Trial Outcomes & Findings for Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome) (NCT NCT00256854)

Last Updated: 2019-03-15

Results Overview

AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. In each of the 6 cohorts, there were 2 conversions, one of which was IR to CR-RLS and the other one IR to IR. Two populations were defined: the first conversion population and the second conversion population. The first conversion population consisted of all participants receiving at least one dose of randomized drug during the pre-conversion 1 period and during the post-conversion 1 period. The second conversion population consisted of all participants receiving at least one dose of randomized drug during the pre-conversion 2 period and during the post-conversion 2 period.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

135 participants

Primary outcome timeframe

Up to 5 weeks

Results posted on

2019-03-15

Participant Flow

This study was conducted from 14 November 2005 till 21 September 2006 across 27 centers in the United States (US).

Participants with RLS were screened for 1 week; however, it could had been extended maximum up to 4 weeks. During screening period, participants received Ropinirole immediate release (IR) 1 milligrams (mg), 2 mg, or 4 mg across Cohorts A, B, and C. A total of 135 participants were randomized in the study.

Participant milestones

Participant milestones
Measure	Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 2 mg controlled release for Restless Legs Syndrome (CR-RLS) in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 1 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.	Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 2 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.	Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 4 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
Overall Study STARTED	26	26	26	27	16	14
Overall Study COMPLETED	23	22	23	24	15	13
Overall Study NOT COMPLETED	3	4	3	3	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 2 mg controlled release for Restless Legs Syndrome (CR-RLS) in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 1 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.	Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 2 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.	Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 4 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
Overall Study Withdrawal by Subject	2	3	0	0	0	0
Overall Study Lack of Efficacy	1	0	0	0	0	0
Overall Study Protocol Violation	0	1	1	1	0	0
Overall Study Adverse Event	0	0	2	2	0	1
Overall Study Not compliant with the study drug	0	0	0	0	1	0

Baseline Characteristics

Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR n=26 Participants Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 1 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS n=26 Participants Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.	Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR n=26 Participants Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 2 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS n=27 Participants Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.	Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR n=16 Participants Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 4 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS n=14 Participants Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.	Total n=135 Participants Total of all reporting groups
Age, Continuous	56.8 Years STANDARD_DEVIATION 12.91 • n=5 Participants	57.4 Years STANDARD_DEVIATION 8.69 • n=7 Participants	59.2 Years STANDARD_DEVIATION 10.21 • n=5 Participants	53.7 Years STANDARD_DEVIATION 13.94 • n=4 Participants	58.3 Years STANDARD_DEVIATION 11.96 • n=21 Participants	57.1 Years STANDARD_DEVIATION 9.67 • n=10 Participants	57.0 Years STANDARD_DEVIATION 11.44 • n=115 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	18 Participants n=7 Participants	14 Participants n=5 Participants	18 Participants n=4 Participants	7 Participants n=21 Participants	7 Participants n=10 Participants	84 Participants n=115 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants	9 Participants n=4 Participants	9 Participants n=21 Participants	7 Participants n=10 Participants	51 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	3 Participants n=115 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	24 Participants n=7 Participants	25 Participants n=5 Participants	27 Participants n=4 Participants	15 Participants n=21 Participants	14 Participants n=10 Participants	130 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants

PRIMARY outcome

Timeframe: Up to 5 weeks

Population: Conversion population. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR n=24 Participants Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 1 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS n=24 Participants Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.	Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR n=26 Participants Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 2 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS n=26 Participants Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.	Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR n=15 Participants Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 4 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS n=13 Participants Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
Number of Participants With Adverse Events (AEs) Post-conversion From Ropinirole IR to Ropinirole CR Over Period Post-conversion 1	9 Participants	14 Participants	10 Participants	11 Participants	7 Participants	5 Participants
Number of Participants With Adverse Events (AEs) Post-conversion From Ropinirole IR to Ropinirole CR Over Period Post-conversion 2	6 Participants	8 Participants	7 Participants	6 Participants	5 Participants	6 Participants

SECONDARY outcome

Timeframe: Up to 5 weeks

Population: Conversion population. Only those participants available at the specified time points were analyzed.

AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. Onset of an AE was pre-Conversion 1 and discontinuation for the same AE occurred post-Conversion 1. Serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.

Outcome measures

Outcome measures
Measure	Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR n=24 Participants Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 1 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS n=24 Participants Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.	Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR n=26 Participants Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 2 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS n=26 Participants Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.	Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR n=15 Participants Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 4 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS n=13 Participants Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
Number of Participants Discontinuing the Drug Due to AEs Post Conversion From Ropinirole IR to Ropinirole CR-RLS Post-conversion 1	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants Discontinuing the Drug Due to AEs Post Conversion From Ropinirole IR to Ropinirole CR-RLS Post-conversion 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 5 weeks

Population: Conversion population. Only those participants available at the specified time points were analyzed.

