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This is a multi-center, Phase III study to evaluate the safety and tolerability of proposed dose conversion recommendations for RLS subjects converting from ropinirole immediate release to ropinirole controlled-release for RLS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropinirole cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | Experimental | 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 | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropinirole IR 1 mg | Drug | Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 1.0mg of active drug substance. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) Post-conversion From Ropinirole IR to Ropinirole CR Over Period | 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. | Up to 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Discontinuing the Drug Due to AEs Post Conversion From Ropinirole IR to Ropinirole CR-RLS | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Laguna Hills | California | 82653 | United States | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| ROX104805 | Individual Participant Data Set | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
This study was conducted from 14 November 2005 till 21 September 2006 across 27 centers in the United States (US).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Ropinirole cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | Experimental | 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 | Experimental | 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 | Experimental | 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. |
|
|
| Ropinirole IR 2 mg | Drug | Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 2.0mg of active drug substance. |
|
| Ropinirole IR 1 mg Placebo | Drug | Ropinirole IR (SKF-101468) placebo will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing matching placebo tablets of 1 mg. |
|
| Ropinirole IR 2 mg Placebo | Drug | Ropinirole IR (SKF-101468) placebo will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing matching placebo tablets of 2 mg. |
|
| Ropinirole CR 2 mg | Drug | Ropinirole CR Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 2mg of the active drug substance. |
|
| Ropinirole CR 3 mg | Drug | Ropinirole CR Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 3mg of the active drug substance. |
|
| Ropinirole CR 2 mg Placebo | Drug | Ropinirole CR placebo Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing matching placebo tablets of 2 mg. |
|
| Ropinirole CR 3 mg Placebo | Drug | Ropinirole CR placebo Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing matching placebo tablets of 3 mg. |
|
| Up to 5 weeks |
| Number of Participants With SAEs and Severity of AEs | 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. | Up to 5 weeks |
| Number of Participants With Positive Scores (Improved) on Clinical Global Impression Improvement Scale (CGI-I) Pre-conversion and One Week Post-conversion | 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. | Up to 4 weeks |
| Change From Pre-conversion in International RLS (IRLS) Rating Scale Total Score to One Week Post-conversion | 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. | Up to 5 weeks |
| Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) | 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. | Up to 5 weeks |
| Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | 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. | Up to 5 weeks |
| Change From Pre-conversion in Pulse Rate to One Week Post-conversion | 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. | Up to 5 weeks |
| Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | 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. | Up to 5 weeks |
| Oxnard |
| California |
| 93030 |
| United States |
| GSK Investigational Site | Pasadena | California | 91106 | United States |
| GSK Investigational Site | Reseda | California | 91355 | United States |
| GSK Investigational Site | Boca Raton | Florida | 33486 | United States |
| GSK Investigational Site | St. Petersburg | Florida | 33701 | United States |
| GSK Investigational Site | Tampa | Florida | 33609 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30342 | United States |
| GSK Investigational Site | Oak Brook | Illinois | 60523 | United States |
| GSK Investigational Site | Lenexa | Kansas | 66214 | United States |
| GSK Investigational Site | Baton Rouge | Louisiana | 70808 | United States |
| GSK Investigational Site | Springfield | Massachusetts | 01104 | United States |
| GSK Investigational Site | Bingham Farms | Michigan | 48025 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 89119 | United States |
| GSK Investigational Site | Lebanon | New Hampshire | 03766 | United States |
| GSK Investigational Site | Cherry Hill | New Jersey | 08003 | United States |
| GSK Investigational Site | Toms River | New Jersey | 08755 | United States |
| GSK Investigational Site | New York | New York | 10021 | United States |
| GSK Investigational Site | Plainview | New York | 11803 | United States |
| GSK Investigational Site | Greenville | North Carolina | 27834 | United States |
| GSK Investigational Site | Dayton | Ohio | 46432 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| GSK Investigational Site | Medford | Oregon | 97504-8456 | United States |
| GSK Investigational Site | Portland | Oregon | 97210 | United States |
| GSK Investigational Site | Columbia | South Carolina | 29201 | United States |
| GSK Investigational Site | Dallas | Texas | 75213 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Tacoma | Washington | 98405 | United States |
| GSK Investigational Site | Walla Walla | Washington | 99362 | United States |
| GSK Investigational Site | Madison | Wisconsin | 53715 | United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| ROX104805 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ROX104805 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ROX104805 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ROX104805 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ROX104805 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ROX104805 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Safety population included all participants who entered into the study and who received at least one dose of the double-blind medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) Post-conversion From Ropinirole IR to Ropinirole CR Over Period | 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. | Conversion population. Only those participants available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Up to 5 weeks |
