Parkinson Disease
Conditions
Keywords
Parkinson's Disease, PD
Brief summary
This study was designed to evaluate the pharmacokinetic profile, safety and efficacy in Parkinson's Disease patients.
Interventions
DRUGRopinirole prolonged release/extended release(PR/XR)
Subjects will take the investigational drug once daily at the same time each day, it is recommended that this is in the morning for optimal benefit. Investigational drug is taken for 52 weeks, starting on the next day of the Week 0 visit. One tablet of ropinirole PR/XR 2 mg tablets will be orally dosed as the initial dose. The dose will be titrated weekly by 2 mg/day, and increased to 8 mg/day in Week 4. From Week 5 up to 16, the dose will be increased at minimum intervals of one week between titration steps until sufficient efficacy is obtained, according to individual clinical response and tolerability (the dose may be titrated up to 16 mg/day). In Week 16 and further, treatment dose at Week 16 will be continuously administered up to Week 52. If insufficient efficacy is judged in a subject during treatment, or unable to maintain the dose due to adverse event, the treatment dose may be changed. The dose is down tapered according to the maintenance dose at Week 52 (or withdrawal).
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are diagnosed with PD with severity of the Modified Hoehn & Yahr staging at Stage I to III. * Age: 20 years or older (at the time of giving informed consent) * Gender: male and female * Both inpatient and outpatient status * 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 one's own) * Limited prior exposure to low or moderate doses of L-dopa (up to 3 months in total) or dopamine agonists (up to 6 months in total) provided treatment is discontinued for a minimum of 4 weeks prior to screening.
Exclusion criteria
* Patients who present serious physical signs and symptoms other than those of the PD (e.g. cardiac/hepatic/renal disorder and haematopoietic disorder). The seriousness refers to Grade 3 according to the Classification of the Severity of Adverse Experiences (Pharmaceutical affairs bureau/Safety division (PAB/SD) Notification No. 80, dated 29 June 1992). * Patients with symptomatic postural hypotension. (e.g. dizziness and syncope). * Patients who have had serious psychiatric symptoms (e.g. confusion, hallucination, delusion, abnormal behaviour, alcohol or drug dependence) during the past six months (26 weeks) (including symptoms caused by anti-Parkinson drugs). * Patients who have been treated with the following drugs at Week -4, and whose treatment regimen of the drug has been changed from Week -4 to Week 0. * Anticholinergic agents: trihexyphenidyl hydrochloride (e.g. Artane®), piroheptine hydrochloride (Trimol®), mazaticol hydrochloride (Pentona®), metixene hydrochloride (Cholinfall®), biperiden hydrochloride (Akineton®), profenamine (Parkin®) * amantadine hydrochloride (e.g. Symmetrel®) * droxidopa (Dops®) * citicoline (e.g. Nicholin®) * selegiline hydrochloride (FP®) * zonisamide * estrogen: estriol (e.g.Estriel®) * CYP1A2 inhibitors: Ciprofloxacin HCl (e.g. Ciproxan®, enoxacin and fluvoxamine) * Patients with severe dementia such as score 3 or 4 of the UPDRS Part I (Mentation, behaviour, and mood) * 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. * Patients with current history or complication of carcinoma or malignant tumour. * Patients who have history of drug allergy to ropinirole hydrochloride (HCl). * Patients who have received surgical treatment for PD in the past (e.g. pallidectomy, deep brain stimulation). * Patients who have been treated with any other investigational drug within 12weeks prior to the treatment phase. * Others whom the investigator (sub investigator) considers ineligible for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites | Weeks 5-16 | The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. Cmax: maximum concentration, Cmin: trough plasma concentration. |
| Food Effects on AUC0-24 of SKF101468 (Ropinirole) and Its Metabolites | Weeks 5-16 | The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours (hr) post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. AUC0-24: area under the drug concentration 24 hr curve. |
| Food Effects on Tmax of SKF101468 (Ropinirole) and Its Metabolites | Weeks 5-16 | The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. Tmax: time of maximum concentration. Data are presented as the median difference between fed and fasted states for ropinirole and each metabolite. |
| Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites | Weeks 1-16 | Blood sampling in the fixed titration phase will be performed at 24 hour post dose of the last dose of 2, 4, and 8 mg (immediately before the morning dose). Blood sampling in the maintenance dose phase will be performed at 24 hour post dose of 10 mg or more for one week or longer (immediately before the morning dose), as sampling needs to be conducted at steady state. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Score in the Japanese UPDRS Part I | Weeks 0-52 | The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per each item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms. |
| Urinalysis Data | Screening, Week 16, and Week 52 | The number of participants with the indicated dipstick test values were measured. Dipstick test values: Neg Value, Trace, +1, +2, +3, +4. No participants had a score of +5. |
| Change From Baseline in the Japanese UPDRS Part I | Baseline (Week 0) and Weeks 1-52 | The UPDRS (Unified Parkinson's Disease Rating Scale) assesses the status of PD patients objectively. The Japanese UPDRS Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per each item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms. |
| Percent Change From Baseline in the Japanese UPDRS Part I | Baseline (Week 0) and Weeks 1-52 | The UPDRS (Unified Parkinson's Disease Rating Scale) assesses the status of PD patients objectively. The Japanese UPDRS Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per each item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms. |
| Total Score in the Japanese UPDRS Part II | Weeks 0-52 | The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per each item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. |
| Change From Baseline in the Japanese UPDRS Part II | Baseline (Week 0) and Weeks 1-52 | The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per each item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. |
| Percent Change From Baseline in the Japanese UPDRS Part II | Baseline (Week 0) and Weeks 1-52 | The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per each item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. |
| Total Score in the Japanese UPDRS Part IV | Baseline (Week 0) and Weeks 0-52 | The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per each item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. |
| Change From Baseline in the Japanese UPDRS Part IV | Baseline (Week 0) and Weeks 1-52 | The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per each item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. |
| Percent Change From Baseline in the Japanese UPDRS Part IV | Baseline (Week 0) and Weeks 1-52 | The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per each item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. |
| Summary of the Modified Hoehn & Yahr Criteria Stages | Screening-Week 52 | Hoehn & Yahr criteria were measured on an 8-point scale. 0: No signs of disease, 1: Unilateral disease, 1.5: Unilateral plus axial involvement, 2: Bilateral disease, 2.5: Mild bilateral disease, 3: Mild to moderate bilateral disease. No subjects evaluated had a score of 4 (severe disability) or 5 (wheelchair bound or bedridden unless aided). |
| Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale | Weeks 1-52 | CGI is measured on a 7-point scale. 1: Very much improved, 2: Much Improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse. Responders are defined as those participants scored as very much improved or much improved. |
| Total Score in the Japanese UPDRS Part III | Weeks 0-52 | The Unified Parkinson's Disease Rating Scale (UPDRS) assesses the status of Parkinson's Disease (PD) patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. |
| Change From Baseline in Albumin, Total Protein, and Hemoglobin at Weeks 16 and 52 | Baseline (Screening) and Weeks 16 and 52 | Change from baseline was calculated as the Week 16 and 52 values minus the baseline values. |
| Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52 | Baseline (Screening) and Weeks 16 and 52 | Change from baseline was calculated as the Week 16 and 52 values minus the baseline values. |
| Change From Baseline in Total Bilirubin, Blood Urea Nitrogen, and Creatinine at Weeks 16 and 52 | Baseline (Screening) and Weeks 16 and 52 | Change from baseline was calculated as the Week 16 and 52 values minus the baseline values. |
| Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52 | Baseline (Screening) and Weeks 16 and 52 | Change from baseline was calculated as the Week 16 and 52 values minus the baseline values. |
| Change From Baseline in Prolactin at Weeks 16 and 52 | Baseline (Screening) and Weeks 16 and 52 | Change from baseline was calculated as the Week 16 and 52 values minus the baseline values. |
| Change From Baseline in Hematocrit at Weeks 16 and 52 | Baseline (Screening) and Weeks 16 and 52 | Change from baseline was calculated as the Week 16 and 52 values minus the baseline values. |
| Change From Baseline in Platelet Count and White Blood Cell Count at Weeks 16 and 52 | Baseline (Screening) and Weeks 16 and 52 | Change from baseline was calculated as the Week 16 and 52 values minus the baseline values. |
| Change From Baseline in Red Blood Cell Count at Weeks 16 and 52 | Baseline (Screening) and Weeks 16 and 52 | Change from baseline was calculated as the Week 16 and 52 values minus the baseline values. |
| Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 | Baseline (Screening) and Weeks 16 and 52 | Baseline Finding/Time Period Finding. Abbreviations: N = normal; A = abnormal; CS = clinically significant; NCS = not clinically significant. Options include N/N, N/ANCS, N/ACS, ANCS/N, ANCS/ANCS, ANCS/ACS, ACS/N, ACS/ANCS, and ACS/ACS. |
| Change From Baseline in Supine and Standing Systolic and Diastolic Blood Pressure at Weeks 16 and 52 | Baseline (Screening) and Weeks 16 and 52 | Change from baseline was calculated as Week 16 and Week 52 values minus baseline values. |
| Change From Baseline in Supine and Standing Pulse Rate at Weeks 16 and 52 | Baseline (Screening) and Weeks 16 and 52 | Change from baseline was calculated as Week 16 and Week 52 values minus baseline values. |
| Percentage of Participants Who Remained in the Study on the Indicated Days | Days 0-364 | The percentage of participants remaining in the study was examined using the Kaplan-Meier method, in which a premature discontinuation will be considered as an event. |
| Change From Baseline in the Japanese UPDRS Part III | Baseline (Week 0) and Weeks 1-52 | The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. |
| Percent Change From Baseline in the Japanese UPDRS Part III | Baseline (Week 0) and Weeks 1-52 | The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. A maximum total score is 108 points.The higher score indicates more severe PD symptoms. |
| Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III | Baseline (Week 0) and Weeks 1-52 | A responder is defined as a participant with a 30% or more reduction at baseline. The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ropinirole PR/XR Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal) | 62 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 14 |
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Ropinirole PR/XR |
|---|---|
| Age, Continuous | 67.2 years STANDARD_DEVIATION 8.05 |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 62 participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 51 / 62 | 0 / 62 |
| serious Total, serious adverse events | 5 / 62 | 1 / 62 |
Outcome results
Primary
Food Effects on AUC0-24 of SKF101468 (Ropinirole) and Its Metabolites
The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours (hr) post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. AUC0-24: area under the drug concentration 24 hr curve.