SAE is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above. Severity was measured in terms of grades mild, moderate, and severe. SAEs data only for post-conversion has been reported.

Outcome measures

Outcome measures
Measure	Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR n=24 Participants Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 1 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS n=24 Participants Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.	Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR n=26 Participants Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 2 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS n=26 Participants Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.	Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR n=15 Participants Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 4 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS n=13 Participants Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
Number of Participants With SAEs and Severity of AEs Any SAE, post conversion 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With SAEs and Severity of AEs Any SAE, post conversion 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With SAEs and Severity of AEs Mild AE, post conversion 1	5 Participants	9 Participants	5 Participants	6 Participants	3 Participants	2 Participants
Number of Participants With SAEs and Severity of AEs Moderate AE, post conversion 1	4 Participants	7 Participants	4 Participants	6 Participants	4 Participants	4 Participants
Number of Participants With SAEs and Severity of AEs Severe AE, post conversion 1	2 Participants	5 Participants	6 Participants	2 Participants	2 Participants	1 Participants
Number of Participants With SAEs and Severity of AEs Mild AE, post conversion 2	3 Participants	2 Participants	1 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With SAEs and Severity of AEs Moderate AE, post conversion 2	2 Participants	4 Participants	3 Participants	5 Participants	4 Participants	1 Participants
Number of Participants With SAEs and Severity of AEs Severe AE, post conversion 2	2 Participants	2 Participants	3 Participants	0 Participants	0 Participants	4 Participants

SECONDARY outcome

Timeframe: Up to 4 weeks

Population: First and Second Conversion Populations. Only those participants available at the specified time points were analyzed.

Global Improvement Scale (CGI-I) allows the Investigator to rate the participants' global improvement or worsening compared with the condition at Baseline (Day 0), whether or not the change is thought to be due to treatment with study drug. The scale is rated from 1 to 7 (1="Very much improved" to 7="Very much worse"). Typically, a participant with a score of 1 were considered as "Very much improved" and 2 as "Much improved" responder. Positive response was given in terms of worsen to stable or stable to improved.

Outcome measures

Outcome measures
Measure	Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR n=24 Participants Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 1 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS n=24 Participants Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.	Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR n=26 Participants Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 2 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS n=26 Participants Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.	Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR n=15 Participants Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 4 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS n=13 Participants Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
Number of Participants With Positive Scores (Improved) on Clinical Global Impression Improvement Scale (CGI-I) Pre-conversion and One Week Post-conversion Post Coversion 1	14 Participants	12 Participants	10 Participants	9 Participants	6 Participants	6 Participants
Number of Participants With Positive Scores (Improved) on Clinical Global Impression Improvement Scale (CGI-I) Pre-conversion and One Week Post-conversion Post Conversion 2	11 Participants	14 Participants	13 Participants	14 Participants	5 Participants	7 Participants

SECONDARY outcome

Timeframe: Up to 5 weeks

Population: Conversion populations. Only those participants available at the specified time points were analyzed.

The IRLS Rating Scale was developed to measure disease severity for clinical assessment, research, and therapeutic studies an also to show relationship between responses and overall RLS severity. The IRLS Rating Scale is a disease-specific 10-item scale that is based on the IRLSSG consensus of clinical features and associated sleep problems. The investigator asked the participant to rate his/her symptoms for each of the ten questions contained in the IRLS Rating Scale from 0 to 4, with 0 representing the absence of a problem and 4 a very severe problem. The best and worst possible scores are 0 and 40, respectively; higher scores represent a greater severity of symptoms. Changes from pre- to one-week post-conversion in the IRLS rating scale total score was obtained by subtracting the "Week 1" total score from the "Week 2" total score for the first conversion and the "Week 3" total score from the "Week 4" total score for the second conversion.

Outcome measures

Outcome measures
Measure	Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR n=24 Participants Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 1 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS n=24 Participants Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.	Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR n=26 Participants Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 2 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS n=26 Participants Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.	Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR n=15 Participants Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 4 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS n=13 Participants Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
Change From Pre-conversion in International RLS (IRLS) Rating Scale Total Score to One Week Post-conversion Post-Conversion 1	-5.1 Scores on a scale Standard Deviation 8.84	-0.1 Scores on a scale Standard Deviation 7.34	-1.5 Scores on a scale Standard Deviation 6.73	-1.3 Scores on a scale Standard Deviation 7.15	-5.8 Scores on a scale Standard Deviation 6.14	1.2 Scores on a scale Standard Deviation 10.33
Change From Pre-conversion in International RLS (IRLS) Rating Scale Total Score to One Week Post-conversion Post-Conversion 2	-2.9 Scores on a scale Standard Deviation 7.07	-4.8 Scores on a scale Standard Deviation 7.73	-1.6 Scores on a scale Standard Deviation 6.29	-5.2 Scores on a scale Standard Deviation 9.62	0.6 Scores on a scale Standard Deviation 7.28	-2.2 Scores on a scale Standard Deviation 11.58

SECONDARY outcome

Timeframe: Up to 5 weeks

Population: Conversion populations. Only those participants at the indicated conversion were analyzed. The population from Cohort A1 and A2 are pooled to a single arm Cohort A. Similarly populations B1, B2 and C1, C2 are pooled to Cohort B and Cohort C, respectively.

