REQUIP (Ropinirole Hydrochloride) IR Long-Term Phase 4 Study

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
52 weeks of Treatment Phase, consisting of 4 weeks of Fixed Titration Phase and 48 weeks of Flexible Titration and Maintenance Phase, was started after 1 to 4 weeks of Screening Phase. Although the results are presented by participants with and without L-dopa, this study was a single-arm design, and L-dopa was not the investigational product.

Reporting Groups

	Description
ROP+L-Dopa	Participants received ropinirole hydrochloride (ROP) tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 milligrams (mg)/day and was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals of at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
Ropinirole Hydrochloride	Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day and was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals of at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.

Participant Flow:   Overall Study

	ROP+L-Dopa	Ropinirole Hydrochloride
STARTED	65	58
COMPLETED	47	46
NOT COMPLETED	18	12
Adverse Event	10	4
Lack of Efficacy	2	1
Protocol Violation	0	1
Withdrawal by Subject	6	6

Reporting Groups

	Description
ROP+L-Dopa	Participants received ropinirole hydrochloride (ROP) tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 milligrams (mg)/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
Ropinirole Hydrochloride	Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
Total	Total of all reporting groups

Baseline Measures

	ROP+L-Dopa	Ropinirole Hydrochloride	Total
Number of Participants   [units: participants]	65	58	123
Age   [units: Years] Mean ± Standard Deviation	66.0  ± 7.94	65.5  ± 7.18	65.8  ± 7.56
Gender   [units: Participants]
Female	27	31	58
Male	38	27	65
Race/Ethnicity, Customized   [units: participants]
Asian - Japanese Heritage	65	58	123
Other	0	0	0

1.  Primary:

Mean Change From Baseline in the Japanese Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score (in "On" State for the ROP+L-Dopa Group) at Week 52 and Final Assessment Point (FAP)   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

2.  Secondary:

Mean Change From Baseline in the Japanese UPDRS Part I Total Score at Week 52 and FAP   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

3.  Secondary:

Mean Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP by "On"/"Off" State in the ROP+L-Dopa Group   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

4.  Secondary:

Mean Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP in the ROP Group   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

5.  Secondary:

Mean Change From Baseline in the Japanese UPDRS Part IV Total Score at Week 52 and FAP   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

6.  Secondary:

Japanese UPDRS Part I Mean Total Score at Baseline, Week 52, and FAP   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

7.  Secondary:

Mean Percent Change From Baseline in the Japanese UPDRS Part I Total Score at Week 52 and FAP   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

8.  Secondary:

Japanese UPDRS Part II Mean Total Score at Baseline, Week 52, and FAP by "On"/"Off" State in the ROP+L-Dopa Group   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

9.  Secondary:

Japanese UPDRS Part II Mean Total Score at Baseline, Week 52, and FAP in ROP Group   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

10.  Secondary:

Mean Percent Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP by "On"/"Off" State in the ROP+L-Dopa Group   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

11.  Secondary:

Mean Percent Change From Baseline in the Japanese UPDRS Part II Total Score at Week 52 and FAP in the ROP Group   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

12.  Secondary:

Japanese UPDRS Part III Mean Total Score (in "On" State for the ROP+L-Dopa Group) at Baseline, Week 52, and FAP   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

13.  Secondary:

Mean Percent Change From Baseline in the Japanese UPDRS Part III Total Score (in "On" State for the ROP+L-Dopa Group) at Week 52 and FAP   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

14.  Secondary:

Japanese UPDRS Part IV Mean Total Score at Baseline, Week 52, and FAP   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

15.  Secondary:

Mean Percent Change From Baseline in the Japanese UPDRS Part IV Total Score at Week 52 and FAP   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

16.  Secondary:

Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP by "On"/"Off" State in the ROP+L-Dopa Group   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

17.  Secondary:

Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP in the ROP Group   [ Time Frame: Number of Participants at Each Stage of the Modified Hoehn & Yahr Scale at Baseline, Week 52, and FAP in the ROP Group ]

18.  Secondary:

Mean Change From Baseline in the Schwab and England Activities of Daily Living Scale Score by Clinician at Week 52 and FAP by "On"/"Off" State in the ROP+L-Dopa Group   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

19.  Secondary:

Mean Change From Baseline in the Schwab and England Activities of Daily Living Scale Score by Clinician at Week 52 and FAP in ROP Group   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]

20.  Secondary:

Percentage of Participants Remaining in the Study on the Indicated Days in the ROP+L-Dopa Group   [ Time Frame: Days 0-422 ]

21.  Secondary:

Percentage of Participants Remaining in the Study on the Indicated Days in the ROP Group   [ Time Frame: Days 0-419 ]

22.  Secondary:

Number of Participants Scored as Responders on the Clinician's Global Impression (CGI) Scale at Week 52 and FAP   [ Time Frame: Week 52 and FAP (up to Week 52) ]

23.  Secondary:

Mean Change From Baseline in Awake Time "Off" (Hours) and Awake Time "On" (Hours) at Week 52 and FAP in the ROP+L-Dopa Group Excluding Participants With "0" Off (Hour) at Baseline   [ Time Frame: Baseline, Week 52, and FAP (up to Week 52) ]