Time frame: Weeks 5-16
Population: PK Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Ropinirole PR/XR | Food Effects on AUC0-24 of SKF101468 (Ropinirole) and Its Metabolites | SKF101468 (ropinirole), fed | 27206.103 hours*pg/mL |
| Ropinirole PR/XR | Food Effects on AUC0-24 of SKF101468 (Ropinirole) and Its Metabolites | SKF101468 (ropinirole), fasted | 27191.804 hours*pg/mL |
| Ropinirole PR/XR | Food Effects on AUC0-24 of SKF101468 (Ropinirole) and Its Metabolites | SKF104557 (metabolite), fed | 23090.150 hours*pg/mL |
| Ropinirole PR/XR | Food Effects on AUC0-24 of SKF101468 (Ropinirole) and Its Metabolites | SKF104557 (metabolite), fasted | 24478.797 hours*pg/mL |
| Ropinirole PR/XR | Food Effects on AUC0-24 of SKF101468 (Ropinirole) and Its Metabolites | SKF89124 (metabolite), fed | 1044.877 hours*pg/mL |
| Ropinirole PR/XR | Food Effects on AUC0-24 of SKF101468 (Ropinirole) and Its Metabolites | SKF89124 (metabolite), fasted | 1092.635 hours*pg/mL |
Primary
Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites
The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. Cmax: maximum concentration, Cmin: trough plasma concentration.
Time frame: Weeks 5-16
Population: Pharmacokinetic (PK) Population: participants who underwent blood sampling for PK research, excluding those who did not fulfill inclusion criteria and those who were considered to affect the evaluation of the PK research due to drug incompliance or other protocol violation.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Ropinirole PR/XR | Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites | SKF101468 (ropinirole), Cmax, fed | 1563.784 picograms/milliliter (pg/mL) |
| Ropinirole PR/XR | Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites | SKF101468 (ropinirole), Cmax, fasted | 1542.182 picograms/milliliter (pg/mL) |
| Ropinirole PR/XR | Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites | SKF101468 (ropinirole), Cmin, fed | 728.404 picograms/milliliter (pg/mL) |
| Ropinirole PR/XR | Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites | SKF101468 (ropinirole), Cmin, fasted | 725.103 picograms/milliliter (pg/mL) |
| Ropinirole PR/XR | Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites | SKF104557 (metabolite), Cmax, fed | 1159.120 picograms/milliliter (pg/mL) |
| Ropinirole PR/XR | Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites | SKF104557 (metabolite), Cmax, fasted | 1250.554 picograms/milliliter (pg/mL) |
| Ropinirole PR/XR | Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites | SKF104557 (metabolite), Cmin, fed | 798.871 picograms/milliliter (pg/mL) |
| Ropinirole PR/XR | Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites | SKF104557 (metabolite), Cmin, fasted | 786.097 picograms/milliliter (pg/mL) |
| Ropinirole PR/XR | Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites | SKF89124 (metabolite), Cmax, fed | 55.282 picograms/milliliter (pg/mL) |
| Ropinirole PR/XR | Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites | SKF89124 (metabolite), Cmax, fasted | 60.742 picograms/milliliter (pg/mL) |
| Ropinirole PR/XR | Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites | SKF89124 (metabolite), Cmin, fed | 34.281 picograms/milliliter (pg/mL) |
| Ropinirole PR/XR | Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites | SKF89124 (metabolite), Cmin, fasted | 34.599 picograms/milliliter (pg/mL) |
Primary
Food Effects on Tmax of SKF101468 (Ropinirole) and Its Metabolites
The dose of SKF101468 and its metabolites was normalized to 1 mg. Blood sampling at steady state up to 24 hours post dose after receiving the maintenance dose was conducted. In order to investigate the effect of a meal on pharmacokinetics, blood was sampled twice (after a standard morning meal and at fasted state) from identical participants. Tmax: time of maximum concentration. Data are presented as the median difference between fed and fasted states for ropinirole and each metabolite.
Time frame: Weeks 5-16
Population: PK Population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ropinirole PR/XR | Food Effects on Tmax of SKF101468 (Ropinirole) and Its Metabolites | SKF101468 (ropinirole) | 2.000 hours |
| Ropinirole PR/XR | Food Effects on Tmax of SKF101468 (Ropinirole) and Its Metabolites | SKF104557 (metabolite) | 3.983 hours |
| Ropinirole PR/XR | Food Effects on Tmax of SKF101468 (Ropinirole) and Its Metabolites | SKF89124 (metabolite) | 1.000 hours |
Primary
Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites
Blood sampling in the fixed titration phase will be performed at 24 hour post dose of the last dose of 2, 4, and 8 mg (immediately before the morning dose). Blood sampling in the maintenance dose phase will be performed at 24 hour post dose of 10 mg or more for one week or longer (immediately before the morning dose), as sampling needs to be conducted at steady state.
Time frame: Weeks 1-16
Population: PK Population. Blood sampling was performed in all participants in the Fixed titration phase and Maintenance dose phase to measure trough concentration. The maintenance dose differs for individual participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole PR/XR | Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites | SKF101468 (ropinirole), 12 mg, n=12 | 11971.49 pg/mL | Standard Deviation 7211.987 |
| Ropinirole PR/XR | Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites | SKF104557 (metabolite), 14 mg, n=9 | 11579.79 pg/mL | Standard Deviation 4279.464 |
| Ropinirole PR/XR | Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites | SKF101468 (ropinirole), 8 mg, n=61 | 7598.90 pg/mL | Standard Deviation 5512.105 |
| Ropinirole PR/XR | Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites | SKF101468 (ropinirole), 10 mg, n=17 | 9772.23 pg/mL | Standard Deviation 3237.589 |
| Ropinirole PR/XR | Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites | SKF101468 (ropinirole), 14 mg, n=9 | 12575.41 pg/mL | Standard Deviation 5586.121 |
| Ropinirole PR/XR | Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites | SKF101468 (ropinirole), 16 mg, n=12 | 15467.01 pg/mL | Standard Deviation 8292.375 |
| Ropinirole PR/XR | Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites | SKF104557 (metabolite), 2 mg, n=61 | 1564.52 pg/mL | Standard Deviation 777.387 |
| Ropinirole PR/XR | Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites | SKF104557 (metabolite), 4 mg, n=58 | 3224.53 pg/mL | Standard Deviation 1184.861 |
| Ropinirole PR/XR | Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites | SKF104557 (metabolite), 6 mg, n=1 | 4172.10 pg/mL | Standard Deviation 0 |
| Ropinirole PR/XR | Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites | SKF104557 (metabolite), 8 mg, n=61 | 6353.30 pg/mL | Standard Deviation 2173.457 |
| Ropinirole PR/XR | Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites | SKF104557 (metabolite), 10 mg, n=17 | 7944.70 pg/mL | Standard Deviation 1887.958 |
| Ropinirole PR/XR | Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites | SKF104557 (metabolite), 12 mg, n=12 | 11814.28 pg/mL | Standard Deviation 3917.886 |
| Ropinirole PR/XR | Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites | SKF104557 (metabolite), 16 mg, n=12 | 12753.83 pg/mL | Standard Deviation 2527.639 |
| Ropinirole PR/XR | Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites | SKF89124 (metabolite), 2 mg, n=61 | 66.14 pg/mL | Standard Deviation 39.824 |
| Ropinirole PR/XR | Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites | SKF89124 (metabolite), 4 mg, n=58 | 139.84 pg/mL | Standard Deviation 56.099 |
| Ropinirole PR/XR | Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites | SKF89124 (metabolite), 6 mg, n=1 | 157.40 pg/mL | Standard Deviation 0 |
| Ropinirole PR/XR | Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites | SKF89124 (metabolite), 8 mg, n=61 | 281.36 pg/mL | Standard Deviation 120.381 |
| Ropinirole PR/XR | Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites | SKF89124 (metabolite), 10 mg, n=17 | 318.82 pg/mL | Standard Deviation 83.774 |
| Ropinirole PR/XR | Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites | SKF89124 (metabolite), 12 mg, n=12 | 479.36 pg/mL | Standard Deviation 189.388 |
| Ropinirole PR/XR | Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites | SKF89124 (metabolite), 14 mg, n=9 | 564.57 pg/mL | Standard Deviation 286.257 |
| Ropinirole PR/XR | Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites | SKF89124 (metabolite), 16 mg, n=12 | 628.76 pg/mL | Standard Deviation 271.495 |
| Ropinirole PR/XR | Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites | SKF101468 (ropinirole), 2 mg, n=61 | 1804.87 pg/mL | Standard Deviation 1757.062 |
| Ropinirole PR/XR | Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites | SKF101468 (ropinirole), 4 mg, n=58 | 3529.59 pg/mL | Standard Deviation 1746.855 |
| Ropinirole PR/XR | Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites | SKF101468 (ropinirole), 6 mg, n=1 | 3820.20 pg/mL | Standard Deviation 0 |
Secondary
Change From Baseline in Albumin, Total Protein, and Hemoglobin at Weeks 16 and 52