The number of participants with pre- and post- conversion orthostatic systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate values of PCC were summarized. Both conversions (drug and dummy) were considered. High and low values of only orthostatic SBP and DBP of PCC are presented.

Outcome measures

Outcome measures
Measure	Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR n=52 Participants Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 1 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS n=53 Participants Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.	Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR n=30 Participants Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 2 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.	Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 4 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) 2 mg IR to 3 mg CR, pulse, PCC high,pre-conversion	—	1 Participants	—	—	—	—
Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) 1 mg IR to 2 mg CR, SBP, PCC low, pre-conversion	1 Participants	—	—	—	—	—
Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) 1 mg IR to 1 mg IR, SBP, PCC high, post-conversion	1 Participants	—	—	—	—	—
Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) 2 mg IR to 3 mg CR, SBP, PCC high, pre-conversion	—	1 Participants	—	—	—	—
Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) 2 mg IR to 2 mg IR,SBP, PCC high, post-conversion	—	1 Participants	—	—	—	—
Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) 4 mg IR to 4 mg IR, SBP, PCC high, pre-conversion	—	—	1 Participants	—	—	—
Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) 1 mg IR to 2 mg CR, DBP, PCC high, pre-conversion	2 Participants	—	—	—	—	—
Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) 1 mg IR to 2 mg CR, DBP, PCC high, post-conversion	3 Participants	—	—	—	—	—
Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) 1 mg IR to 1 mg IR, DBP, PCC high, pre-conversion	4 Participants	—	—	—	—	—
Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) 1 mg IR to 1 mg IR, DBP, PCC high, post-conversion	2 Participants	—	—	—	—	—
Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) 2 mg IR to 3 mg CR, DBP, PCC high, pre-conversion	—	1 Participants	—	—	—	—
Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) 2 mg IR to 3 mg CR, DBP, PCC high, post-conversion	—	6 Participants	—	—	—	—
Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) 2 mg IR to 2 mg IR, DBP, PCC high, pre-conversion	—	2 Participants	—	—	—	—
Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) 2 mg IR to 2 mg IR, DBP, PCC high, post-conversion	—	2 Participants	—	—	—	—
Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) 4 mg IR to 6 mg CR, DBP, PCC high, post-conversion	—	—	4 Participants	—	—	—
Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) 4 mg IR to 4 mg IR, DBP, PCC high, pre-conversion	—	—	1 Participants	—	—	—
Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) 4 mg IR to 4 mg IR, DBP, PCC high, post-conversion	—	—	2 Participants	—	—	—
Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) 1 mg IR to 1 mg IR, pulse, PCC low,post-conversion	1 Participants	—	—	—	—	—
Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) 2 mg IR to 2 mg IR, pulse,PCC high,post-conversion	—	2 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Up to 5 weeks

Population: Conversion Populations. Only those participants available at the indicated time points were analyzed.

Both conversions 1 and 2 (drug and dummy) were considered for analysis. High and low values of only orthostatic SBP and DBP of PCC are presented. Change from pre-conversion in BP is the value of BP at post-conversion minus the value at pre-conversion. For orthostatic changes (standing minus semi-supine vital signs values), pre-conversion measurements were compared with the post-conversion measurements. Positive values are indicative of less orthostatic decrease in blood pressure. The first conversion relates to the Week 1 visit, with pre- to post-conversion changes computed as "Week 2" values minus the Week 1" values, and the second conversion relates to the Week 3 visit with pre- to post-conversion changes computed as the "Week 4" values minus the Week 3" values.