|
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| Secondary | Number of Participants Discontinuing the Drug Due to AEs Post Conversion From Ropinirole IR to Ropinirole CR-RLS | 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. | Conversion population. Only those participants available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Up to 5 weeks |
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| Secondary | Number of Participants With SAEs and Severity of AEs | 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. | Conversion population. Only those participants available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Up to 5 weeks |
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Positive Scores (Improved) on Clinical Global Impression Improvement Scale (CGI-I) Pre-conversion and One Week Post-conversion | 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. | First and Second Conversion Populations. Only those participants available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Up to 4 weeks |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Pre-conversion in International RLS (IRLS) Rating Scale Total Score to One Week Post-conversion | 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. | Conversion populations. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Scores on a scale | Up to 5 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With pre-and One Week Post-conversion Values of Vital Signs of Potential Clinical Concern (PCC) | 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. | 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. | Posted | Count of Participants | Participants | Up to 5 weeks |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Pre-conversion in Systolic and Diastolic Orthostatic SBP and DBP to One Week Post-conversion | 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. | Conversion Populations. Only those participants available at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | Millimeters of mercury (mm of Hg) | Up to 5 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Pre-conversion in Pulse Rate to One Week Post-conversion | 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. | Conversion Populations. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Beats per minute (bpm) | Up to 5 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Pre-conversion to Post-conversion in Ambulatory Blood Pressure | 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. | Conversion population. Only those participants available at the time of conversion were analyzed. | Posted | Mean | Standard Deviation | mmHg | Up to 5 weeks |
|
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).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ropinirole Cohort A | 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. | 0 | 52 | 1 | 52 | 37 | 52 |
| EG001 | Ropinirole Cohort B | 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. | 0 | 53 | 0 | 53 | 38 | 53 |
| EG002 | Ropinirole Cohort C | 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. | 0 | 30 | 0 | 30 | 19 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA version 9.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 9.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA version 9.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA version 9.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 9.1 | Systematic Assessment |
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| Insomnia | Nervous system disorders | MedDRA version 9.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 9.1 | Systematic Assessment |
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| Restless legs syndrome | Musculoskeletal and connective tissue disorders | MedDRA version 9.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 9.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA version 9.1 | Systematic Assessment |
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| Stomach discomfort | Gastrointestinal disorders | MedDRA version 9.1 | Systematic Assessment |
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| Paresthesia | Nervous system disorders | MedDRA version 9.1 | Systematic Assessment |
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| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 9.1 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA version 9.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA version 9.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA version 9.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA version 9.1 | Systematic Assessment |
| |
| Hypoaesthesia | Skin and subcutaneous tissue disorders | MedDRA version 9.1 | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA version 9.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 9.1 | Systematic Assessment |
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| Sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 9.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D020447 | Parasomnias |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C046649 | ropinirole |
Not provided
Not provided
Not provided
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG005 | 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. |
|
| Post-conversion 2 |
|
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| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
|
|
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.
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
|
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
|
|
| Ropinirole Cohort B |
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. |
| OG002 | Ropinirole Cohort C | 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. |
|
|
| 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
|
|
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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
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