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
Time frame: Baseline (Screening) and Weeks 16 and 52
Population: Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward \[LOCF\]) = 62 participants; Week 52 (Observed case \[OC\]) = 44 participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole PR/XR | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Weeks 16 and 52 | Albumin, Week 16 | -0.66 grams per Liter (G/L) | Standard Deviation 1.983 |
| Ropinirole PR/XR | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Weeks 16 and 52 | Albumin, Week 52 | -1.68 grams per Liter (G/L) | Standard Deviation 2.428 |
| Ropinirole PR/XR | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Weeks 16 and 52 | Total Protein, Week 16 | -1.71 grams per Liter (G/L) | Standard Deviation 3.761 |
| Ropinirole PR/XR | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Weeks 16 and 52 | Total Protein, Week 52 | -2.32 grams per Liter (G/L) | Standard Deviation 3.665 |
| Ropinirole PR/XR | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Weeks 16 and 52 | Hemoglobin, Week 16 | -4.44 grams per Liter (G/L) | Standard Deviation 9.557 |
| Ropinirole PR/XR | Change From Baseline in Albumin, Total Protein, and Hemoglobin at Weeks 16 and 52 | Hemoglobin, Week 52 | -4.00 grams per Liter (G/L) | Standard Deviation 11.477 |
Secondary
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
Time frame: Baseline (Screening) and Weeks 16 and 52
Population: Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward \[LOCF\]) = 62 participants; Week 52 (Observed case \[OC\]) = 44 participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole PR/XR | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52 | Alanine Amino Transferase, Week 52 | 2.3 international units per Liter (IU/L) | Standard Deviation 13.34 |
| Ropinirole PR/XR | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52 | Aspartate Amino Transferase, Week 16 | 0.3 international units per Liter (IU/L) | Standard Deviation 6.71 |
| Ropinirole PR/XR | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52 | Aspartate Amino Transferase, Week 52 | 2.0 international units per Liter (IU/L) | Standard Deviation 9.14 |
| Ropinirole PR/XR | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52 | Creatine Kinase, Week 16 | 5.7 international units per Liter (IU/L) | Standard Deviation 117.47 |
| Ropinirole PR/XR | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52 | Creatine Kinase, Week 52 | 44.0 international units per Liter (IU/L) | Standard Deviation 142.26 |
| Ropinirole PR/XR | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52 | Gamma Glutamyl transferase, Week 16 | -0.2 international units per Liter (IU/L) | Standard Deviation 21.6 |
| Ropinirole PR/XR | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52 | Gamma Glutamyl transferase, Week 52 | -3.6 international units per Liter (IU/L) | Standard Deviation 28.47 |
| Ropinirole PR/XR | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52 | Lactate Dehydrogenase, Week 16 | -2.9 international units per Liter (IU/L) | Standard Deviation 28.59 |
| Ropinirole PR/XR | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52 | Lactate Dehydrogenase, Week 52 | 8.7 international units per Liter (IU/L) | Standard Deviation 34.25 |
| Ropinirole PR/XR | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52 | Alkaline Phosphatase, Week 16 | 16.5 international units per Liter (IU/L) | Standard Deviation 47.25 |
| Ropinirole PR/XR | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52 | Alkaline Phosphatase, Week 52 | 2.5 international units per Liter (IU/L) | Standard Deviation 37.78 |
| Ropinirole PR/XR | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Weeks 16 and 52 | Alanine Amino Transferase, Week 16 | 1.1 international units per Liter (IU/L) | Standard Deviation 9.34 |
Secondary
Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
Time frame: Baseline (Screening) and Weeks 16 and 52
Population: Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward \[LOCF\]) = 62 participants; Week 52 (Observed case \[OC\]) = 44 participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole PR/XR | Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52 | Blood Urea Nitrogen, Week 16 | 0.02 millimoles per Liter (MMOL/L) | Standard Deviation 1.448 |
| Ropinirole PR/XR | Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52 | Blood Urea Nitrogen, Week 52 | 0.19 millimoles per Liter (MMOL/L) | Standard Deviation 1.512 |
| Ropinirole PR/XR | Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52 | Cholesterol, Week 16 | -0.3 millimoles per Liter (MMOL/L) | Standard Deviation 0.65 |
| Ropinirole PR/XR | Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52 | Cholesterol, Week 52 | -0.3 millimoles per Liter (MMOL/L) | Standard Deviation 0.59 |
| Ropinirole PR/XR | Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52 | Chloride, Week 16 | -0.1 millimoles per Liter (MMOL/L) | Standard Deviation 2.62 |
| Ropinirole PR/XR | Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52 | Chloride, Week 52 | 0.4 millimoles per Liter (MMOL/L) | Standard Deviation 2.13 |
| Ropinirole PR/XR | Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52 | Potassium, Week 16 | -0.01 millimoles per Liter (MMOL/L) | Standard Deviation 0.334 |
| Ropinirole PR/XR | Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52 | Potassium, Week 52 | -0.03 millimoles per Liter (MMOL/L) | Standard Deviation 0.378 |
| Ropinirole PR/XR | Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52 | Sodium, Week 16 | -0.1 millimoles per Liter (MMOL/L) | Standard Deviation 2.46 |
| Ropinirole PR/XR | Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52 | Sodium, Week 52 | -0.1 millimoles per Liter (MMOL/L) | Standard Deviation 1.92 |
Secondary
Change From Baseline in Hematocrit at Weeks 16 and 52
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
Time frame: Baseline (Screening) and Weeks 16 and 52
Population: Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward \[LOCF\]) = 62 participants; Week 52 (Observed case \[OC\]) = 44 participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole PR/XR | Change From Baseline in Hematocrit at Weeks 16 and 52 | Week 16 | -0.01 proportion of 1 (SI) | Standard Deviation 0.028 |
| Ropinirole PR/XR | Change From Baseline in Hematocrit at Weeks 16 and 52 | Week 52 | -0.01 proportion of 1 (SI) | Standard Deviation 0.028 |
Secondary
Change From Baseline in Platelet Count and White Blood Cell Count at Weeks 16 and 52
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
Time frame: Baseline (Screening) and Weeks 16 and 52
Population: Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward \[LOCF\]) = 62 participants; Week 52 (Observed case \[OC\]) = 44 participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole PR/XR | Change From Baseline in Platelet Count and White Blood Cell Count at Weeks 16 and 52 | Platelet count, Week 16 | -6.81 giga per Liter (GI/L) | Standard Deviation 31.618 |
| Ropinirole PR/XR | Change From Baseline in Platelet Count and White Blood Cell Count at Weeks 16 and 52 | Platelet count, Week 52 | -8.07 giga per Liter (GI/L) | Standard Deviation 44.229 |
| Ropinirole PR/XR | Change From Baseline in Platelet Count and White Blood Cell Count at Weeks 16 and 52 | White Blood Cell Count, Week 16 | -0.6 giga per Liter (GI/L) | Standard Deviation 1.3 |
| Ropinirole PR/XR | Change From Baseline in Platelet Count and White Blood Cell Count at Weeks 16 and 52 | White Blood Cell Count, Week 52 | -0.5 giga per Liter (GI/L) | Standard Deviation 1.1 |
Secondary
Change From Baseline in Prolactin at Weeks 16 and 52
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
Time frame: Baseline (Screening) and Weeks 16 and 52
Population: Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward \[LOCF\]) = 62 participants; Week 52 (Observed case \[OC\]) = 44 participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole PR/XR | Change From Baseline in Prolactin at Weeks 16 and 52 | Week 16 | -7.22 micrograms per Liter (MCG/L) | Standard Deviation 7.132 |
| Ropinirole PR/XR | Change From Baseline in Prolactin at Weeks 16 and 52 | Week 52 | -8.18 micrograms per Liter (MCG/L) | Standard Deviation 2.495 |
Secondary
Change From Baseline in Red Blood Cell Count at Weeks 16 and 52
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
Time frame: Baseline (Screening) and Weeks 16 and 52
Population: Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward \[LOCF\]) = 62 participants; Week 52 (Observed case \[OC\]) = 44 participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole PR/XR | Change From Baseline in Red Blood Cell Count at Weeks 16 and 52 | Week 16 | -0.1 tera per Liter (TI/L) | Standard Deviation 0.26 |
| Ropinirole PR/XR | Change From Baseline in Red Blood Cell Count at Weeks 16 and 52 | Week 52 | -0.2 tera per Liter (TI/L) | Standard Deviation 0.27 |
Secondary
Change From Baseline in Supine and Standing Pulse Rate at Weeks 16 and 52
Change from baseline was calculated as Week 16 and Week 52 values minus baseline values.