Outcome measures

Outcome measures
Measure	Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR n=24 Participants Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 1 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS n=24 Participants Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.	Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR n=26 Participants Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 2 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS n=26 Participants Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.	Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR n=15 Participants Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 4 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS n=13 Participants Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion Standing DBP, conversion 1	3.3 Millimeters of mercury (mm of Hg) Standard Deviation 7.56	-3.4 Millimeters of mercury (mm of Hg) Standard Deviation 10.25	4.1 Millimeters of mercury (mm of Hg) Standard Deviation 11.45	-3.2 Millimeters of mercury (mm of Hg) Standard Deviation 7.11	0.6 Millimeters of mercury (mm of Hg) Standard Deviation 6.07	-0.8 Millimeters of mercury (mm of Hg) Standard Deviation 10.08
Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion Semi-supine SBP, conversion 1	-0.8 Millimeters of mercury (mm of Hg) Standard Deviation 12.08	-3.9 Millimeters of mercury (mm of Hg) Standard Deviation 13.78	4.0 Millimeters of mercury (mm of Hg) Standard Deviation 10.81	-7.7 Millimeters of mercury (mm of Hg) Standard Deviation 10.20	-1.2 Millimeters of mercury (mm of Hg) Standard Deviation 7.85	-5.3 Millimeters of mercury (mm of Hg) Standard Deviation 17.84
Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion Standing SBP, conversion 1	2.3 Millimeters of mercury (mm of Hg) Standard Deviation 12.57	-2.9 Millimeters of mercury (mm of Hg) Standard Deviation 13.18	-0.2 Millimeters of mercury (mm of Hg) Standard Deviation 14.19	-4.1 Millimeters of mercury (mm of Hg) Standard Deviation 10.75	0.7 Millimeters of mercury (mm of Hg) Standard Deviation 6.64	-3.9 Millimeters of mercury (mm of Hg) Standard Deviation 11.43
Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion Semi-supine SBP, conversion 2	1.6 Millimeters of mercury (mm of Hg) Standard Deviation 14.51	0.6 Millimeters of mercury (mm of Hg) Standard Deviation 10.33	0.3 Millimeters of mercury (mm of Hg) Standard Deviation 8.91	2.1 Millimeters of mercury (mm of Hg) Standard Deviation 10.73	-2.6 Millimeters of mercury (mm of Hg) Standard Deviation 8.81	-6.2 Millimeters of mercury (mm of Hg) Standard Deviation 19.61
Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion Standing SBP, conversion 2	-0.3 Millimeters of mercury (mm of Hg) Standard Deviation 13.24	3.1 Millimeters of mercury (mm of Hg) Standard Deviation 14.59	3.6 Millimeters of mercury (mm of Hg) Standard Deviation 9.23	1.0 Millimeters of mercury (mm of Hg) Standard Deviation 12.90	0.4 Millimeters of mercury (mm of Hg) Standard Deviation 12.42	-4.9 Millimeters of mercury (mm of Hg) Standard Deviation 16.82
Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion Orhostatic SBP, post-conversion 1	3.2 Millimeters of mercury (mm of Hg) Standard Deviation 10.69	1.0 Millimeters of mercury (mm of Hg) Standard Deviation 10.29	-4.2 Millimeters of mercury (mm of Hg) Standard Deviation 12.12	3.4 Millimeters of mercury (mm of Hg) Standard Deviation 9.95	1.9 Millimeters of mercury (mm of Hg) Standard Deviation 7.76	1.4 Millimeters of mercury (mm of Hg) Standard Deviation 9.69
Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion Orthostatic SBP, post-conversion 2	-1.9 Millimeters of mercury (mm of Hg) Standard Deviation 10.18	2.5 Millimeters of mercury (mm of Hg) Standard Deviation 13.32	3.3 Millimeters of mercury (mm of Hg) Standard Deviation 8.42	-1.0 Millimeters of mercury (mm of Hg) Standard Deviation 9.73	3.0 Millimeters of mercury (mm of Hg) Standard Deviation 13.46	1.3 Millimeters of mercury (mm of Hg) Standard Deviation 12.39
Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion Semi-supine DBP, conversion 1	1.3 Millimeters of mercury (mm of Hg) Standard Deviation 10.96	-2.5 Millimeters of mercury (mm of Hg) Standard Deviation 8.10	2.2 Millimeters of mercury (mm of Hg) Standard Deviation 10.43	-3.5 Millimeters of mercury (mm of Hg) Standard Deviation 6.52	-1.3 Millimeters of mercury (mm of Hg) Standard Deviation 7.61	-1.2 Millimeters of mercury (mm of Hg) Standard Deviation 6.91
Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion Semi-supine DBP, conversion 2	-0.5 Millimeters of mercury (mm of Hg) Standard Deviation 8.67	2.8 Millimeters of mercury (mm of Hg) Standard Deviation 8.80	1.3 Millimeters of mercury (mm of Hg) Standard Deviation 5.53	-0.7 Millimeters of mercury (mm of Hg) Standard Deviation 8.17	0.0 Millimeters of mercury (mm of Hg) Standard Deviation 5.45	-0.7 Millimeters of mercury (mm of Hg) Standard Deviation 13.24
Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion Standing DBP, conversion 2	-2.7 Millimeters of mercury (mm of Hg) Standard Deviation 8.64	2.8 Millimeters of mercury (mm of Hg) Standard Deviation 7.92	0.3 Millimeters of mercury (mm of Hg) Standard Deviation 7.42	0.7 Millimeters of mercury (mm of Hg) Standard Deviation 8.91	-0.3 Millimeters of mercury (mm of Hg) Standard Deviation 6.76	1.8 Millimeters of mercury (mm of Hg) Standard Deviation 12.14
Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion Orthostatic DBP, post-conversion 1	2.0 Millimeters of mercury (mm of Hg) Standard Deviation 7.22	-0.9 Millimeters of mercury (mm of Hg) Standard Deviation 7.11	1.9 Millimeters of mercury (mm of Hg) Standard Deviation 9.70	0.5 Millimeters of mercury (mm of Hg) Standard Deviation 6.37	1.9 Millimeters of mercury (mm of Hg) Standard Deviation 6.53	0.4 Millimeters of mercury (mm of Hg) Standard Deviation 8.17
Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion Orthostatic DBP, post-conversion 2	-2.2 Millimeters of mercury (mm of Hg) Standard Deviation 5.69	0.0 Millimeters of mercury (mm of Hg) Standard Deviation 6.30	-1.1 Millimeters of mercury (mm of Hg) Standard Deviation 6.49	1.4 Millimeters of mercury (mm of Hg) Standard Deviation 7.82	-0.3 Millimeters of mercury (mm of Hg) Standard Deviation 3.31	2.5 Millimeters of mercury (mm of Hg) Standard Deviation 8.37

