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 CR-RLS	Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.

Participant Flow:   Overall Study

	Ropinirole CR-RLS
STARTED	35
COMPLETED	30
NOT COMPLETED	5
Adverse Event	2
Withdrawal by Subject	2
Physician Decision	1

Reporting Groups

	Description
Ropinirole CR-RLS	Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.

Baseline Measures

	Ropinirole CR-RLS
Number of Participants   [units: participants]	35
Age   [units: years] Mean ± Standard Deviation	48.2 ± 14.7
Gender   [units: Number of participants]
Female	23
Male	12
Region of Enrollment   [units: Number of participants]
Japan	35

1.  Primary:

Drug Related Adverse Events-On-Therapy   [ Weeks 1 - 12 Treatment Period ]

2.  Primary:

Haematology Clinical Lab Values Change From Baseline   [ Baseline - Week 13 (Follow-up) ]

3.  Primary:

Blood Chemistry Clinical Lab Values Change From Baseline   [ Baseline - Week 13 (Follow-up) ]

4.  Primary:

Urinalysis Clinical Lab Values   [ Baseline - Week 13 (Follow-up) ]

5.  Primary:

12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline   [ Baseline, Week 4, 8, 12, 13 (Follow-up) ]

6.  Primary:

Vital Signs and Body Weight Change From Baseline   [ Baseline to Week 12/EW ]

7.  Secondary:

Change From Baseline to Week 12 in International Restless Leg Syndrome (IRLS) Rating Scale Total Score   [ Baseline and after Week 12 ]

8.  Secondary:

Clinical Global Impression Scale - Severity of Illness (CGI-S)   [ Baseline - Final assessment point ]

9.  Secondary:

Clinical Global Impression Global Improvement (CGI-GI)   [ Baseline - Final assessment point ]

10.  Secondary:

Change From Baseline at Week 12/Early Withdrawal (EW) in Pittsburgh Sleep Quality Index (PSQI) Total Score   [ Baseline - Week 12/EW ]

11.  Secondary:

Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains   [ Baseline - Week 12/EW ]

12.  Secondary:

Change From Baseline at Week 12/Early Withdrawal (EW) in Johns Hopkins Restless Leg Syndrome Quality of Life Questionnaire (RLSQOL) on the Overall Life Impact Score   [ Baseline and Week 12/EW ]

13.  Secondary:

Change From Baseline at Week 12/Early Withdrawal (EW) in Profile of Mood Status (POMS)   [ Baseline and Week 12/EW ]

14.  Secondary:

Change From Baseline at Week 12/Early Withdrawal (EW) in Hospital Anxiety and Depression Scale (HADS)   [ Baseline - Week 12/EW ]

15.  Secondary:

Pharmacokinetic Analysis: Plasma Concentrations of SK&F101468, an Unchanged Form of Ropinirole.   [ Weeks 1-12 ]

16.  Secondary:

Pharmacokinetic Analysis: Plasma Concentrations of SK&F104557, a Circulating Metabolite of Ropinirole.   [ Weeks 1 -12 ]

17.  Secondary:

Pharmacokinetic Analysis: Plasma Concentrations of SK&F89124, a Circulating Metabolite of Ropinirole.   [ Weeks 1-12 ]