Time frame: Baseline (Screening) and Weeks 16 and 52
Population: Safety Population: Week 16 (LOCF) = 62 participants; Week 52 (OC) = 44 participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole PR/XR | Change From Baseline in Supine and Standing Pulse Rate at Weeks 16 and 52 | Supine Heart Rate - Week 16 | 0.2 beats per minute (bpm) | Standard Deviation 9.13 |
| Ropinirole PR/XR | Change From Baseline in Supine and Standing Pulse Rate at Weeks 16 and 52 | Supine Heart Rate - Week 52 | -2.3 beats per minute (bpm) | Standard Deviation 11.22 |
| Ropinirole PR/XR | Change From Baseline in Supine and Standing Pulse Rate at Weeks 16 and 52 | Standing Heart Rate - Week 16 | 0.2 beats per minute (bpm) | Standard Deviation 10.32 |
| Ropinirole PR/XR | Change From Baseline in Supine and Standing Pulse Rate at Weeks 16 and 52 | Standing Heart Rate - Week 52 | 0.0 beats per minute (bpm) | Standard Deviation 9.43 |
Secondary
Change From Baseline in Supine and Standing Systolic and Diastolic Blood Pressure at Weeks 16 and 52
Change from baseline was calculated as Week 16 and Week 52 values minus baseline values.
Time frame: Baseline (Screening) and Weeks 16 and 52
Population: Safety Population: Week 16 (LOCF) = 62 participants; Week 52 (OC) = 44 participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole PR/XR | Change From Baseline in Supine and Standing Systolic and Diastolic Blood Pressure at Weeks 16 and 52 | Supine Systolic BP - Week 16 | -0.0 millimeters of mercury (mmHg) | Standard Deviation 20.54 |
| Ropinirole PR/XR | Change From Baseline in Supine and Standing Systolic and Diastolic Blood Pressure at Weeks 16 and 52 | Supine Systolic BP - Week 52 | -1.2 millimeters of mercury (mmHg) | Standard Deviation 22.84 |
| Ropinirole PR/XR | Change From Baseline in Supine and Standing Systolic and Diastolic Blood Pressure at Weeks 16 and 52 | Supine Diastolic BP - Week 16 | 0.6 millimeters of mercury (mmHg) | Standard Deviation 11.57 |
| Ropinirole PR/XR | Change From Baseline in Supine and Standing Systolic and Diastolic Blood Pressure at Weeks 16 and 52 | Supine Diastolic BP - Week 52 | -1.2 millimeters of mercury (mmHg) | Standard Deviation 12.06 |
| Ropinirole PR/XR | Change From Baseline in Supine and Standing Systolic and Diastolic Blood Pressure at Weeks 16 and 52 | Standing Systolic BP - Week 16 | -0.7 millimeters of mercury (mmHg) | Standard Deviation 19.77 |
| Ropinirole PR/XR | Change From Baseline in Supine and Standing Systolic and Diastolic Blood Pressure at Weeks 16 and 52 | Standing Systolic BP - Week 52 | 0.0 millimeters of mercury (mmHg) | Standard Deviation 19.08 |
| Ropinirole PR/XR | Change From Baseline in Supine and Standing Systolic and Diastolic Blood Pressure at Weeks 16 and 52 | Standing Diastolic BP - Week 16 | -0.7 millimeters of mercury (mmHg) | Standard Deviation 12.93 |
| Ropinirole PR/XR | Change From Baseline in Supine and Standing Systolic and Diastolic Blood Pressure at Weeks 16 and 52 | Standing Diastolic BP - Week 52 | 2.1 millimeters of mercury (mmHg) | Standard Deviation 12.17 |
Secondary
Change From Baseline in the Japanese UPDRS Part I
The UPDRS (Unified Parkinson's Disease Rating Scale) assesses the status of PD patients objectively. The Japanese UPDRS Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per each item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.
Time frame: Baseline (Week 0) and Weeks 1-52
Population: FAS. Participants dropped out of the study each week.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part I | Week 1, n=62 | -0.3 points on a scale | Standard Deviation 1 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part I | Week 2, n=60 | -0.5 points on a scale | Standard Deviation 0.91 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part I | Week 3, n=60 | -0.5 points on a scale | Standard Deviation 1.14 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part I | Week 4, n=58 | -0.5 points on a scale | Standard Deviation 1.13 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part I | Week 6, n=57 | -0.5 points on a scale | Standard Deviation 1.21 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part I | Week 8, n=56 | -0.5 points on a scale | Standard Deviation 1.16 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part I | Week 10, n=57 | -0.3 points on a scale | Standard Deviation 1.21 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part I | Week 12, n=56 | -0.5 points on a scale | Standard Deviation 1.14 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part I | Week 16, n=54 | -0.6 points on a scale | Standard Deviation 1.24 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part I | Final Assessment Point (Up to Week 16), n=62 | -0.5 points on a scale | Standard Deviation 1.21 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part I | Week 20, n=53 | -0.5 points on a scale | Standard Deviation 1.15 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part I | Week 24, n=51 | -0.5 points on a scale | Standard Deviation 1.1 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part I | Week 28, n=48 | -0.5 points on a scale | Standard Deviation 1.11 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part I | Week 32, n=47 | -0.5 points on a scale | Standard Deviation 1.2 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part I | Week 36, n=47 | -0.4 points on a scale | Standard Deviation 1.28 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part I | Week 40, n=45 | -0.4 points on a scale | Standard Deviation 1.16 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part I | Week 44, n=45 | -0.4 points on a scale | Standard Deviation 1.25 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part I | Week 48, n=44 | -0.4 points on a scale | Standard Deviation 1.3 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part I | Week 52, n=44 | -0.4 points on a scale | Standard Deviation 1.3 |
Secondary
Change From Baseline in the Japanese UPDRS Part II
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per each item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.
Time frame: Baseline (Week 0) and Weeks 1-52
Population: FAS. Participants dropped out of the study each week.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part II | Week 8, n=56 | -4.2 points on a scale | Standard Deviation 3.09 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part II | Week 10, n=57 | -4.1 points on a scale | Standard Deviation 3.16 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part II | Week 12, n=56 | -4.0 points on a scale | Standard Deviation 3.2 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part II | Week 16, n=54 | -4.1 points on a scale | Standard Deviation 3.28 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part II | Week 1, n=62 | -1.0 points on a scale | Standard Deviation 1.6 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part II | Week 2, n=60 | -1.9 points on a scale | Standard Deviation 2.14 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part II | Week 3, n=60 | -2.6 points on a scale | Standard Deviation 2.44 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part II | Week 4, n=58 | -3.4 points on a scale | Standard Deviation 2.84 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part II | Week 6, n=57 | -3.7 points on a scale | Standard Deviation 2.74 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part II | Final Assessment Point (Up to Week 16), n=62 | -3.9 points on a scale | Standard Deviation 3.22 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part II | Week 20, n=53 | -4.1 points on a scale | Standard Deviation 3.5 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part II | Week 24, n=51 | -4.4 points on a scale | Standard Deviation 3.48 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part II | Week 28, n=48 | -4.0 points on a scale | Standard Deviation 3.75 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part II | Week 32, n=47 | -4.2 points on a scale | Standard Deviation 3.66 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part II | Week 36, n=47 | -4.1 points on a scale | Standard Deviation 3.8 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part II | Week 40, n=45 | -3.9 points on a scale | Standard Deviation 3.98 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part II | Week 44, n=45 | -3.8 points on a scale | Standard Deviation 3.84 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part II | Week 48, n=44 | -4.0 points on a scale | Standard Deviation 3.96 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part II | Week 52, n=44 | -3.7 points on a scale | Standard Deviation 4.42 |
Secondary
Change From Baseline in the Japanese UPDRS Part III
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.
Time frame: Baseline (Week 0) and Weeks 1-52
Population: FAS. Participants dropped out of the study each week.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part III | Week 1, n=62 | -3.1 points on a scale | Standard Deviation 4.21 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part III | Week 2, n=60 | -5.8 points on a scale | Standard Deviation 5.18 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part III | Week 3, n=60 | -7.7 points on a scale | Standard Deviation 6.67 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part III | Week 4, n=58 | -9.7 points on a scale | Standard Deviation 6.77 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part III | Week 6, n=57 | -10.5 points on a scale | Standard Deviation 7.31 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part III | Week 8, n=56 | -11.5 points on a scale | Standard Deviation 7.95 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part III | Week 10, n=57 | -12.4 points on a scale | Standard Deviation 7.57 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part III | Week 12, n=56 | -12.3 points on a scale | Standard Deviation 7.47 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part III | Week 16, n=54 | -12.2 points on a scale | Standard Deviation 8.1 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part III | Final Assessment Point (Up to Week 16), n=62 | -11.3 points on a scale | Standard Deviation 8.21 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part III | Week 20, n=53 | -12.1 points on a scale | Standard Deviation 8.65 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part III | Week 24, n=51 | -11.6 points on a scale | Standard Deviation 8.21 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part III | Week 28, n=48 | -11.5 points on a scale | Standard Deviation 9.04 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part III | Week 32, n=47 | -11.7 points on a scale | Standard Deviation 8.27 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part III | Week 36, n=47 | -11.7 points on a scale | Standard Deviation 8.37 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part III | Week 40, n=45 | -11.5 points on a scale | Standard Deviation 8.26 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part III | Week 44, n=45 | -11.2 points on a scale | Standard Deviation 9.12 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part III | Week 48, n=44 | -11.9 points on a scale | Standard Deviation 8.57 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part III | Week 52, n=44 | -11.4 points on a scale | Standard Deviation 8.55 |
Secondary
Change From Baseline in the Japanese UPDRS Part IV
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per each item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.