SECONDARY outcome

Timeframe: Up to 5 weeks

Population: Conversion Populations. Only those participants available at the specified time points were analyzed.

Both conversions 1 and 2 (drug and dummy) were considered for analysis. High and low values of only orthostatic pulse of PCC are presented. Change from pre-conversion in pulse rate is the value of pulse rate at post-conversion minus the value at pre-conversion. For orthostatic changes (standing minus semi-supine vital signs values), pre-conversion measurements were compared with the post-conversion measurements. Positive values are indicative of less orthostatic decrease in pulse. The first conversion relates to the Week 1 visit, with pre- to post-conversion changes computed as "Week 2" values minus the "Week 1" values, and the second conversion relates to the Week 3 visit with pre- to post-conversion changes computed as the "Week 4" values minus the "Week 3" values.

Outcome measures

Outcome measures
Measure	Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR n=26 Participants Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 1 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS n=26 Participants Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.	Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR n=26 Participants Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 2 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS n=27 Participants Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.	Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR n=16 Participants Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 4 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS n=14 Participants Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
Change From Pre-conversion in Pulse Rate to One Week Post-conversion Semi-supine pulse, Conversion 1	-0.1 Beats per minute (bpm) Standard Deviation 7.01	-0.4 Beats per minute (bpm) Standard Deviation 5.38	1.0 Beats per minute (bpm) Standard Deviation 9.42	-0.9 Beats per minute (bpm) Standard Deviation 6.81	-1.5 Beats per minute (bpm) Standard Deviation 6.99	1.2 Beats per minute (bpm) Standard Deviation 8.09
Change From Pre-conversion in Pulse Rate to One Week Post-conversion Standing pulse, Conversion 1	2.4 Beats per minute (bpm) Standard Deviation 8.39	0.3 Beats per minute (bpm) Standard Deviation 9.48	0.0 Beats per minute (bpm) Standard Deviation 10.71	0.7 Beats per minute (bpm) Standard Deviation 8.82	-0.8 Beats per minute (bpm) Standard Deviation 7.84	-0.8 Beats per minute (bpm) Standard Deviation 8.69
Change From Pre-conversion in Pulse Rate to One Week Post-conversion Semi-supine pulse, Conversion 2	-0.7 Beats per minute (bpm) Standard Deviation 8.11	0.3 Beats per minute (bpm) Standard Deviation 6.81	0.2 Beats per minute (bpm) Standard Deviation 9.05	0.3 Beats per minute (bpm) Standard Deviation 8.49	0.6 Beats per minute (bpm) Standard Deviation 5.18	-0.8 Beats per minute (bpm) Standard Deviation 8.97
Change From Pre-conversion in Pulse Rate to One Week Post-conversion Standing pulse, Conversion 2	-0.4 Beats per minute (bpm) Standard Deviation 9.36	0.3 Beats per minute (bpm) Standard Deviation 8.95	1.4 Beats per minute (bpm) Standard Deviation 12.77	0.9 Beats per minute (bpm) Standard Deviation 9.01	0.9 Beats per minute (bpm) Standard Deviation 5.99	1.5 Beats per minute (bpm) Standard Deviation 8.53
Change From Pre-conversion in Pulse Rate to One Week Post-conversion Post-Conversion 1	2.5 Beats per minute (bpm) Standard Deviation 8.80	0.7 Beats per minute (bpm) Standard Deviation 8.38	-1.0 Beats per minute (bpm) Standard Deviation 6.72	1.6 Beats per minute (bpm) Standard Deviation 8.29	0.7 Beats per minute (bpm) Standard Deviation 4.59	-2.0 Beats per minute (bpm) Standard Deviation 7.56
Change From Pre-conversion in Pulse Rate to One Week Post-conversion Post-Conversion 2	0.3 Beats per minute (bpm) Standard Deviation 9.27	0.0 Beats per minute (bpm) Standard Deviation 6.78	1.2 Beats per minute (bpm) Standard Deviation 9.87	0.6 Beats per minute (bpm) Standard Deviation 6.24	0.3 Beats per minute (bpm) Standard Deviation 6.07	2.2 Beats per minute (bpm) Standard Deviation 5.37

