This study was designed to evaluate the pharmacokinetic profile, safety and efficacy in Parkinson's Disease patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
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).
GSK Investigational Site
Aichi, Japan
GSK Investigational Site
Aichi, Japan
GSK Investigational Site
Chiba, Japan
GSK Investigational Site
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
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
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
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
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Ehime, Japan
GSK Investigational Site
Hokkaido, Japan
GSK Investigational Site
Kanagawa, Japan
GSK Investigational Site
Kyoto, Japan
GSK Investigational Site
Numakunai, Japan
GSK Investigational Site
Osaka, Japan
GSK Investigational Site
Saitama, Japan
...and 2 more locations
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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