Time frame: Baseline (Week 0) and Weeks 1-52
Population: FAS. Participants dropped out of the study each week.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part IV | Week 48, n=44 | 0.3 points on a scale | Standard Deviation 0.72 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part IV | Week 52, n=44 | 0.2 points on a scale | Standard Deviation 0.74 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part IV | Week 1, n=62 | 0.2 points on a scale | Standard Deviation 0.64 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part IV | Week 2, n=60 | 0.4 points on a scale | Standard Deviation 0.74 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part IV | Week 3, n=60 | 0.3 points on a scale | Standard Deviation 0.74 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part IV | Week 4, n=58 | 0.3 points on a scale | Standard Deviation 0.78 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part IV | Week 6, n=57 | 0.3 points on a scale | Standard Deviation 0.83 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part IV | Week 8, n=56 | 0.2 points on a scale | Standard Deviation 0.74 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part IV | Week 10, n=57 | 0.2 points on a scale | Standard Deviation 0.7 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part IV | Week 12, n=56 | 0.2 points on a scale | Standard Deviation 0.72 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part IV | Week 16, n=54 | 0.2 points on a scale | Standard Deviation 0.63 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part IV | Final Assessment Point (Up to Week 16), n=62 | 0.2 points on a scale | Standard Deviation 0.66 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part IV | Week 20, n=53 | 0.3 points on a scale | Standard Deviation 0.67 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part IV | Week 24, n=51 | 0.2 points on a scale | Standard Deviation 0.68 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part IV | Week 28, n=48 | 0.3 points on a scale | Standard Deviation 0.75 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part IV | Week 32, n=47 | 0.2 points on a scale | Standard Deviation 0.7 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part IV | Week 36, n=47 | 0.3 points on a scale | Standard Deviation 0.71 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part IV | Week 40, n=45 | 0.1 points on a scale | Standard Deviation 0.66 |
| Ropinirole PR/XR | Change From Baseline in the Japanese UPDRS Part IV | Week 44, n=45 | 0.2 points on a scale | Standard Deviation 0.63 |
Secondary
Change From Baseline in Total Bilirubin, Blood Urea Nitrogen, and Creatinine at Weeks 16 and 52
Change from baseline was calculated as the Week 16 and 52 values minus the baseline values.
Time frame: Baseline (Screening) and Weeks 16 and 52
Population: Safety Population: all participants who received at least one dose of study medication. Week 16 (Last observation carried forward \[LOCF\]) = 62 participants; Week 52 (Observed case \[OC\]) = 44 participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole PR/XR | Change From Baseline in Total Bilirubin, Blood Urea Nitrogen, and Creatinine at Weeks 16 and 52 | Total Bilirubin, Week 16 | 0.19 micromoles per Liter (UMOL/L) | Standard Deviation 3.806 |
| Ropinirole PR/XR | Change From Baseline in Total Bilirubin, Blood Urea Nitrogen, and Creatinine at Weeks 16 and 52 | Total Bilirubin, Week 52 | 0.12 micromoles per Liter (UMOL/L) | Standard Deviation 2.429 |
| Ropinirole PR/XR | Change From Baseline in Total Bilirubin, Blood Urea Nitrogen, and Creatinine at Weeks 16 and 52 | Creatinine, Week 16 | 2.281 micromoles per Liter (UMOL/L) | Standard Deviation 6.78 |
| Ropinirole PR/XR | Change From Baseline in Total Bilirubin, Blood Urea Nitrogen, and Creatinine at Weeks 16 and 52 | Creatinine, Week 52 | 1.266 micromoles per Liter (UMOL/L) | Standard Deviation 7.763 |
Secondary
Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale
CGI is measured on a 7-point scale. 1: Very much improved, 2: Much Improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse. Responders are defined as those participants scored as very much improved or much improved.
Time frame: Weeks 1-52
Population: FAS. Participants dropped out of the study each week.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ropinirole PR/XR | Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale | Week 1, n=62 | 8 participants |
| Ropinirole PR/XR | Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale | Week 2, n=60 | 16 participants |
| Ropinirole PR/XR | Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale | Week 3, n=60 | 25 participants |
| Ropinirole PR/XR | Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale | Week 4, n=58 | 39 participants |
| Ropinirole PR/XR | Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale | Week 6, n=57 | 40 participants |
| Ropinirole PR/XR | Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale | Week 8, n=56 | 45 participants |
| Ropinirole PR/XR | Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale | Week 10, n=57 | 47 participants |
| Ropinirole PR/XR | Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale | Week 12, n=56 | 48 participants |
| Ropinirole PR/XR | Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale | Week 16, n=54 | 41 participants |
| Ropinirole PR/XR | Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale | Final Assessment Point (Up to Week 16), n=62 | 44 participants |
| Ropinirole PR/XR | Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale | Week 20, n=53 | 43 participants |
| Ropinirole PR/XR | Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale | Week 24, n=51 | 40 participants |
| Ropinirole PR/XR | Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale | Week 28, n=48 | 38 participants |
| Ropinirole PR/XR | Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale | Week 32, n=47 | 35 participants |
| Ropinirole PR/XR | Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale | Week 36, n=47 | 35 participants |
| Ropinirole PR/XR | Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale | Week 40, n=45 | 33 participants |
| Ropinirole PR/XR | Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale | Week 44, n=45 | 35 participants |
| Ropinirole PR/XR | Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale | Week 48, n=44 | 37 participants |
| Ropinirole PR/XR | Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale | Week 52, n=44 | 35 participants |
Secondary
Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52
Baseline Finding/Time Period Finding. Abbreviations: N = normal; A = abnormal; CS = clinically significant; NCS = not clinically significant. Options include N/N, N/ANCS, N/ACS, ANCS/N, ANCS/ANCS, ANCS/ACS, ACS/N, ACS/ANCS, and ACS/ACS.
Time frame: Baseline (Screening) and Weeks 16 and 52
Population: Safety Population: Week 16 (LOCF) = 62 participants; Week 52 (OC) = 44 participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ropinirole PR/XR | Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 | Baseline: N; Week 16: N | 32 participants |
| Ropinirole PR/XR | Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 | Baseline: N; Week 16: ANCS | 10 participants |
| Ropinirole PR/XR | Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 | Baseline: N; Week 16: ACS | 0 participants |
| Ropinirole PR/XR | Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 | Baseline: ANCS; Week 16: N | 5 participants |
| Ropinirole PR/XR | Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 | Baseline: ANCS; Week 16: ANCS | 13 participants |
| Ropinirole PR/XR | Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 | Baseline: ANCS; Week 16: ACS | 0 participants |
| Ropinirole PR/XR | Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 | Baseline: ACS; Week 16: N | 0 participants |
| Ropinirole PR/XR | Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 | Baseline: ACS; Week 16: ANCS | 0 participants |
| Ropinirole PR/XR | Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 | Baseline: ACS; Week 16: ACS | 2 participants |
| Ropinirole PR/XR | Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 | Baseline: N; Week 52: N | 26 participants |
| Ropinirole PR/XR | Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 | Baseline: N; Week 52: ANCS | 3 participants |
| Ropinirole PR/XR | Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 | Baseline: N; Week 52: ACS | 0 participants |
| Ropinirole PR/XR | Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 | Baseline: ANCS; Week 52: N | 5 participants |
| Ropinirole PR/XR | Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 | Baseline: ANCS; Week 52: ANCS | 9 participants |
| Ropinirole PR/XR | Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 | Baseline: ANCS; Week 52: ACS | 0 participants |
| Ropinirole PR/XR | Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 | Baseline: ACS; Week 52: N | 0 participants |
| Ropinirole PR/XR | Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 | Baseline: ACS; Week 52: ANCS | 0 participants |
| Ropinirole PR/XR | Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52 | Baseline: ACS; Week 52: ACS | 1 participants |
Secondary
Percentage of Participants Who Remained in the Study on the Indicated Days
The percentage of participants remaining in the study was examined using the Kaplan-Meier method, in which a premature discontinuation will be considered as an event.
Time frame: Days 0-364
Population: FAS. Participants dropped out of the study each week.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ropinirole PR/XR | Percentage of Participants Who Remained in the Study on the Indicated Days | Day 0 | 100 percentage of participants |
| Ropinirole PR/XR | Percentage of Participants Who Remained in the Study on the Indicated Days | Day 10 | 98 percentage of participants |
| Ropinirole PR/XR | Percentage of Participants Who Remained in the Study on the Indicated Days | Day 14 | 97 percentage of participants |
| Ropinirole PR/XR | Percentage of Participants Who Remained in the Study on the Indicated Days | Day 21 | 94 percentage of participants |
| Ropinirole PR/XR | Percentage of Participants Who Remained in the Study on the Indicated Days | Day 28 | 92 percentage of participants |
| Ropinirole PR/XR | Percentage of Participants Who Remained in the Study on the Indicated Days | Day 70 | 90 percentage of participants |
| Ropinirole PR/XR | Percentage of Participants Who Remained in the Study on the Indicated Days | Day 84 | 89 percentage of participants |
| Ropinirole PR/XR | Percentage of Participants Who Remained in the Study on the Indicated Days | Day 96 | 87 percentage of participants |
| Ropinirole PR/XR | Percentage of Participants Who Remained in the Study on the Indicated Days | Day 112 | 85 percentage of participants |
| Ropinirole PR/XR | Percentage of Participants Who Remained in the Study on the Indicated Days | Day 140 | 84 percentage of participants |
| Ropinirole PR/XR | Percentage of Participants Who Remained in the Study on the Indicated Days | Day 168 | 82 percentage of participants |
| Ropinirole PR/XR | Percentage of Participants Who Remained in the Study on the Indicated Days | Day 175 | 79 percentage of participants |
| Ropinirole PR/XR | Percentage of Participants Who Remained in the Study on the Indicated Days | Day 183 | 77 percentage of participants |
| Ropinirole PR/XR | Percentage of Participants Who Remained in the Study on the Indicated Days | Day 196 | 76 percentage of participants |
| Ropinirole PR/XR | Percentage of Participants Who Remained in the Study on the Indicated Days | Day 239 | 74 percentage of participants |
| Ropinirole PR/XR | Percentage of Participants Who Remained in the Study on the Indicated Days | Day 252 | 73 percentage of participants |
| Ropinirole PR/XR | Percentage of Participants Who Remained in the Study on the Indicated Days | Day 315 | 71 percentage of participants |
| Ropinirole PR/XR | Percentage of Participants Who Remained in the Study on the Indicated Days | Day 359 | 69 percentage of participants |
| Ropinirole PR/XR | Percentage of Participants Who Remained in the Study on the Indicated Days | Day 364 | 67 percentage of participants |
Secondary
Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III
A responder is defined as a participant with a 30% or more reduction at baseline. The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.