SECONDARY outcome

Timeframe: Up to 5 weeks

Population: Conversion population. Only those participants available at the time of conversion were analyzed.

Blood pressure (both systolic and diastolic) measurements were made just prior to the first dose of study medication ('evening' dose, ropinirole CR-RLS or matching placebo) and then every hour afterwards up to bedtime (when the device was removed). The changes for the first conversion were calculated as the "post evening dose" values minus the "pre evening dose" values at the Week 1 visit and the changes for the second conversion were the "post evening dose" values minus the "pre evening dose" values at the Week 3 visit.

Outcome measures

Outcome measures
Measure	Ropinirole Cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR n=24 Participants Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 1 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS n=24 Participants Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.	Ropinirole Cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR n=26 Participants Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 2 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS n=26 Participants Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.	Ropinirole Cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR n=15 Participants Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 4 mg IR at bedtime and continued to receive the same till the end of Week 4.	Ropinirole Cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS n=13 Participants Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure SBP, conversion 1, <30 minutes	-20.0 mmHg Standard Deviation NA only one participant was analyzed, hence SD was not calculated.	—	-20.0 mmHg Standard Deviation NA only one participant was analyzed, hence SD was not calculated.	-6.0 mmHg Standard Deviation NA only one participant was analyzed, hence SD was not calculated.	—	—
Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure SBP, conversion 1, 1 hour	-8.0 mmHg Standard Deviation 10.64	-6.4 mmHg Standard Deviation 14.14	-10.6 mmHg Standard Deviation 9.86	-1.0 mmHg Standard Deviation 10.96	-6.3 mmHg Standard Deviation 8.35	-5.0 mmHg Standard Deviation 2.83
Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure SBP, conversion 1, 2 hours	-12.9 mmHg Standard Deviation 14.10	0.1 mmHg Standard Deviation 16.83	-9.1 mmHg Standard Deviation 6.84	-4.3 mmHg Standard Deviation 10.35	-8.0 mmHg Standard Deviation 7.19	7.5 mmHg Standard Deviation 4.95
Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure SBP, conversion 1, 3 hours	-10.8 mmHg Standard Deviation 13.57	1.3 mmHg Standard Deviation 12.46	-15.9 mmHg Standard Deviation 13.71	-3.0 mmHg Standard Deviation 9.49	-7.4 mmHg Standard Deviation 8.82	-4.5 mmHg Standard Deviation 0.71
Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure SBP, conversion 1, 4 hours	-11.0 mmHg Standard Deviation 7.26	-9.9 mmHg Standard Deviation 17.40	-12.8 mmHg Standard Deviation 15.82	-10.3 mmHg Standard Deviation 7.74	-12.8 mmHg Standard Deviation 12.89	3.5 mmHg Standard Deviation 2.12
Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure SBP, conversion 1, 5 hours	-8.6 mmHg Standard Deviation 7.70	-10.6 mmHg Standard Deviation 20.86	-15.5 mmHg Standard Deviation 13.77	-8.3 mmHg Standard Deviation 5.91	-15.5 mmHg Standard Deviation 6.36	14.0 mmHg Standard Deviation NA only one participant was analyzed, hence SD was not calculated.
Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure SBP, conversion 1, 6 hours	-14.3 mmHg Standard Deviation 4.51	-11.0 mmHg Standard Deviation NA only one participant was analyzed, hence SD was not calculated.	-9.0 mmHg Standard Deviation 21.38	-11.0 mmHg Standard Deviation 25.46	—	0.0 mmHg Standard Deviation NA only one participant was analyzed, hence SD was not calculated.
Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure SBP, conversion 2, <30 minutes	—	-15.0 mmHg Standard Deviation NA only one participant was analyzed, hence SD was not calculated.	—	—	-5.5 mmHg Standard Deviation 4.95	12.0 mmHg Standard Deviation NA only one participant was analyzed, hence SD was not calculated.
Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure SBP, conversion 2, 1 hour	-5.4 mmHg Standard Deviation 11.35	-1.5 mmHg Standard Deviation 13.81	-1.6 mmHg Standard Deviation 9.80	-1.3 mmHg Standard Deviation 13.47	0.6 mmHg Standard Deviation 10.71	-2.8 mmHg Standard Deviation 3.77
Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure SBP, conversion 2, 2 hours	2.6 mmHg Standard Deviation 19.23	-10.6 mmHg Standard Deviation 17.44	2.0 mmHg Standard Deviation 6.62	-0.6 mmHg Standard Deviation 16.33	-0.3 mmHg Standard Deviation 6.56	-5.0 mmHg Standard Deviation 10.71
Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure SBP, conversion 2, 3 hours	-12.0 mmHg Standard Deviation 13.51	-4.6 mmHg Standard Deviation 11.64	-3.3 mmHg Standard Deviation 12.01	0.7 mmHg Standard Deviation 14.13	-5.0 mmHg Standard Deviation 9.49	-4.3 mmHg Standard Deviation 8.81
Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure SBP, conversion 2, 4 hours	1.0 mmHg Standard Deviation 10.61	-6.8 mmHg Standard Deviation 4.27	-2.6 mmHg Standard Deviation 14.04	6.4 mmHg Standard Deviation 4.04	0.3 mmHg Standard Deviation 13.41	-7.3 mmHg Standard Deviation 5.56
Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure SBP, conversion 2, 5 hours	-9.0 mmHg Standard Deviation 7.07	-11.0 mmHg Standard Deviation 11.36	-0.5 mmHg Standard Deviation 13.10	3.7 mmHg Standard Deviation 9.45	-18.0 mmHg Standard Deviation 8.54	9.0 mmHg Standard Deviation NA only one participant was analyzed, hence SD was not calculated
Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure SBP, conversion 2, 6 hours	-8.0 mmHg Standard Deviation NA only one participant was analyzed, hence SD was not calculated.	3.0 mmHg Standard Deviation NA only one participant was analyzed, hence SD was not calculated.	-0.6 mmHg Standard Deviation 14.84	-7.0 mmHg Standard Deviation NA only one participant was analyzed, hence SD was not calculated.	-20.5 mmHg Standard Deviation 7.78	—
Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure DBP, conversion 1, <30 minutes	-6.0 mmHg Standard Deviation NA only one participant was analyzed, hence SD was not calculated.	—	-2.0 mmHg Standard Deviation NA only one participant was analyzed, hence SD was not calculated.	-2.0 mmHg Standard Deviation NA only one participant was analyzed, hence SD was not calculated.	—	—
Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure DBP, conversion 1, 1 hour	-4.9 mmHg Standard Deviation 6.69	-4.7 mmHg Standard Deviation 10.37	-1.6 mmHg Standard Deviation 9.46	-1.5 mmHg Standard Deviation 9.64	-5.4 mmHg Standard Deviation 8.55	-5.0 mmHg Standard Deviation 1.41
Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure DBP, conversion 1, 2 hours	-9.0 mmHg Standard Deviation 13.59	-2.9 mmHg Standard Deviation 10.53	-0.4 mmHg Standard Deviation 7.32	-4.8 mmHg Standard Deviation 6.71	-3.4 mmHg Standard Deviation 7.25	6.0 mmHg Standard Deviation 4.24
Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure DBP, conversion 1, 3 hours	-4.9 mmHg Standard Deviation 10.89	-1.9 mmHg Standard Deviation 9.72	-8.1 mmHg Standard Deviation 11.26	-9.2 mmHg Standard Deviation 9.14	-5.4 mmHg Standard Deviation 7.96	-5.0 mmHg Standard Deviation 8.49
Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure DBP, conversion 1, 4 hours	-5.3 mmHg Standard Deviation 6.82	-9.7 mmHg Standard Deviation 10.74	-8.4 mmHg Standard Deviation 8.41	-5.1 mmHg Standard Deviation 8.11	-4.0 mmHg Standard Deviation 10.89	4.0 mmHg Standard Deviation 4.24
Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure DBP, conversion 1, 5 hours	-1.2 mmHg Standard Deviation 2.28	-8.4 mmHg Standard Deviation 14.13	-10.0 mmHg Standard Deviation 9.42	-5.8 mmHg Standard Deviation 9.29	-14.5 mmHg Standard Deviation 9.19	0.0 mmHg Standard Deviation 0.0
Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure DBP, conversion 1, 6 hours	-9.0 mmHg Standard Deviation 4.36	-23.0 mmHg Standard Deviation NA only one participant was analyzed, hence SD was not calculated.	-3.3 mmHg Standard Deviation 2.08	-6.0 mmHg Standard Deviation 9.90	—	8.0 mmHg Standard Deviation NA only one participant was analyzed, hence SD was not calculated.
Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure DBP, conversion 2, <30 minutes	—	-10.0 mmHg Standard Deviation NA only one participant was analyzed, hence SD was not calculated.	—	—	-4.5 mmHg Standard Deviation 0.71	20.0 mmHg Standard Deviation NA only one participant was analyzed, hence SD was not calculated.
Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure DBP, conversion 2, 1 hour	-0.4 mmHg Standard Deviation 12.70	-5.1 mmHg Standard Deviation 10.37	-1.9 mmHg Standard Deviation 8.50	0.9 mmHg Standard Deviation 12.86	0.2 mmHg Standard Deviation 8.97	3.8 mmHg Standard Deviation 7.69
Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure DBP, conversion 2, 2 hours	4.6 mmHg Standard Deviation 12.42	-9.6 mmHg Standard Deviation 11.90	-3.3 mmHg Standard Deviation 11.19	0.9 mmHg Standard Deviation 15.45	-4.4 mmHg Standard Deviation 8.62	-10.5 mmHg Standard Deviation 9.15
Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure DBP, conversion 2, 3 hours	2.4 mmHg Standard Deviation 20.42	-5.8 mmHg Standard Deviation 7.12	-10.5 mmHg Standard Deviation 14.16	-1.4 mmHg Standard Deviation 10.67	-7.2 mmHg Standard Deviation 5.71	-4.5 mmHg Standard Deviation 7.59
Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure DBP, conversion 2, 4 hours	0.8 mmHg Standard Deviation 17.11	-8.3 mmHg Standard Deviation 10.14	-4.6 mmHg Standard Deviation 17.66	-1.0 mmHg Standard Deviation 10.51	-3.8 mmHg Standard Deviation 7.19	-7.8 mmHg Standard Deviation 7.97
Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure DBP, conversion 2, 5 hours	-8.0 mmHg Standard Deviation 0.00	-2.3 mmHg Standard Deviation 13.61	-7.5 mmHg Standard Deviation 13.71	2.0 mmHg Standard Deviation 16.09	-17.0 mmHg Standard Deviation 5.20	8.0 mmHg Standard Deviation NA only one participant was analyzed, hence no data.
Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure DBP, conversion 2, 6 hours	-7.0 mmHg Standard Deviation NA only one participant was analyzed, hence SD was not calculated.	-10.0 mmHg Standard Deviation NA only one participant was analyzed, hence SD was not calculated.	-5.8 mmHg Standard Deviation 20.03	-15.0 mmHg Standard Deviation NA only one participant was analyzed, hence SD was not calculated.	-15.0 mmHg Standard Deviation 1.41	—

