participants	31 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	13 / 61	11 / 20	14 / 44	13 / 18
serious Total, serious adverse events	2 / 61	4 / 20	0 / 44	1 / 18

Outcome results

Primary

Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at Week 12 in the CR High-dose Group

The Japanese Unified Parkinson's Disease Rating Scale (UPDRS) assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Baseline is defined as the value evaluated at Week 0. Mean change from Baseline was calculated as the total score at Week 12 minus the total score at Baseline. The analyses for the Dose Increase Effect Verification Phase was performed using the last observation carried forward (LOCF) data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase.

Time frame: Baseline and Week 12

Population: Full Analysis Set 1 (FAS1) Population: all participants excluding those participants who received no dose of study medication and participants without UPDRS part III total score data after supply of the investigational product.

Arm	Measure	Value (MEAN)	Dispersion
Ropinirole CR - High Dose Group	Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at Week 12 in the CR High-dose Group	-4.8 Scores on a scale	Standard Deviation 5.95

p-value: <0.00195% CI: [-6.3, -3.2]t-test, 1 sided

Secondary

Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct

On state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their off periods and asleep in diary cards every day. Change from Baseline in awake time spent On(actual hours) is calculated as awake time spent On (hours) at the indicated visit minus awake time spent On (hours) at Baseline. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.

Time frame: Baseline, Weeks, 2, 4, 6, 8 and 12

Population: FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 population.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ropinirole CR - High Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 4, n=53, 18	-0.12 hours	Standard Deviation 2.271
Ropinirole CR - High Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 8, n=53, 18	-0.11 hours	Standard Deviation 2.759
Ropinirole CR - High Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 6, n=53, 18	-0.01 hours	Standard Deviation 2.474
Ropinirole CR - High Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 12, n=53, 18	0.07 hours	Standard Deviation 2.789
Ropinirole CR - High Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 2, n=53, 17	-0.39 hours	Standard Deviation 2.154
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 12, n=53, 18	-0.79 hours	Standard Deviation 1.815
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 2, n=53, 17	-0.46 hours	Standard Deviation 1.635
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 4, n=53, 18	-0.60 hours	Standard Deviation 2.18
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 6, n=53, 18	-0.61 hours	Standard Deviation 1.676
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 8, n=53, 18	-0.96 hours	Standard Deviation 1.554

95% CI: [-1.07, 1.21]

95% CI: [-0.75, 1.7]

95% CI: [-0.65, 1.86]

95% CI: [-0.52, 2.22]

95% CI: [-0.55, 2.26]

Secondary

Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase

On state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their off periods and asleep in diary cards every day. Change from Baseline in awake time spent On(actual hours) is calculated as awake time spent On (hours) at the week 17, 21, 25, 37, 49 and 52 value minus awake time spent On (hours) at Baseline. Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline. The analyses for Long term phase was performed using the OC data. The OC (observed Case) dataset was defined as the dataset consisting of observed data without any missing data imputation.

Time frame: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

Population: FAS2 Population who received L-dopa adjunct in Long term phase. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ropinirole CR - High Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 17, n=36, 15	0.56 hours	Standard Deviation 2.472
Ropinirole CR - High Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 21, n=34, 14	0.43 hours	Standard Deviation 1.585
Ropinirole CR - High Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 25, n=34, 15	-0.04 hours	Standard Deviation 1.434
Ropinirole CR - High Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 37, n=29, 15	0.26 hours	Standard Deviation 2.188
Ropinirole CR - High Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 49, n=26, 12	-0.19 hours	Standard Deviation 1.764
Ropinirole CR - High Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 52, n=23, 12	0.36 hours	Standard Deviation 1.539
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 49, n=26, 12	-0.56 hours	Standard Deviation 3.163
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 17, n=36, 15	0.57 hours	Standard Deviation 2.376
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 37, n=29, 15	0.37 hours	Standard Deviation 3.266
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 21, n=34, 14	0.73 hours	Standard Deviation 2.006
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 52, n=23, 12	-0.56 hours	Standard Deviation 2.358
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 25, n=34, 15	0.23 hours	Standard Deviation 1.896

Secondary

Change From Baseline in Actual Hours of Awake Time Spent OnWithout Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct

On state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their off periods and asleep in diary cards every day. Change from Baseline in awake time spent On without troublesome dyskinesias (actual hours) is calculated as \[awake time spent On minus awake time spent On with troublesome dyskinesias\] (hours) at visit minus \[awake time spent On minus awake time spent On with troublesome dyskinesias\] (hours) at Baseline. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.

Time frame: Baseline, Weeks, 2, 4, 6, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Ropinirole CR - High Dose Group	Change From Baseline in Actual Hours of Awake Time Spent OnWithout Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 4, n=53, 18	-0.14 hours	Standard Deviation 2.359
Ropinirole CR - High Dose Group	Change From Baseline in Actual Hours of Awake Time Spent OnWithout Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 8, n=53, 18	-0.05 hours	Standard Deviation 2.896
Ropinirole CR - High Dose Group	Change From Baseline in Actual Hours of Awake Time Spent OnWithout Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 6, n=53, 18	-0.06 hours	Standard Deviation 2.566
Ropinirole CR - High Dose Group	Change From Baseline in Actual Hours of Awake Time Spent OnWithout Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 12, n=53, 18	0.11 hours	Standard Deviation 2.968
Ropinirole CR - High Dose Group	Change From Baseline in Actual Hours of Awake Time Spent OnWithout Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 2, n=53, 17	-0.40 hours	Standard Deviation 2.276
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Actual Hours of Awake Time Spent OnWithout Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 12, n=53, 18	-0.74 hours	Standard Deviation 1.733
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Actual Hours of Awake Time Spent OnWithout Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 2, n=53, 17	-0.59 hours	Standard Deviation 1.4
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Actual Hours of Awake Time Spent OnWithout Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 4, n=53, 18	-0.71 hours	Standard Deviation 1.745
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Actual Hours of Awake Time Spent OnWithout Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 6, n=53, 18	-0.63 hours	Standard Deviation 1.476
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Actual Hours of Awake Time Spent OnWithout Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 8, n=53, 18	-1.01 hours	Standard Deviation 1.549

95% CI: [-0.98, 1.36]

95% CI: [-0.64, 1.78]

95% CI: [-0.71, 1.84]

95% CI: [-0.47, 2.39]

95% CI: [-0.63, 2.33]

Secondary

Change From Baseline in Actual Hours of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase

On state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their on periods and asleep in diary cards every day. Change from Baseline in awake time spent On without troublesome dyskinesias (actual hours) is calculated as \[awake time spent On minus awake time spent On with troublesome dyskinesias\] (hours) at visit minus \[awake time spent On minus awake time spent On with troublesome dyskinesias\] (hours) at Baseline. Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline. The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data

Time frame: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Ropinirole CR - High Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 17, n=36, 15	0.24 hours	Standard Deviation 2.245
Ropinirole CR - High Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 21, n=34, 14	0.21 hours	Standard Deviation 1.85
Ropinirole CR - High Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 25, n=34, 15	-0.15 hours	Standard Deviation 1.341
Ropinirole CR - High Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 37, n=29, 15	-0.09 hours	Standard Deviation 2.247
Ropinirole CR - High Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 49, n=26, 12	-0.50 hours	Standard Deviation 1.877
Ropinirole CR - High Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 52, n=23, 12	0.08 hours	Standard Deviation 1.378
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 49, n=26, 12	0.04 hours	Standard Deviation 2.72
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 17, n=36, 15	0.60 hours	Standard Deviation 2.347
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 37, n=29, 15	1.02 hours	Standard Deviation 3.447
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 21, n=34, 14	1.23 hours	Standard Deviation 2.403
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 52, n=23, 12	-0.21 hours	Standard Deviation 2.886
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Actual Hours of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 25, n=34, 15	0.25 hours	Standard Deviation 2.615

Secondary

Change From Baseline in Percentage of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase

On state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their on periods and asleep in diary cards every day. Percentage of awake time spent on is defined as sum of two days on time (hours) divided by sum of two days awake time (hours) and multiplified by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent on) from week 17, 21, 25, 37, 49 and 52 value (percentage of awake time spent on). Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing the first observed value post week 13 was used as a Baseline.The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data.

Time frame: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Ropinirole CR - High Dose Group	Change From Baseline in Percentage of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 17, n=36, 15	2.81 percentage of awake time spent on	Standard Deviation 13.529
Ropinirole CR - High Dose Group	Change From Baseline in Percentage of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 21, n=34, 14	1.20 percentage of awake time spent on	Standard Deviation 9.841
Ropinirole CR - High Dose Group	Change From Baseline in Percentage of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 25, n=34, 15	-1.02 percentage of awake time spent on	Standard Deviation 7.813
Ropinirole CR - High Dose Group	Change From Baseline in Percentage of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 37, n=29, 15	0.13 percentage of awake time spent on	Standard Deviation 12.766
Ropinirole CR - High Dose Group	Change From Baseline in Percentage of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 49, n=26, 12	-0.23 percentage of awake time spent on	Standard Deviation 10.389
Ropinirole CR - High Dose Group	Change From Baseline in Percentage of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 52, n=23, 12	1.80 percentage of awake time spent on	Standard Deviation 8.706
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Percentage of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 49, n=26, 12	-2.68 percentage of awake time spent on	Standard Deviation 18.578
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Percentage of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 17, n=36, 15	3.82 percentage of awake time spent on	Standard Deviation 15.452
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Percentage of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 37, n=29, 15	3.27 percentage of awake time spent on	Standard Deviation 19.048
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Percentage of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 21, n=34, 14	4.62 percentage of awake time spent on	Standard Deviation 12.211
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Percentage of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 52, n=23, 12	-1.14 percentage of awake time spent on	Standard Deviation 13.313
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Percentage of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 25, n=34, 15	3.42 percentage of awake time spent on	Standard Deviation 9.982

Secondary

Change From Baseline in Percentage of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase

On state is defined as the state at which PD symptoms are well controlled by the drug. Par. were asked to record the duration of their on periods and asleep in diary cards every day. Percentage of awake time spent On without troublesome dyskinesias is defined as sum of two days on time without troublesome dyskinesias \[On time minus On time with troublesome dyskinesias\] (hours) divided by sum of two days awake time (hours) and multiplified by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent On without troublesome dyskinesias) from week 17, 21, 25, 37, 49 and 52 value (percentage of awake time spent On without troublesome dyskinesias). Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing the first observed value post week 13 was used as a Baseline.The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data.

Time frame: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Ropinirole CR - High Dose Group	Change From Baseline in Percentage of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 17, n=36, 15	0.70 percentage of awake time spent on	Standard Deviation 11.655
Ropinirole CR - High Dose Group	Change From Baseline in Percentage of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 21, n=34, 14	-0.16 percentage of awake time spent on	Standard Deviation 11.73
Ropinirole CR - High Dose Group	Change From Baseline in Percentage of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 25, n=34, 15	-1.70 percentage of awake time spent on	Standard Deviation 7.765
Ropinirole CR - High Dose Group	Change From Baseline in Percentage of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 37, n=29, 15	-1.71 percentage of awake time spent on	Standard Deviation 13.698
Ropinirole CR - High Dose Group	Change From Baseline in Percentage of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 49, n=26, 12	-2.00 percentage of awake time spent on	Standard Deviation 11.835
Ropinirole CR - High Dose Group	Change From Baseline in Percentage of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 52, n=23, 12	-0.05 percentage of awake time spent on	Standard Deviation 7.521
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Percentage of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 49, n=26, 12	0.45 percentage of awake time spent on	Standard Deviation 15.958
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Percentage of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 17, n=36, 15	4.04 percentage of awake time spent on	Standard Deviation 15.472
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Percentage of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 37, n=29, 15	6.93 percentage of awake time spent on	Standard Deviation 19.472
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Percentage of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 21, n=34, 14	7.31 percentage of awake time spent on	Standard Deviation 13.78
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Percentage of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 52, n=23, 12	0.53 percentage of awake time spent on	Standard Deviation 14.966
Ropinirole CR - Maintenance Dose Group	Change From Baseline in Percentage of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 25, n=34, 15	3.10 percentage of awake time spent on	Standard Deviation 15.036

Secondary

Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct

Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their off periods and asleep in diary cards every day. Change from Baseline in awake time spent Off(actual hours) is calculated as awake time spent Off (hours) at the indicated visit minus awake time spent Off (hours) at Baseline. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.

Time frame: Baseline, Weeks, 2, 4, 6, 8 and 12

Population: FAS1 Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ropinirole CR - High Dose Group	Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 4	0.09 hours	Standard Deviation 2.308
Ropinirole CR - High Dose Group	Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 8	-0.08 hours	Standard Deviation 2.552
Ropinirole CR - High Dose Group	Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 6	0.01 hours	Standard Deviation 2.645
Ropinirole CR - High Dose Group	Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 12	-0.27 hours	Standard Deviation 2.781
Ropinirole CR - High Dose Group	Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 2	0.14 hours	Standard Deviation 2.26
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 12	0.81 hours	Standard Deviation 1.953
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 2	0.44 hours	Standard Deviation 1.605
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 4	0.04 hours	Standard Deviation 1.817
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 6	0.37 hours	Standard Deviation 2.068
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 8	0.77 hours	Standard Deviation 2.442

95% CI: [-1.65, 1.04]

95% CI: [-1.34, 1.45]

95% CI: [-1.95, 1.24]

95% CI: [-2.44, 0.75]

95% CI: [-2.73, 0.58]

Secondary

Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase

Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their off periods and asleep in diary cards every day. Change from Baseline was calculated by subtracting the Baseline value (actual hours of awake time spent off) from the week 17, 21, 25, 37, 49 and 52 value (proportion of awake time spent off). Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline.The analyses for long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data

Time frame: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Ropinirole CR - High Dose Group	Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 17, n=26, 13	-0.63 hours	Standard Deviation 2.6
Ropinirole CR - High Dose Group	Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 21, n=24, 12	-0.40 hours	Standard Deviation 1.892
Ropinirole CR - High Dose Group	Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 25, n=24, 13	0.04 hours	Standard Deviation 1.442
Ropinirole CR - High Dose Group	Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 37, n=20, 13	0.01 hours	Standard Deviation 2.999
Ropinirole CR - High Dose Group	Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 49, n=18, 11	-0.24 hours	Standard Deviation 1.945
Ropinirole CR - High Dose Group	Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 52, n=15, 11	-0.62 hours	Standard Deviation 1.797
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 49, n=18, 11	0.91 hours	Standard Deviation 3.117
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 17, n=26, 13	-0.50 hours	Standard Deviation 1.829
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 37, n=20, 13	-0.46 hours	Standard Deviation 2.252
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 21, n=24, 12	-0.65 hours	Standard Deviation 1.428
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 52, n=15, 11	0.45 hours	Standard Deviation 2.255
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 25, n=24, 13	-0.52 hours	Standard Deviation 1.325

Secondary

Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase

The Japanese UPDRS assesses the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at the planned visit.

Time frame: Baseline, Weeks, 2, 4, 6, 8 and 12

Population: FAS1 Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 4	-0.1 Scores on a scale	Standard Deviation 0.57
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 8	-0.1 Scores on a scale	Standard Deviation 0.68
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 6	-0.1 Scores on a scale	Standard Deviation 0.69
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 12	0.1 Scores on a scale	Standard Deviation 0.89
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 2	-0.0 Scores on a scale	Standard Deviation 0.5
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 12	-0.1 Scores on a scale	Standard Deviation 0.45
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 2	-0.1 Scores on a scale	Standard Deviation 0.31
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 4	-0.2 Scores on a scale	Standard Deviation 0.49
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 6	-0.1 Scores on a scale	Standard Deviation 0.45
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 8	-0.1 Scores on a scale	Standard Deviation 0.45

95% CI: [-0.2, 0.3]

95% CI: [-0.2, 0.4]

95% CI: [-0.4, 0.3]

95% CI: [-0.3, 0.3]

95% CI: [-0.2, 0.6]

Secondary

Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long-term Phase

The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms.Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data. Full Analysis Set 2 (FAS2) Population comprised of all participants in the FAS1 and shifted to Long-term Phase, excluding those participants who received no dose of study medication and participants without UPDRS part III total score data after supply of the investigational product.

Time frame: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

Population: FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long-term Phase	Week 17; n=42,17	0.1 Scores on a scale	Standard Deviation 0.45
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long-term Phase	Week 21; n=40, 16	0.2 Scores on a scale	Standard Deviation 0.88
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long-term Phase	Week 25; n=40, 17	0.2 Scores on a scale	Standard Deviation 0.86
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long-term Phase	Week 37; n=33, 17	0.2 Scores on a scale	Standard Deviation 1.02
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long-term Phase	Week 49; n=26, 14	0.2 Scores on a scale	Standard Deviation 0.51
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long-term Phase	Week 52; n=25, 14	0.2 Scores on a scale	Standard Deviation 0.58
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long-term Phase	Week 49; n=26, 14	0.1 Scores on a scale	Standard Deviation 0.73
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long-term Phase	Week 17; n=42,17	0.1 Scores on a scale	Standard Deviation 0.56
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long-term Phase	Week 37; n=33, 17	0.1 Scores on a scale	Standard Deviation 0.9
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long-term Phase	Week 21; n=40, 16	-0.2 Scores on a scale	Standard Deviation 0.66
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long-term Phase	Week 52; n=25, 14	0.2 Scores on a scale	Standard Deviation 0.97
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long-term Phase	Week 25; n=40, 17	-0.1 Scores on a scale	Standard Deviation 0.83

Secondary

Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase

The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluated activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. On state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations.

Time frame: Baseline, Weeks, 2, 4, 6, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 2, On status, n=61, 20	-1.0 Scores on a scale	Standard Deviation 2
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 4, On status, n=61, 20	-1.4 Scores on a scale	Standard Deviation 2.6
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 6, On status, n=61, 20	-1.6 Scores on a scale	Standard Deviation 3.03
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 8, On status, n=61, 20	-1.4 Scores on a scale	Standard Deviation 3.23
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 12, On status, n=61, 20	-1.1 Scores on a scale	Standard Deviation 3.61
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 2, Off status, n=53, 18	-1.0 Scores on a scale	Standard Deviation 2.13
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 4, Off status, n=53, 18	-1.3 Scores on a scale	Standard Deviation 3.23
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 6, Off status, n=53, 18	-1.7 Scores on a scale	Standard Deviation 3.9
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 8, Off status, n=53, 18	-1.4 Scores on a scale	Standard Deviation 3.92
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 12, Off status, n=53, 18	-1.4 Scores on a scale	Standard Deviation 4.25
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 6, Off status, n=53, 18	-0.8 Scores on a scale	Standard Deviation 2.26
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 2, On status, n=61, 20	-0.2 Scores on a scale	Standard Deviation 0.99
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 2, Off status, n=53, 18	-0.3 Scores on a scale	Standard Deviation 1.97
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 4, On status, n=61, 20	-0.3 Scores on a scale	Standard Deviation 1.63
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 12, Off status, n=53, 18	-1.3 Scores on a scale	Standard Deviation 2.52
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 6, On status, n=61, 20	-0.5 Scores on a scale	Standard Deviation 2.04
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 4, Off status, n=53, 18	-0.4 Scores on a scale	Standard Deviation 2.89
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 8, On status, n=61, 20	-0.2 Scores on a scale	Standard Deviation 2.23
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 8, Off status, n=53, 18	-1.3 Scores on a scale	Standard Deviation 2.27
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 12, On status, n=61, 20	-0.2 Scores on a scale	Standard Deviation 2.64

95% CI: [-1.8, 0.1]

95% CI: [-2.4, 0.1]

95% CI: [-2.6, 0.3]

95% CI: [-2.8, 0.3]

95% CI: [-2.7, 0.7]

95% CI: [-1.8, 0.5]

95% CI: [-2.6, 0.8]

95% CI: [-2.8, 1]

95% CI: [-2.1, 1.8]

95% CI: [-2.2, 2.1]

Secondary

Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase

The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms.Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value at Week 13. If the value at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. On state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations.

Time frame: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase	Week 17, On status, n=42, 17	-0.1 Scores on a scale	Standard Deviation 1.52
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase	Week 21, On status, n=40, 16	-0.4 Scores on a scale	Standard Deviation 1.6
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase	Week 25, On status, n=40, 17	-0.2 Scores on a scale	Standard Deviation 1.91
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase	Week 37, On status, n=33, 17	0.0 Scores on a scale	Standard Deviation 2.32
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase	Week 49, On status, n=26, 14	0.0 Scores on a scale	Standard Deviation 2.41
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase	Week 52, On status, n=25, 14	-0.2 Scores on a scale	Standard Deviation 2.67
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase	Week 17, Off status, n=36, 15	-0.4 Scores on a scale	Standard Deviation 2.33
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase	Week 21, Off status, n=34, 14	-0.4 Scores on a scale	Standard Deviation 2.32
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase	Week 25, Off status, n=34, 15	-0.2 Scores on a scale	Standard Deviation 2.27
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase	Week 37, Off status, n=29, 15	0.9 Scores on a scale	Standard Deviation 3.77
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase	Week 49, Off status, n=24, 12	0.4 Scores on a scale	Standard Deviation 3.11
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase	Week 52, Off status, n=23, 12	0.4 Scores on a scale	Standard Deviation 2.52
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase	Week 49, Off status, n=24, 12	0.8 Scores on a scale	Standard Deviation 4.84
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase	Week 17, On status, n=42, 17	0.1 Scores on a scale	Standard Deviation 0.6
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase	Week 17, Off status, n=36, 15	-0.5 Scores on a scale	Standard Deviation 1.46
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase	Week 21, On status, n=40, 16	0.0 Scores on a scale	Standard Deviation 0.89
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase	Week 37, Off status, n=29, 15	0.0 Scores on a scale	Standard Deviation 5.01
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase	Week 25, On status, n=40, 17	-0.1 Scores on a scale	Standard Deviation 0.99
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase	Week 21, Off status, n=34, 14	-0.7 Scores on a scale	Standard Deviation 1.07
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase	Week 37, On status, n=33, 17	0.2 Scores on a scale	Standard Deviation 1.48
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase	Week 52, Off status, n=23, 12	0.8 Scores on a scale	Standard Deviation 4.32
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase	Week 49, On status, n=26, 14	0.6 Scores on a scale	Standard Deviation 1.7
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase	Week 25, Off status, n=34, 15	-1.5 Scores on a scale	Standard Deviation 3.14
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase	Week 52, On status, n=25, 14	0.1 Scores on a scale	Standard Deviation 1.35

Secondary

Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase

The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for No and 1 for Yes. The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.

Time frame: Baseline, Weeks, 2, 4, 6, 8 and 12

Population: FAS1 Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 4	-0.2 Scores on a scale	Standard Deviation 1.24
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 8	0.0 Scores on a scale	Standard Deviation 1.32
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 6	-0.2 Scores on a scale	Standard Deviation 1.43
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 12	-0.1 Scores on a scale	Standard Deviation 1.38
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 2	-0.3 Scores on a scale	Standard Deviation 1.1
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 12	0.1 Scores on a scale	Standard Deviation 1.29
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 2	-0.2 Scores on a scale	Standard Deviation 1.01
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 4	-0.2 Scores on a scale	Standard Deviation 1.39
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 6	-0.3 Scores on a scale	Standard Deviation 1.49
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 8	0.1 Scores on a scale	Standard Deviation 1.28

95% CI: [-0.7, 0.4]

95% CI: [-0.7, 0.6]

95% CI: [-0.7, 0.8]

95% CI: [-0.7, 0.7]

95% CI: [-0.9, 0.5]

Secondary

Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long Term Phase

The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for No and 1 for Yes. The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms.Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.

Time frame: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long Term Phase	Week 17, n=42, 17	0.1 Scores on a scale	Standard Deviation 0.97
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long Term Phase	Week 21, n=40, 16	0.3 Scores on a scale	Standard Deviation 1.01
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long Term Phase	Week 25, n=40, 17	0.4 Scores on a scale	Standard Deviation 0.83
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long Term Phase	Week 37; n=33;17	0.5 Scores on a scale	Standard Deviation 1.15
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long Term Phase	Week 49; n=26,14	0.9 Scores on a scale	Standard Deviation 1.28
Ropinirole CR - High Dose Group	Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long Term Phase	Week 52; n=25, 14	0.6 Scores on a scale	Standard Deviation 1.04
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long Term Phase	Week 49; n=26,14	1.2 Scores on a scale	Standard Deviation 2.72
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long Term Phase	Week 17, n=42, 17	-0.1 Scores on a scale	Standard Deviation 1.03
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long Term Phase	Week 37; n=33;17	1.1 Scores on a scale	Standard Deviation 2.8
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long Term Phase	Week 21, n=40, 16	-0.1 Scores on a scale	Standard Deviation 0.89
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long Term Phase	Week 52; n=25, 14	0.8 Scores on a scale	Standard Deviation 2.36
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long Term Phase	Week 25, n=40, 17	0.2 Scores on a scale	Standard Deviation 2.24

Secondary

Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct

Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their off periods and asleep in diary cards every day. Percentage of awake time spent off is defined as sum of two days off time (hours) divided by sum of two days awake time (hours) and multiplied by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent off) from the post Baseline value (percentage of awake time spent off). Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.

Time frame: Baseline, Weeks, 2, 4, 6, 8 and 12

Population: FAS1 Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ropinirole CR - High Dose Group	Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 4	0.62 percentage of awake time spent off	Standard Deviation 13.486
Ropinirole CR - High Dose Group	Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 8	0.19 percentage of awake time spent off	Standard Deviation 16.012
Ropinirole CR - High Dose Group	Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 6	-0.09 percentage of awake time spent off	Standard Deviation 15.677
Ropinirole CR - High Dose Group	Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 12	-1.24 percentage of awake time spent off	Standard Deviation 16.814
Ropinirole CR - High Dose Group	Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 2	1.36 percentage of awake time spent off	Standard Deviation 13.025
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 12	4.74 percentage of awake time spent off	Standard Deviation 11.214
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 2	2.39 percentage of awake time spent off	Standard Deviation 9.119
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 4	0.48 percentage of awake time spent off	Standard Deviation 10.116
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 6	2.70 percentage of awake time spent off	Standard Deviation 10.518
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct	Week 8	4.65 percentage of awake time spent off	Standard Deviation 12.04

95% CI: [-8.77, 6.71]

95% CI: [-7.94, 8.22]

95% CI: [-12.06, 6.49]

95% CI: [-14.06, 5.14]

95% CI: [-15.92, 3.96]

Secondary

Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase

Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their off periods and asleep in diary cards every day. Percentage of awake time spent off is defined as sum of two days off time (hours) divided by sum of two days awake time (hours) and multiplied by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent off) from week 17, 21, 25, 37, 49 and 52 value (percentage of awake time spent off). Baseline is defined as the value at Week 13, If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline. The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data.

Time frame: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Ropinirole CR - High Dose Group	Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 17, n=26, 13	-4.16 percentage of awake time spent off	Standard Deviation 15.734
Ropinirole CR - High Dose Group	Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 21, n=24, 12	-2.59 percentage of awake time spent off	Standard Deviation 10.682
Ropinirole CR - High Dose Group	Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 25, n=24, 13	0.49 percentage of awake time spent off	Standard Deviation 8.123
Ropinirole CR - High Dose Group	Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 37, n=20, 13	-0.99 percentage of awake time spent off	Standard Deviation 15.204
Ropinirole CR - High Dose Group	Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 49, n=18, 11	-1.33 percentage of awake time spent off	Standard Deviation 11.509
Ropinirole CR - High Dose Group	Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 52, n=15, 11	-3.62 percentage of awake time spent off	Standard Deviation 9.925
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 49, n=18, 11	2.93 percentage of awake time spent off	Standard Deviation 19.464
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 17, n=26, 13	-4.41 percentage of awake time spent off	Standard Deviation 16.606
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 37, n=20, 13	-4.56 percentage of awake time spent off	Standard Deviation 20.134
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 21, n=24, 12	-5.39 percentage of awake time spent off	Standard Deviation 13.102
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 52, n=15, 11	1.24 percentage of awake time spent off	Standard Deviation 13.957
Ropinirole CR - Maintenance Dose Group	Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase	Week 25, n=24, 13	-3.95 percentage of awake time spent off	Standard Deviation 10.677

Secondary

Mean Change From Baseline in UPDRS Part 3 Total Score at the Indicated Visits for Long Term Phase

The Japanese UPDRS assesses the status of PD participants objectively. Part 3 evaluates motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.

Time frame: Baseline (Week 13), Weeks 17, 21, 25, 37, 49, 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Ropinirole CR - High Dose Group	Mean Change From Baseline in UPDRS Part 3 Total Score at the Indicated Visits for Long Term Phase	Week 17; n=41, 16	-1.2 Scores on a scale	Standard Deviation 3.46
Ropinirole CR - High Dose Group	Mean Change From Baseline in UPDRS Part 3 Total Score at the Indicated Visits for Long Term Phase	Week 21, n=39, 16	-2.5 Scores on a scale	Standard Deviation 5.53
Ropinirole CR - High Dose Group	Mean Change From Baseline in UPDRS Part 3 Total Score at the Indicated Visits for Long Term Phase	Week 25, n=40, 17	-2.1 Scores on a scale	Standard Deviation 5.09
Ropinirole CR - High Dose Group	Mean Change From Baseline in UPDRS Part 3 Total Score at the Indicated Visits for Long Term Phase	Week 37; n=33, 17	-1.9 Scores on a scale	Standard Deviation 6.46
Ropinirole CR - High Dose Group	Mean Change From Baseline in UPDRS Part 3 Total Score at the Indicated Visits for Long Term Phase	Week 49; n=26, 14	-2.2 Scores on a scale	Standard Deviation 8.66
Ropinirole CR - High Dose Group	Mean Change From Baseline in UPDRS Part 3 Total Score at the Indicated Visits for Long Term Phase	Week 52; n=25, 14	-1.9 Scores on a scale	Standard Deviation 6.92
Ropinirole CR - Maintenance Dose Group	Mean Change From Baseline in UPDRS Part 3 Total Score at the Indicated Visits for Long Term Phase	Week 49; n=26, 14	0.6 Scores on a scale	Standard Deviation 7.38
Ropinirole CR - Maintenance Dose Group	Mean Change From Baseline in UPDRS Part 3 Total Score at the Indicated Visits for Long Term Phase	Week 17; n=41, 16	-0.7 Scores on a scale	Standard Deviation 5.03
Ropinirole CR - Maintenance Dose Group	Mean Change From Baseline in UPDRS Part 3 Total Score at the Indicated Visits for Long Term Phase	Week 37; n=33, 17	1.4 Scores on a scale	Standard Deviation 7.65
Ropinirole CR - Maintenance Dose Group	Mean Change From Baseline in UPDRS Part 3 Total Score at the Indicated Visits for Long Term Phase	Week 21, n=39, 16	-1.9 Scores on a scale	Standard Deviation 4.92
Ropinirole CR - Maintenance Dose Group	Mean Change From Baseline in UPDRS Part 3 Total Score at the Indicated Visits for Long Term Phase	Week 52; n=25, 14	-0.6 Scores on a scale	Standard Deviation 5.49
Ropinirole CR - Maintenance Dose Group	Mean Change From Baseline in UPDRS Part 3 Total Score at the Indicated Visits for Long Term Phase	Week 25, n=40, 17	-0.6 Scores on a scale	Standard Deviation 4.31

Secondary

Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits

Time frame: Baseline, Weeks, 2, 4, 6, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Ropinirole CR - High Dose Group	Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits	Week 4	-3.8 Scores on a scale	Standard Deviation 5.23
Ropinirole CR - High Dose Group	Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits	Week 8	-5.2 Scores on a scale	Standard Deviation 5.46
Ropinirole CR - High Dose Group	Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits	Week 6	-4.6 Scores on a scale	Standard Deviation 5.28
Ropinirole CR - High Dose Group	Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits	Week 12	-4.8 Scores on a scale	Standard Deviation 5.95
Ropinirole CR - High Dose Group	Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits	Week 2	-2.9 Scores on a scale	Standard Deviation 4.41
Ropinirole CR - Maintenance Dose Group	Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits	Week 12	-5.7 Scores on a scale	Standard Deviation 5.18
Ropinirole CR - Maintenance Dose Group	Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits	Week 2	-2.7 Scores on a scale	Standard Deviation 4.27
Ropinirole CR - Maintenance Dose Group	Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits	Week 4	-4.4 Scores on a scale	Standard Deviation 3.5
Ropinirole CR - Maintenance Dose Group	Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits	Week 6	-5.0 Scores on a scale	Standard Deviation 5.09
Ropinirole CR - Maintenance Dose Group	Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits	Week 8	-4.5 Scores on a scale	Standard Deviation 4.94

95% CI: [-2.4, 2]

95% CI: [-1.9, 3.1]

95% CI: [-2.3, 3]

95% CI: [-3.4, 2]

95% CI: [-2, 3.9]

Secondary

Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.

The Japanese UPDRS assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Number of participants achieving a 30% or greater and 20% or greater reduction from Baseline in UPDRS total part III score at Weeks 17, 21, 25, 37, 49 and 52,are presented using OC data. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The OC (observed Case) dataset was defined as the dataset consisting of observed data without any missing data imputation.

Time frame: Baseline (Week 13), Weeks 17, 21, 25, 37, 49, 52

Arm	Measure	Group	Value (NUMBER)
Ropinirole CR - High Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.	Week 37, >=20% reduction from Baseline; n=33,17	14 Participants
Ropinirole CR - High Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.	Week 25, >=30% reduction from Baseline; n=40, 17	9 Participants
Ropinirole CR - High Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.	Week 52, >=20% reduction from Baseline; n=25, 14	12 Participants
Ropinirole CR - High Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.	Week 37, >=30% reduction from Baseline; n=33,17	8 Participants
Ropinirole CR - High Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.	Week 25, >=20% reduction from Baseline; n=40, 17	16 Participants
Ropinirole CR - High Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.	Week 49, >=30% reduction from Baseline; n=26, 14	9 Participants
Ropinirole CR - High Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.	Week 17, >=30% reduction from Baseline; n=41,16	5 Participants
Ropinirole CR - High Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.	Week 52, >=30% reduction from Baseline; n=25, 14	6 Participants
Ropinirole CR - High Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.	Week 49, >=20% reduction from Baseline; n=26, 14	13 Participants
Ropinirole CR - High Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.	Week 17, >=20% reduction from Baseline; n=41,16	8 Participants
Ropinirole CR - High Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.	Week 21, >=30% reduction from Baseline; n=39,16	8 Participants
Ropinirole CR - High Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.	Week 21, >=20% reduction from Baseline; n=39,16	15 Participants
Ropinirole CR - Maintenance Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.	Week 21, >=30% reduction from Baseline; n=39,16	3 Participants
Ropinirole CR - Maintenance Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.	Week 25, >=20% reduction from Baseline; n=40, 17	3 Participants
Ropinirole CR - Maintenance Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.	Week 37, >=20% reduction from Baseline; n=33,17	3 Participants
Ropinirole CR - Maintenance Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.	Week 49, >=20% reduction from Baseline; n=26, 14	3 Participants
Ropinirole CR - Maintenance Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.	Week 52, >=20% reduction from Baseline; n=25, 14	4 Participants
Ropinirole CR - Maintenance Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.	Week 17, >=30% reduction from Baseline; n=41,16	2 Participants
Ropinirole CR - Maintenance Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.	Week 21, >=20% reduction from Baseline; n=39,16	3 Participants
Ropinirole CR - Maintenance Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.	Week 25, >=30% reduction from Baseline; n=40, 17	3 Participants
Ropinirole CR - Maintenance Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.	Week 37, >=30% reduction from Baseline; n=33,17	3 Participants
Ropinirole CR - Maintenance Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.	Week 49, >=30% reduction from Baseline; n=26, 14	1 Participants
Ropinirole CR - Maintenance Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.	Week 52, >=30% reduction from Baseline; n=25, 14	2 Participants
Ropinirole CR - Maintenance Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.	Week 17, >=20% reduction from Baseline; n=41,16	2 Participants

Secondary

Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase

The Japanese UPDRS assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Number of participants achieving a 30% or greater and 20% or greater reduction from Baseline in UPDRS total part III score at Weeks 2, 4, 6, 8, and 12 are presented using LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase.

Time frame: Baseline, Weeks, 2, 4, 6, 8 and 12

Population: FAS1 Population

Arm	Measure	Group	Value (NUMBER)
Ropinirole CR - High Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 2, 30% or greater reduction from Baseline	10 Participants
Ropinirole CR - High Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 4, 30% or greater reduction from Baseline	17 Participants
Ropinirole CR - High Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 6, 30% or greater reduction from Baseline	21 Participants
Ropinirole CR - High Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 8, 30% or greater reduction from Baseline	30 Participants
Ropinirole CR - High Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 12, 30% or greater reduction from Baseline	27 Participants
Ropinirole CR - High Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 2, 20% or greater reduction from Baseline	16 Participants
Ropinirole CR - High Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 4, 20% or greater reduction from Baseline	26 Participants
Ropinirole CR - High Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 6, 20% or greater reduction from Baseline	30 Participants
Ropinirole CR - High Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 8, 20% or greater reduction from Baseline	35 Participants
Ropinirole CR - High Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 12, 20% or greater reduction from Baseline	31 Participants
Ropinirole CR - Maintenance Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 6, 20% or greater reduction from Baseline	10 Participants
Ropinirole CR - Maintenance Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 2, 30% or greater reduction from Baseline	4 Participants
Ropinirole CR - Maintenance Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 2, 20% or greater reduction from Baseline	5 Participants
Ropinirole CR - Maintenance Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 4, 30% or greater reduction from Baseline	5 Participants
Ropinirole CR - Maintenance Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 12, 20% or greater reduction from Baseline	13 Participants
Ropinirole CR - Maintenance Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 6, 30% or greater reduction from Baseline	6 Participants
Ropinirole CR - Maintenance Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 4, 20% or greater reduction from Baseline	11 Participants
Ropinirole CR - Maintenance Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 8, 30% or greater reduction from Baseline	7 Participants
Ropinirole CR - Maintenance Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 8, 20% or greater reduction from Baseline	11 Participants
Ropinirole CR - Maintenance Dose Group	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 12, 30% or greater reduction from Baseline	7 Participants

Secondary

Number of Participants Remaining in the Study

Time frame: From the start of the study medication (Week 0) until Week 52

Population: Safety Population 2 (SP2) compraised of all participants who included in SP1 (receive at least one dose of medication in Dose Increase Effect Verification Phase) and shifted to Long-term Phase and received at least one dose of medication in Long-term Phase.

Arm	Measure	Value (NUMBER)
Ropinirole CR - High Dose Group	Number of Participants Remaining in the Study	25 Participants
Ropinirole CR - Maintenance Dose Group	Number of Participants Remaining in the Study	14 Participants

Secondary

Number of Participants With an Improvement (Responder) in the Clinical Global Impression (CGI) Global Improvement Scale at Week 12

The CGI global improvement scale allows the investigator to rate the participant's total improvement since the beginning of treatment (Baseline). Scores on the scale range from 1 to 7 (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse). Participants with a CGI global improvement score of \<=2 (representing much improved or very much improved) were considered to be moderate improvement (responder). The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.

Time frame: Week 12

Population: FAS1 Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Value (NUMBER)
Ropinirole CR - High Dose Group	Number of Participants With an Improvement (Responder) in the Clinical Global Impression (CGI) Global Improvement Scale at Week 12	19 Participants
Ropinirole CR - Maintenance Dose Group	Number of Participants With an Improvement (Responder) in the Clinical Global Impression (CGI) Global Improvement Scale at Week 12	6 Participants

Secondary

Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase

The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.

Time frame: Baseline, Weeks, 2, 4, 6, 8 and 12

Population: FAS1 Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 4	-14.5 Percent change	Standard Deviation 63.87
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 8	-16.4 Percent change	Standard Deviation 82.27
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 6	-15.2 Percent change	Standard Deviation 83.82
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 12	-7.4 Percent change	Standard Deviation 85.84
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 2	-6.2 Percent change	Standard Deviation 40.06
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 12	-29.2 Percent change	Standard Deviation 45.21
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 2	-16.7 Percent change	Standard Deviation 35.63
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 4	-41.7 Percent change	Standard Deviation 49.6
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 6	-29.2 Percent change	Standard Deviation 45.21
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 8	-29.2 Percent change	Standard Deviation 45.21

Secondary

Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long Term Phase

The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.

Time frame: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long Term Phase	Week 17, n=15, 7	13.3 Percent change	Standard Deviation 36.43
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long Term Phase	Week 21, n=14, 7	-7.1 Percent change	Standard Deviation 28.47
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long Term Phase	Week 25, n=14, 7	3.6 Percent change	Standard Deviation 48.89
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long Term Phase	Week 37; n=9, 7	0.0 Percent change	Standard Deviation 43.3
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long Term Phase	Week 49; n=6, 5	20.8 Percent change	Standard Deviation 40.05
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long Term Phase	Week 52; n=6, 5	12.5 Percent change	Standard Deviation 44.02
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long Term Phase	Week 49; n=6, 5	15.0 Percent change	Standard Deviation 85.88
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long Term Phase	Week 17, n=15, 7	-9.5 Percent change	Standard Deviation 71.27
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long Term Phase	Week 37; n=9, 7	-11.9 Percent change	Standard Deviation 77.41
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long Term Phase	Week 21, n=14, 7	-31.0 Percent change	Standard Deviation 53.08
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long Term Phase	Week 52; n=6, 5	5.0 Percent change	Standard Deviation 75.83
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long Term Phase	Week 25, n=14, 7	-26.2 Percent change	Standard Deviation 60.75

Secondary

Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase

The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. On state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations.

Time frame: Baseline, Weeks, 2, 4, 6, 8 and 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 2, On status, n=55, 16	-22.3 Percent change	Standard Deviation 35.46
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 4, On status, n=55, 16	-21.9 Percent change	Standard Deviation 43.38
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 6, On status, n=55, 16	-21.4 Percent change	Standard Deviation 48.64
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 8, On status, n=55, 16	-14.3 Percent change	Standard Deviation 75.53
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 12, On status, n=55, 16	-4.7 Percent change	Standard Deviation 102.75
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 2, Off status, n=48, 15	-11.7 Percent change	Standard Deviation 26.38
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 4, Off status, n=48, 15	-15.0 Percent change	Standard Deviation 36.35
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 6, Off status, n=48, 15	-17.0 Percent change	Standard Deviation 42.27
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 8, Off status, n=48, 15	-14.7 Percent change	Standard Deviation 40.53
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 12, Off status, n=48, 15	-15.2 Percent change	Standard Deviation 44.9
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 6, Off status, n=48, 15	-9.7 Percent change	Standard Deviation 17.69
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 2, On status, n=55, 16	-4.6 Percent change	Standard Deviation 20.29
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 2, Off status, n=48, 15	-4.2 Percent change	Standard Deviation 13.45
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 4, On status, n=55, 16	-13.0 Percent change	Standard Deviation 39.07
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 12, Off status, n=48, 15	-10.1 Percent change	Standard Deviation 14.02
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 6, On status, n=55, 16	-12.9 Percent change	Standard Deviation 53.71
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 4, Off status, n=48, 15	-4.4 Percent change	Standard Deviation 18.18
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 8, On status, n=55, 16	-9.0 Percent change	Standard Deviation 59.34
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 8, Off status, n=48, 15	-10.9 Percent change	Standard Deviation 16.68
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Week 12, On status, n=55, 16	-9.3 Percent change	Standard Deviation 63.12

Secondary

Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase

The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value at Week 13. If the value at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. On state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations.

Time frame: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase	Week 17, On status, n=35, 12	2.3 Percent change	Standard Deviation 62.37
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase	Week 21, On status, n=33, 11	-0.1 Percent change	Standard Deviation 62.87
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase	Week 25, On status, n=33, 12	-1.7 Percent change	Standard Deviation 41.5
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase	Week 37, On status, n=26, 12	8.0 Percent change	Standard Deviation 64.38
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase	Week 49, On status, n=20, 9	27.8 Percent change	Standard Deviation 99.17
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase	Week 52, On status, n=19, 9	7.5 Percent change	Standard Deviation 93.46
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase	Week 17, Off status, n=26, 13	-1.4 Percent change	Standard Deviation 29.1
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase	Week 21, Off status, n=24, 12	-4.4 Percent change	Standard Deviation 35.76
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase	Week 25, Off status, n=24, 13	1.4 Percent change	Standard Deviation 41.65
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase	Week 37, Off status, n=20, 13	6.1 Percent change	Standard Deviation 54.09
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase	Week 49, Off status, n=16, 11	1.9 Percent change	Standard Deviation 41.71
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase	Week 52, Off status, n=15, 11	7.1 Percent change	Standard Deviation 39.24
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase	Week 49, Off status, n=16, 11	44.5 Percent change	Standard Deviation 96.82
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase	Week 17, On status, n=35, 12	-5.8 Percent change	Standard Deviation 30.29
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase	Week 17, Off status, n=26, 13	-3.6 Percent change	Standard Deviation 14.44
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase	Week 21, On status, n=33, 11	-7.1 Percent change	Standard Deviation 36.34
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase	Week 37, Off status, n=20, 13	6.3 Percent change	Standard Deviation 50.27
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase	Week 25, On status, n=33, 12	-0.7 Percent change	Standard Deviation 46.77
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase	Week 21, Off status, n=24, 12	-6.0 Percent change	Standard Deviation 9.09
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase	Week 37, On status, n=26, 12	-8.6 Percent change	Standard Deviation 34.96
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase	Week 52, Off status, n=15, 11	26.2 Percent change	Standard Deviation 50.57
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase	Week 49, On status, n=20, 9	1.8 Percent change	Standard Deviation 54.21
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase	Week 25, Off status, n=24, 13	-5.2 Percent change	Standard Deviation 38.3
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase	Week 52, On status, n=19, 9	0.7 Percent change	Standard Deviation 54.13

Secondary

Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase

The Japanese UPDRS assessed the status of PD participants objectively. Part 3 evaluated motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.

Time frame: Baseline, Weeks, 2, 4, 6, 8 and 12

Population: FAS1 Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 12	-23.1 Percent change	Standard Deviation 29.88
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 2	-12.0 Percent change	Standard Deviation 18.69
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 4	-17.4 Percent change	Standard Deviation 23.29
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 6	-21.6 Percent change	Standard Deviation 23.96
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 8	-25.5 Percent change	Standard Deviation 26.97
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 8	-22.9 Percent change	Standard Deviation 25.02
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 6	-22.9 Percent change	Standard Deviation 23.74
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 2	-11.8 Percent change	Standard Deviation 22.78
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 12	-27.6 Percent change	Standard Deviation 28.37
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 4	-21.9 Percent change	Standard Deviation 18.81

Secondary

Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Long Term Phase

The Japanese UPDRS assessed the status of PD participants objectively. Part 3 evaluated motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.

Time frame: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Long Term Phase	Week 17, n=41, 16	-5.4 Percent change	Standard Deviation 20.98
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Long Term Phase	Week 21, n=39, 16	-10.5 Percent change	Standard Deviation 25.83
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Long Term Phase	Week 25, n=40, 17	-10.3 Percent change	Standard Deviation 31.99
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Long Term Phase	Week 37; n=33, 17	-6.4 Percent change	Standard Deviation 30.91
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Long Term Phase	Week 49; n=26, 14	-3.4 Percent change	Standard Deviation 46.73
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Long Term Phase	Week 52; n=25, 14	-4.1 Percent change	Standard Deviation 44.35
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Long Term Phase	Week 49; n=26, 14	43.2 Percent change	Standard Deviation 134.85
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Long Term Phase	Week 17, n=41, 16	6.2 Percent change	Standard Deviation 38.25
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Long Term Phase	Week 37; n=33, 17	50.2 Percent change	Standard Deviation 148.56
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Long Term Phase	Week 21, n=39, 16	-6.0 Percent change	Standard Deviation 35.72
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Long Term Phase	Week 52; n=25, 14	16.2 Percent change	Standard Deviation 77.23
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Long Term Phase	Week 25, n=40, 17	2.6 Percent change	Standard Deviation 36.71

Secondary

Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase

The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for No and 1 for Yes. The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.

Time frame: Baseline, Weeks, 2, 4, 6, 8 and 12

Population: FAS1 Population. Only those participants available at the specified time points were analyzed.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 4	-4.1 Percent change	Standard Deviation 41.73
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 8	1.4 Percent change	Standard Deviation 46.48
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 6	-7.2 Percent change	Standard Deviation 47.39
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 12	-6.6 Percent change	Standard Deviation 46.04
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 2	-7.9 Percent change	Standard Deviation 36.71
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 12	9.5 Percent change	Standard Deviation 30.44
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 2	-1.9 Percent change	Standard Deviation 31.59
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 4	-6.5 Percent change	Standard Deviation 35.97
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 6	-4.9 Percent change	Standard Deviation 36.92
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Week 8	3.5 Percent change	Standard Deviation 35.18

Secondary

Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long-term Phase

The Japanese UPDRS assesses the status of PD participants objectively. Part 4 evaluates complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for No and 1 for Yes. The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.

Time frame: Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52

Arm	Measure	Group	Value (MEAN)	Dispersion
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long-term Phase	Week 17, n=30, 15	13.1 Percent change	Standard Deviation 49.42
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long-term Phase	Week 21, n=28, 14	11.3 Percent change	Standard Deviation 48.62
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long-term Phase	Week 25, n=28, 15	16.4 Percent change	Standard Deviation 41.65
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long-term Phase	Week 37, n=23, 15	11.3 Percent change	Standard Deviation 38.32
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long-term Phase	Week 49, n=18, 13	27.5 Percent change	Standard Deviation 34.93
Ropinirole CR - High Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long-term Phase	Week 52, n=17, 13	23.7 Percent change	Standard Deviation 36.32
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long-term Phase	Week 49, n=18, 13	40.0 Percent change	Standard Deviation 123.78
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long-term Phase	Week 17, n=30, 15	7.1 Percent change	Standard Deviation 43.29
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long-term Phase	Week 37, n=23, 15	49.5 Percent change	Standard Deviation 139.78
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long-term Phase	Week 21, n=28, 14	6.8 Percent change	Standard Deviation 41.68
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long-term Phase	Week 52, n=17, 13	35.4 Percent change	Standard Deviation 104.67
Ropinirole CR - Maintenance Dose Group	Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long-term Phase	Week 25, n=28, 15	18.7 Percent change	Standard Deviation 101.42

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026

A Study to Evaluate the Efficacy of 18 to 24mg/Day Ropinirole Controlled Release (CR) Tablets in Early and Advanced Parkinson's Disease (PD) Patients.

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Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at Week 12 in the CR High-dose Group

Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct

Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase

Change From Baseline in Actual Hours of Awake Time Spent OnWithout Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct

Change From Baseline in Actual Hours of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase

Change From Baseline in Percentage of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase

Change From Baseline in Percentage of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase

Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct

Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase

Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase

Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long-term Phase

Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase

Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase

Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase

Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long Term Phase

Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct

Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase

Mean Change From Baseline in UPDRS Part 3 Total Score at the Indicated Visits for Long Term Phase

Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits

Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.

Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase

Number of Participants Remaining in the Study

Number of Participants With an Improvement (Responder) in the Clinical Global Impression (CGI) Global Improvement Scale at Week 12

Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase

Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long Term Phase

Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase

Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase

Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase

Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Long Term Phase

Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase

Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long-term Phase