Time frame: Baseline (Week 0) and Weeks 1-52
Population: FAS. Participants dropped out of the study each week.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ropinirole PR/XR | Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III | Week 36, n=47 | 76.6 percentage of responders |
| Ropinirole PR/XR | Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III | Week 1, n=62 | 12.9 percentage of responders |
| Ropinirole PR/XR | Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III | Week 2, n=60 | 38.3 percentage of responders |
| Ropinirole PR/XR | Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III | Week 3, n=60 | 58.3 percentage of responders |
| Ropinirole PR/XR | Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III | Week 4, n=58 | 70.7 percentage of responders |
| Ropinirole PR/XR | Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III | Week 6, n=57 | 71.9 percentage of responders |
| Ropinirole PR/XR | Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III | Week 8, n=56 | 82.1 percentage of responders |
| Ropinirole PR/XR | Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III | Week 10, n=57 | 84.2 percentage of responders |
| Ropinirole PR/XR | Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III | Week 12, n=56 | 89.3 percentage of responders |
| Ropinirole PR/XR | Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III | Week 16, n=54 | 81.5 percentage of responders |
| Ropinirole PR/XR | Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III | Final Assessment Point (Up to Week 16), n=62 | 75.8 percentage of responders |
| Ropinirole PR/XR | Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III | Week 20, n=53 | 81.1 percentage of responders |
| Ropinirole PR/XR | Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III | Week 24, n=51 | 78.4 percentage of responders |
| Ropinirole PR/XR | Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III | Week 28, n=48 | 79.2 percentage of responders |
| Ropinirole PR/XR | Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III | Week 32, n=47 | 76.6 percentage of responders |
| Ropinirole PR/XR | Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III | Week 40, n=45 | 77.8 percentage of responders |
| Ropinirole PR/XR | Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III | Week 44, n=45 | 77.8 percentage of responders |
| Ropinirole PR/XR | Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III | Week 48, n=44 | 81.8 percentage of responders |
| Ropinirole PR/XR | Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III | Week 52, n=44 | 81.8 percentage of responders |
Secondary
Percent Change From Baseline in the Japanese UPDRS Part I
The UPDRS (Unified Parkinson's Disease Rating Scale) assesses the status of PD patients objectively. The Japanese UPDRS Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per each item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.
Time frame: Baseline (Week 0) and Weeks 1-52
Population: FAS. Participants dropped out of the study each week.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part I | Final Assessment Point (Up to Week 16), n=30 | -68.89 percent change | Standard Deviation 52.838 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part I | Week 1, n=30 | -34.17 percent change | Standard Deviation 48.46 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part I | Week 2, n=29 | -54.60 percent change | Standard Deviation 46.269 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part I | Week 3, n=29 | -63.79 percent change | Standard Deviation 49.815 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part I | Week 4, n=28 | -60.71 percent change | Standard Deviation 49.735 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part I | Week 6, n=27 | -69.44 percent change | Standard Deviation 48.205 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part I | Week 8, n=27 | -54.94 percent change | Standard Deviation 59.524 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part I | Week 10, n=27 | -48.46 percent change | Standard Deviation 66.105 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part I | Week 12, n=26 | -62.50 percent change | Standard Deviation 67.956 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part I | Week 16, n=24 | -77.08 percent change | Standard Deviation 48.358 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part I | Week 20, n=23 | -71.74 percent change | Standard Deviation 51.354 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part I | Week 24, n=22 | -65.91 percent change | Standard Deviation 44.089 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part I | Week 28, n=20 | -71.67 percent change | Standard Deviation 50.466 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part I | Week 32, n=19 | -67.54 percent change | Standard Deviation 71.465 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part I | Week 36, n=19 | -55.26 percent change | Standard Deviation 66.447 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part I | Week 40, n=17 | -69.61 percent change | Standard Deviation 55.664 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part I | Week 44, n=17 | -52.94 percent change | Standard Deviation 69.531 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part I | Week 48, n=16 | -59.38 percent change | Standard Deviation 71.224 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part I | Week 52, n=16 | -53.13 percent change | Standard Deviation 71.807 |
Secondary
Percent Change From Baseline in the Japanese UPDRS Part II
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per each item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.
Time frame: Baseline (Week 0) and Weeks 1-52
Population: FAS. Participants dropped out of the study each week.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part II | Week 2, n=58 | -23.04 percent change | Standard Deviation 26.252 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part II | Week 3, n=58 | -33.09 percent change | Standard Deviation 26.531 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part II | Week 12, n=54 | -51.51 percent change | Standard Deviation 31.572 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part II | Week 16, n=52 | -50.78 percent change | Standard Deviation 35.826 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part II | Week 1, n=60 | -11.01 percent change | Standard Deviation 20.504 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part II | Week 4, n=56 | -44.30 percent change | Standard Deviation 28.348 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part II | Week 6, n=55 | -48.89 percent change | Standard Deviation 28.058 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part II | Week 8, n=54 | -53.88 percent change | Standard Deviation 29.274 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part II | Week 10, n=55 | -52.52 percent change | Standard Deviation 35.133 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part II | Final Assessment Point (Up to Week 16), n=60 | -49.03 percent change | Standard Deviation 35.664 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part II | Week 20, n=51 | -50.10 percent change | Standard Deviation 35.694 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part II | Week 24, n=49 | -54.29 percent change | Standard Deviation 31.096 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part II | Week 28, n=46 | -51.15 percent change | Standard Deviation 35.62 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part II | Week 32, n=45 | -50.91 percent change | Standard Deviation 37.745 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part II | Week 36, n=45 | -51.05 percent change | Standard Deviation 35.493 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part II | Week 40, n=43 | -48.31 percent change | Standard Deviation 41.477 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part II | Week 44, n=43 | -47.48 percent change | Standard Deviation 40.194 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part II | Week 48, n=42 | -49.28 percent change | Standard Deviation 38.285 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part II | Week 52, n=42 | -41.48 percent change | Standard Deviation 48.287 |
Secondary
Percent Change From Baseline in the Japanese UPDRS Part III
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. A maximum total score is 108 points.The higher score indicates more severe PD symptoms.
Time frame: Baseline (Week 0) and Weeks 1-52
Population: FAS. Participants dropped out of the study each week.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part III | Week 1, n=62 | -14.14 percent change | Standard Deviation 17.734 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part III | Week 2, n=60 | -27.14 percent change | Standard Deviation 23.525 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part III | Week 3, n=60 | -35.13 percent change | Standard Deviation 28.125 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part III | Week 4, n=58 | -45.03 percent change | Standard Deviation 24.055 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part III | Week 6, n=57 | -48.35 percent change | Standard Deviation 26.605 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part III | Week 8, n=56 | -51.34 percent change | Standard Deviation 30.203 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part III | Week 10, n=57 | -56.63 percent change | Standard Deviation 26.249 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part III | Week 12, n=56 | -56.24 percent change | Standard Deviation 23.382 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part III | Week 16, n=54 | -53.78 percent change | Standard Deviation 28.309 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part III | Final Assessment Point (Up to Week 16), n=62 | -49.38 percent change | Standard Deviation 32.041 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part III | Week 20, n=53 | -52.61 percent change | Standard Deviation 32.017 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part III | Week 24, n=51 | -51.56 percent change | Standard Deviation 28.676 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part III | Week 28, n=48 | -50.25 percent change | Standard Deviation 30.813 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part III | Week 32, n=47 | -51.67 percent change | Standard Deviation 26.037 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part III | Week 36, n=47 | -51.36 percent change | Standard Deviation 27.3 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part III | Week 40, n=45 | -50.58 percent change | Standard Deviation 25.887 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part III | Week 44, n=45 | -49.51 percent change | Standard Deviation 32.903 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part III | Week 48, n=44 | -53.05 percent change | Standard Deviation 28.456 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part III | Week 52, n=44 | -51.11 percent change | Standard Deviation 31.617 |
Secondary
Percent Change From Baseline in the Japanese UPDRS Part IV
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per each item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.
Time frame: Baseline (Week 0) and Weeks 1-52
Population: FAS. Participants dropped out of the study each week.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part IV | Week 28, n=13 | -23.08 percent change | Standard Deviation 59.914 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part IV | Week 40, n=12 | -41.67 percent change | Standard Deviation 79.296 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part IV | Week 44, n=12 | -25.00 percent change | Standard Deviation 75.378 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part IV | Week 48, n=12 | -41.67 percent change | Standard Deviation 66.856 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part IV | Week 52, n=12 | -41.67 percent change | Standard Deviation 51.493 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part IV | Week 1, n=21 | -2.38 percent change | Standard Deviation 64.18 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part IV | Week 2, n=20 | 17.50 percent change | Standard Deviation 71.221 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part IV | Week 3, n=19 | 10.53 percent change | Standard Deviation 79.196 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part IV | Week 4, n=19 | 7.89 percent change | Standard Deviation 75.024 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part IV | Week 6, n=18 | -5.56 percent change | Standard Deviation 72.536 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part IV | Week 8, n=17 | -35.29 percent change | Standard Deviation 60.634 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part IV | Week 10, n=18 | -16.67 percent change | Standard Deviation 70.711 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part IV | Week 12, n=17 | -14.71 percent change | Standard Deviation 70.189 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part IV | Week 16, n=16 | -15.63 percent change | Standard Deviation 50.724 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part IV | Final Assessment Point (Up to Week 16), n=21 | -16.67 percent change | Standard Deviation 48.305 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part IV | Week 20, n=15 | -6.67 percent change | Standard Deviation 79.881 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part IV | Week 24, n=14 | -25.00 percent change | Standard Deviation 58.012 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part IV | Week 32, n=13 | -34.62 percent change | Standard Deviation 62.532 |
| Ropinirole PR/XR | Percent Change From Baseline in the Japanese UPDRS Part IV | Week 36, n=13 | -26.92 percent change | Standard Deviation 72.501 |
Secondary
Summary of the Modified Hoehn & Yahr Criteria Stages
Hoehn & Yahr criteria were measured on an 8-point scale. 0: No signs of disease, 1: Unilateral disease, 1.5: Unilateral plus axial involvement, 2: Bilateral disease, 2.5: Mild bilateral disease, 3: Mild to moderate bilateral disease. No subjects evaluated had a score of 4 (severe disability) or 5 (wheelchair bound or bedridden unless aided).
Time frame: Screening-Week 52
Population: FAS. Participants dropped out of the study each week.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 10, Stage 2 | 21 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 16, Stage 1 | 16 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 16, Stage 2.5 | 4 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Final Assessment Point (Up to Week 16), Stage 3 | 7 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 28, Stage 2.5 | 5 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 28, Stage 3 | 6 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Screening, Stage 0 | 0 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Screening, Stage 1 | 7 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Screening, Stage 1.5 | 7 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Screening, Stage 2 | 18 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 32, Stage 2 | 19 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 32, Stage 2.5 | 5 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 32, Stage 3 | 5 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 36, Stage 0 | 2 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 36, Stage 1 | 13 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 36, Stage 1.5 | 2 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 36, Stage 2 | 19 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 36, Stage 2.5 | 6 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 36, Stage 3 | 5 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 40, Stage 0 | 2 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 40, Stage 1 | 12 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 40, Stage 1.5 | 2 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 40, Stage 2 | 18 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 40, Stage 2.5 | 7 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 40, Stage 3 | 4 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 44, Stage 0 | 2 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 44, Stage 1 | 16 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 44, Stage 1.5 | 2 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Screening, Stage 2.5 | 12 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Screening, Stage 3 | 18 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 0, Stage 0 | 0 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 0, Stage 1 | 6 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 0, Stage 1.5 | 5 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 0, Stage 2 | 23 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 0, Stage 2.5 | 12 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 0, Stage 3 | 16 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 1, Stage 0 | 0 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 1, Stage 1 | 8 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 1, Stage 1.5 | 4 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 1, Stage 2 | 24 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 1, Stage 2.5 | 12 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 1, Stage 3 | 14 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 2, Stage 0 | 1 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 2, Stage 1 | 8 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 2, Stage 1.5 | 5 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 2, Stage 2 | 22 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 2, Stage 2.5 | 12 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 2, Stage 3 | 12 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 3, Stage 0 | 0 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 3, Stage 1 | 12 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 3, Stage 1.5 | 3 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 3, Stage 2 | 26 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 3, Stage 2.5 | 8 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 3, Stage 3 | 11 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 4, Stage 0 | 0 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 4, Stage 1 | 12 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 4, Stage 1.5 | 5 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 4, Stage 2 | 26 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 4, Stage 2.5 | 7 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 4, Stage 3 | 8 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 6, Stage 0 | 1 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 6, Stage 1 | 17 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 6, Stage 1.5 | 4 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 6, Stage 2 | 23 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 6, Stage 2.5 | 3 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 6, Stage 3 | 9 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 8, Stage 0 | 1 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 8, Stage 1 | 18 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 8, Stage 1.5 | 5 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 8, Stage 2 | 21 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 8, Stage 2.5 | 7 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 8, Stage 3 | 4 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 10, Stage 0 | 3 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 10, Stage 1 | 19 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 10, Stage 1.5 | 7 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 44, Stage 2 | 14 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 10, Stage 2.5 | 2 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 10, Stage 3 | 5 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 12, Stage 0 | 3 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 12, Stage 1 | 18 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 12, Stage 1.5 | 8 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 12, Stage 2 | 17 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 12, Stage 2.5 | 5 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 12, Stage 3 | 5 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 16, Stage 0 | 3 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 16, Stage 1.5 | 6 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 16, Stage 2 | 20 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 16, Stage 3 | 5 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Final Assessment Point (Up to Week 16), Stage 0 | 3 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Final Assessment Point (Up to Week 16), Stage 1 | 18 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Final Assessment Point (Up to Week 16), Stage 1.5 | 6 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Final Assessment Point (Up to Week 16), Stage 2 | 23 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Final Assessment Point (Up to Week 16), Stage 2.5 | 5 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 20, Stage 0 | 4 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 20, Stage 1 | 16 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 20, Stage 1.5 | 3 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 20, Stage 2 | 20 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 20, Stage 2.5 | 3 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 20, Stage 3 | 7 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 24, Stage 0 | 3 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 24, Stage 1 | 14 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 24, Stage 1.5 | 3 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 24, Stage 2 | 22 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 24, Stage 2.5 | 4 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 44, Stage 2.5 | 5 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 44, Stage 3 | 6 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 48, Stage 0 | 1 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 48, Stage 1 | 16 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 48, Stage 1.5 | 1 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 48, Stage 2 | 16 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 24, Stage 3 | 5 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 48, Stage 2.5 | 4 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 48, Stage 3 | 6 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 52, Stage 0 | 1 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 52, Stage 1 | 15 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 52, Stage 1.5 | 2 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 52, Stage 2 | 16 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 52, Stage 2.5 | 5 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 52, Stage 3 | 5 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 28, Stage 0 | 2 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 28, Stage 1 | 14 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 28, Stage 1.5 | 4 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 28, Stage 2 | 17 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 32, Stage 0 | 2 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 32, Stage 1 | 14 points on a scale |
| Ropinirole PR/XR | Summary of the Modified Hoehn & Yahr Criteria Stages | Week 32, Stage 1.5 | 2 points on a scale |
Secondary
Total Score in the Japanese UPDRS Part I
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per each item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.
Time frame: Weeks 0-52
Population: FAS. Participants dropped out of the study each week.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part I | Week 0, n=62 | 1.0 points on a scale | Standard Deviation 1.36 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part I | Week 1, n=62 | 0.7 points on a scale | Standard Deviation 1.09 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part I | Week 2, n=60 | 0.6 points on a scale | Standard Deviation 0.96 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part I | Week 3, n=60 | 0.5 points on a scale | Standard Deviation 1.06 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part I | Week 4, n=58 | 0.4 points on a scale | Standard Deviation 1.06 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part I | Week 6, n=57 | 0.5 points on a scale | Standard Deviation 1.04 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part I | Week 8, n=56 | 0.5 points on a scale | Standard Deviation 1.1 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part I | Week 10, n=57 | 0.6 points on a scale | Standard Deviation 1.39 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part I | Week 12, n=56 | 0.4 points on a scale | Standard Deviation 1.07 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part I | Week 16, n=54 | 0.4 points on a scale | Standard Deviation 1.31 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part I | Final Assessment Point (Up to Week 16), n=62 | 0.4 points on a scale | Standard Deviation 1.3 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part I | Week 20, n=53 | 0.3 points on a scale | Standard Deviation 0.88 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part I | Week 24, n=51 | 0.4 points on a scale | Standard Deviation 0.87 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part I | Week 28, n=48 | 0.3 points on a scale | Standard Deviation 0.57 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part I | Week 32, n=47 | 0.3 points on a scale | Standard Deviation 0.61 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part I | Week 36, n=47 | 0.4 points on a scale | Standard Deviation 0.64 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part I | Week 40, n=45 | 0.3 points on a scale | Standard Deviation 0.58 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part I | Week 44, n=45 | 0.3 points on a scale | Standard Deviation 0.67 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part I | Week 48, n=44 | 0.3 points on a scale | Standard Deviation 0.73 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part I | Week 52, n=44 | 0.3 points on a scale | Standard Deviation 0.8 |
Secondary
Total Score in the Japanese UPDRS Part II
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per each item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms.
Time frame: Weeks 0-52
Population: FAS. Participants dropped out of the study each week.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part II | Week 0, n=62 | 8.2 points on a scale | Standard Deviation 4.55 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part II | Week 1, n=62 | 7.2 points on a scale | Standard Deviation 4.41 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part II | Week 2, n=60 | 6.3 points on a scale | Standard Deviation 4 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part II | Week 3, n=60 | 5.5 points on a scale | Standard Deviation 3.82 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part II | Week 4, n=58 | 4.8 points on a scale | Standard Deviation 3.79 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part II | Week 6, n=57 | 4.5 points on a scale | Standard Deviation 3.76 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part II | Week 8, n=56 | 4.0 points on a scale | Standard Deviation 3.64 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part II | Week 10, n=57 | 4.1 points on a scale | Standard Deviation 3.95 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part II | Week 12, n=56 | 4.2 points on a scale | Standard Deviation 3.77 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part II | Week 16, n=54 | 4.1 points on a scale | Standard Deviation 3.5 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part II | Final Assessment Point (Up to Week 16), n=62 | 4.3 points on a scale | Standard Deviation 3.69 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part II | Week 20, n=53 | 4.1 points on a scale | Standard Deviation 3.57 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part II | Week 24, n=51 | 3.7 points on a scale | Standard Deviation 3.38 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part II | Week 28, n=48 | 4.0 points on a scale | Standard Deviation 3.79 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part II | Week 32, n=47 | 3.9 points on a scale | Standard Deviation 3.61 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part II | Week 36, n=47 | 4.0 points on a scale | Standard Deviation 3.73 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part II | Week 40, n=45 | 4.1 points on a scale | Standard Deviation 3.9 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part II | Week 44, n=45 | 4.2 points on a scale | Standard Deviation 4.14 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part II | Week 48, n=44 | 3.8 points on a scale | Standard Deviation 3.88 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part II | Week 52, n=44 | 4.1 points on a scale | Standard Deviation 4.13 |
Secondary
Total Score in the Japanese UPDRS Part III
The Unified Parkinson's Disease Rating Scale (UPDRS) assesses the status of Parkinson's Disease (PD) patients objectively. The Japanese UPDRS Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per each item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.
Time frame: Weeks 0-52
Population: Full Analysis Set (FAS): all participants who progressed to the treatment phase, excluding those who did not fulfill major registration criteria, those who had not received at least one dose of the investigational drug, and those whose measured data were not available after treatment initiation. Participants dropped out of the study each week.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part III | Week 6, n=57 | 12.1 points on a scale | Standard Deviation 8.47 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part III | Week 0, n=62 | 22.4 points on a scale | Standard Deviation 10.11 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part III | Week 1, n=62 | 19.3 points on a scale | Standard Deviation 9.38 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part III | Week 2, n=60 | 16.8 points on a scale | Standard Deviation 8.89 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part III | Week 3, n=60 | 14.5 points on a scale | Standard Deviation 8.57 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part III | Week 4, n=58 | 13.0 points on a scale | Standard Deviation 8.6 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part III | Week 8, n=56 | 11.1 points on a scale | Standard Deviation 7.87 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part III | Week 10, n=57 | 10.2 points on a scale | Standard Deviation 7.84 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part III | Week 12, n=56 | 10.1 points on a scale | Standard Deviation 7.18 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part III | Week 16, n=54 | 10.3 points on a scale | Standard Deviation 6.98 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part III | Final Assessment Point (Up to Week 16), n=62 | 11.1 points on a scale | Standard Deviation 7.52 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part III | Week 20, n=53 | 10.4 points on a scale | Standard Deviation 7.2 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part III | Week 24, n=51 | 10.6 points on a scale | Standard Deviation 7.47 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part III | Week 28, n=48 | 10.6 points on a scale | Standard Deviation 7.69 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part III | Week 32, n=47 | 10.7 points on a scale | Standard Deviation 7.68 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part III | Week 36, n=47 | 10.7 points on a scale | Standard Deviation 7.35 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part III | Week 40, n=45 | 11.0 points on a scale | Standard Deviation 8.04 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part III | Week 44, n=45 | 11.3 points on a scale | Standard Deviation 9.3 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part III | Week 48, n=44 | 10.2 points on a scale | Standard Deviation 7.52 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part III | Week 52, n=44 | 10.7 points on a scale | Standard Deviation 7.73 |
Secondary
Total Score in the Japanese UPDRS Part IV
The UPDRS assesses the status of PD patients objectively. The Japanese UPDRS Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per each item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.
Time frame: Baseline (Week 0) and Weeks 0-52
Population: FAS. Participants dropped out of the study each week.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part IV | Final Assessment Point (Up to Week 16), n=62 | 0.6 points on a scale | Standard Deviation 0.66 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part IV | Week 0, n=62 | 0.4 points on a scale | Standard Deviation 0.58 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part IV | Week 1, n=62 | 0.6 points on a scale | Standard Deviation 0.71 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part IV | Week 2, n=60 | 0.8 points on a scale | Standard Deviation 0.82 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part IV | Week 3, n=60 | 0.7 points on a scale | Standard Deviation 0.78 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part IV | Week 4, n=58 | 0.7 points on a scale | Standard Deviation 0.82 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part IV | Week 6, n=57 | 0.7 points on a scale | Standard Deviation 0.78 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part IV | Week 8, n=56 | 0.5 points on a scale | Standard Deviation 0.63 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part IV | Week 10, n=57 | 0.5 points on a scale | Standard Deviation 0.68 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part IV | Week 12, n=56 | 0.5 points on a scale | Standard Deviation 0.66 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part IV | Week 16, n=54 | 0.6 points on a scale | Standard Deviation 0.63 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part IV | Week 20, n=53 | 0.6 points on a scale | Standard Deviation 0.71 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part IV | Week 24, n=51 | 0.5 points on a scale | Standard Deviation 0.64 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part IV | Week 28, n=48 | 0.6 points on a scale | Standard Deviation 0.7 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part IV | Week 32, n=47 | 0.5 points on a scale | Standard Deviation 0.62 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part IV | Week 36, n=47 | 0.6 points on a scale | Standard Deviation 0.62 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part IV | Week 40, n=45 | 0.4 points on a scale | Standard Deviation 0.58 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part IV | Week 44, n=45 | 0.5 points on a scale | Standard Deviation 0.59 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part IV | Week 48, n=44 | 0.5 points on a scale | Standard Deviation 0.59 |
| Ropinirole PR/XR | Total Score in the Japanese UPDRS Part IV | Week 52, n=44 | 0.5 points on a scale | Standard Deviation 0.63 |
Secondary
Urinalysis Data
The number of participants with the indicated dipstick test values were measured. Dipstick test values: Neg Value, Trace, +1, +2, +3, +4. No participants had a score of +5.
Time frame: Screening, Week 16, and Week 52
Population: Safety Population: Screening Week 16 (LOCF) = 62 participants; Week 52 (OC) = 44 participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ropinirole PR/XR | Urinalysis Data | Urine Urobilinogen - Week 52: +4 | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Occult Blood - Week 16: Trace | 4 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Occult Blood - Week 16: +1 | 5 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Occult Blood - Week 16: +2 | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Occult Blood - Week 16: +3 | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Occult Blood - Week 16: +4 | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Occult Blood - Week 52: Neg Value | 41 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Occult Blood - Week 52: Trace | 1 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Occult Blood - Week 16: Neg Value | 53 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Occult Blood - Screening: Neg Value | 52 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Occult Blood - Screening: Trace | 7 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Occult Blood - Screening: +1 | 1 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Occult Blood - Screening: +2 | 1 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Occult Blood - Screening: +3 | 1 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Occult Blood - Screening: +4 | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Occult Blood - Week 52: +1 | 2 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Occult Blood - Week 52: +2 | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Occult Blood - Week 52: +3 | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Occult Blood - Week 52: +4 | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Glucose - Screening: Neg Value | 57 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Glucose - Screening: Trace | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Glucose - Screening: +1 | 1 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Glucose - Screening: +2 | 2 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Glucose - Screening: +3 | 1 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Glucose - Screening: +4 | 1 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Glucose - Week 16: Neg Value | 59 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Glucose - Week 16: Trace | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Glucose - Week 16: +1 | 2 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Glucose - Week 16: +2 | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Glucose - Week 16: +3 | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Glucose - Week 16: +4 | 1 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Glucose - Week 52: Neg Value | 41 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Glucose - Week 52: Trace | 2 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Glucose - Week 52: +1 | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Glucose - Week 52: +2 | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Glucose - Week 52: +3 | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Glucose - Week 52: +4 | 1 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Protein - Screening: Neg Value | 60 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Protein - Screening: Trace | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Protein - Screening: +1 | 2 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Protein - Screening: +2 | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Protein - Screening: +3 | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Protein - Screening: +4 | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Protein - Week 16: Neg Value | 55 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Protein - Week 16: Trace | 3 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Protein - Week 16: +1 | 3 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Protein - Week 16: +2 | 1 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Protein - Week 16: +3 | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Protein - Week 16: +4 | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Protein - Week 52: Neg Value | 43 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Protein - Week 52: Trace | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Protein - Week 52: +1 | 1 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Protein - Week 52: +2 | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Protein - Week 52: +3 | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Protein - Week 52: +4 | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Urobilinogen - Screening: Neg Value | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Urobilinogen - Screening: Trace | 62 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Urobilinogen - Screening: +1 | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Urobilinogen - Screening: +2 | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Urobilinogen - Screening: +3 | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Urobilinogen - Screening: +4 | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Urobilinogen - Week 16: Neg Value | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Urobilinogen - Week 16: Trace | 61 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Urobilinogen - Week 16: +1 | 1 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Urobilinogen - Week 16: +2 | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Urobilinogen - Week 16: +3 | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Urobilinogen - Week 16: +4 | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Urobilinogen - Week 52: Neg Value | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Urobilinogen - Week 52: Trace | 43 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Urobilinogen - Week 52: +1 | 1 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Urobilinogen - Week 52: +2 | 0 participants |
| Ropinirole PR/XR | Urinalysis Data | Urine Urobilinogen - Week 52: +3 | 0 participants |