Adverse Events

Ropinirole Cohort A

Serious events: 1 serious events

Other events: 37 other events

Deaths: 0 deaths

Ropinirole Cohort B

Serious events: 0 serious events

Other events: 38 other events

Deaths: 0 deaths

Ropinirole Cohort C

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ropinirole Cohort A n=52 participants at risk It consisted of two dosing groups: A1 and A2. In cohort A1, participants received Placebo in the evening and Ropinirole 1mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 1 mg IR at bedtime and continued to receive the same till the end of Week 4. In cohort A2, participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.	Ropinirole Cohort B n=53 participants at risk It consisted of two dosing groups: B1 and B2. In cohort B1, participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 2 mg IR at bedtime and continued to receive the same till the end of Week 4. In cohort B2, participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.	Ropinirole Cohort C n=30 participants at risk It consisted of two dosing groups: C1 and C2. In cohort C1, participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 4 mg IR at bedtime and continued to receive the same till the end of Week 4. In cohort C2, participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4.
Cardiac disorders Palpitations	1.9% 1/52 • Up to 5 weeks Conversion population was used. AEs and SAEs are also reported for participants who were included in pre and post conversion population. AEs were counted under the formulation the participant was taking, when the AE began. Hence, AEs data were reported formulation wise (Formulation A, B and C).	0.00% 0/53 • Up to 5 weeks Conversion population was used. AEs and SAEs are also reported for participants who were included in pre and post conversion population. AEs were counted under the formulation the participant was taking, when the AE began. Hence, AEs data were reported formulation wise (Formulation A, B and C).	0.00% 0/30 • Up to 5 weeks Conversion population was used. AEs and SAEs are also reported for participants who were included in pre and post conversion population. AEs were counted under the formulation the participant was taking, when the AE began. Hence, AEs data were reported formulation wise (Formulation A, B and C).

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER