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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

Description

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)

Participant Flow:   Overall Study

	Ropinirole PR/XR
STARTED	62
COMPLETED	42
NOT COMPLETED	20
Adverse Event	14
Lack of Efficacy	2
Withdrawal by Subject	4

Reporting Groups

Description

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)

Baseline Measures

	Ropinirole PR/XR
Number of Participants   [units: participants]	62
Age   [units: years] Mean ± Standard Deviation	67.2  ± 8.05
Gender   [units: participants]
Female	37
Male	25
Race/Ethnicity, Customized   [units: participants]
Asian – Japanese Heritage	62

1.  Primary:

Food Effects on Cmax and Cmin of SKF101468 (Ropinirole) and Its Metabolites   [ Time Frame: Weeks 5-16 ]

2.  Primary:

Food Effects on AUC0-24 of SKF101468 (Ropinirole) and Its Metabolites   [ Time Frame: Weeks 5-16 ]

3.  Primary:

Food Effects on Tmax of SKF101468 (Ropinirole) and Its Metabolites   [ Time Frame: Weeks 5-16 ]

4.  Primary:

Plasma Trough Concentrations of SKF101468 (Ropinirole) and Its Metabolites   [ Time Frame: Weeks 1-16 ]

5.  Secondary:

Total Score in the Japanese UPDRS Part III   [ Time Frame: Weeks 0-52 ]

6.  Secondary:

Change From Baseline in the Japanese UPDRS Part III   [ Time Frame: Baseline (Week 0) and Weeks 1-52 ]

7.  Secondary:

Percent Change From Baseline in the Japanese UPDRS Part III   [ Time Frame: Baseline (Week 0) and Weeks 1-52 ]

8.  Secondary:

Percentage of Responders of the Total Score in the Japanese UPDRS Total Score in Part III   [ Time Frame: Baseline (Week 0) and Weeks 1-52 ]

9.  Secondary:

Total Score in the Japanese UPDRS Part I   [ Time Frame: Weeks 0-52 ]

10.  Secondary:

Change From Baseline in the Japanese UPDRS Part I   [ Time Frame: Baseline (Week 0) and Weeks 1-52 ]

11.  Secondary:

Percent Change From Baseline in the Japanese UPDRS Part I   [ Time Frame: Baseline (Week 0) and Weeks 1-52 ]

12.  Secondary:

Total Score in the Japanese UPDRS Part II   [ Time Frame: Weeks 0-52 ]

13.  Secondary:

Change From Baseline in the Japanese UPDRS Part II   [ Time Frame: Baseline (Week 0) and Weeks 1-52 ]

14.  Secondary:

Percent Change From Baseline in the Japanese UPDRS Part II   [ Time Frame: Baseline (Week 0) and Weeks 1-52 ]

15.  Secondary:

Total Score in the Japanese UPDRS Part IV   [ Time Frame: Baseline (Week 0) and Weeks 0-52 ]

16.  Secondary:

Change From Baseline in the Japanese UPDRS Part IV   [ Time Frame: Baseline (Week 0) and Weeks 1-52 ]

17.  Secondary:

Percent Change From Baseline in the Japanese UPDRS Part IV   [ Time Frame: Baseline (Week 0) and Weeks 1-52 ]

18.  Secondary:

Summary of the Modified Hoehn & Yahr Criteria Stages   [ Time Frame: Screening-Week 52 ]

19.  Secondary:

Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale   [ Time Frame: Weeks 1-52 ]

20.  Secondary:

Percentage of Participants Who Remained in the Study on the Indicated Days   [ Time Frame: Days 0-364 ]

21.  Secondary:

Change From Baseline in Albumin, Total Protein, and Hemoglobin at Weeks 16 and 52   [ Time Frame: Baseline (Screening) and Weeks 16 and 52 ]

22.  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   [ Time Frame: Baseline (Screening) and Weeks 16 and 52 ]

23.  Secondary:

Change From Baseline in Total Bilirubin, Blood Urea Nitrogen, and Creatinine at Weeks 16 and 52   [ Time Frame: Baseline (Screening) and Weeks 16 and 52 ]

24.  Secondary:

Change From Baseline in Blood Urea Nitrogen, Cholesterol, Chloride, Potassium, and Sodium at Weeks 16 and 52   [ Time Frame: Baseline (Screening) and Weeks 16 and 52 ]

25.  Secondary:

Change From Baseline in Prolactin at Weeks 16 and 52   [ Time Frame: Baseline (Screening) and Weeks 16 and 52 ]

26.  Secondary:

Change From Baseline in Hematocrit at Weeks 16 and 52   [ Time Frame: Baseline (Screening) and Weeks 16 and 52 ]

27.  Secondary:

Change From Baseline in Platelet Count and White Blood Cell Count at Weeks 16 and 52   [ Time Frame: Baseline (Screening) and Weeks 16 and 52 ]

28.  Secondary:

Change From Baseline in Red Blood Cell Count at Weeks 16 and 52   [ Time Frame: Baseline (Screening) and Weeks 16 and 52 ]

29.  Secondary:

Urinalysis Data   [ Time Frame: Screening, Week 16, and Week 52 ]

30.  Secondary:

Number of Participants With the Indicated Shift From Baseline in 12-Lead Electrocardiogram (ECG) Findings at Weeks 16 and 52   [ Time Frame: Baseline (Screening) and Weeks 16 and 52 ]

31.  Secondary:

Change From Baseline in Supine and Standing Systolic and Diastolic Blood Pressure at Weeks 16 and 52   [ Time Frame: Baseline (Screening) and Weeks 16 and 52 ]

32.  Secondary:

Change From Baseline in Supine and Standing Pulse Rate at Weeks 16 and 52   [ Time Frame: Baseline (Screening) and Weeks 16 and 52 ]