Trial Outcomes & Findings for Clinical Evaluation of Ropinirole IR (Immediate Release) Tablets in Patients Who Are Diagnosed With Symptomatic Restless Legs Syndrome (RLS) Associated With Chronic Kidney Disease (CKD) Managed With Haemodialysis (Including Haemofiltration and Haemodiafiltration) (NCT NCT00996944)
NCT ID: NCT00996944
Last Updated: 2018-08-10
Results Overview
The IRLS rating scale is an investigator-rated scale consisting of 10 questions with a choice of 5 responses each. These responses are numerically scored from 0 (the least severe response) to 4 (the most severe response). The IRLS rating scale total score is calculated by summing the individual response scores. The highest possible score is 40, which represents the most severe RLS; the lowest possible score is 0, which represents an absence of RLS. A total of 17 participants were prematurely withdrawn from the study before Week 12.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
Week 0 and Week 12
Results posted on
2018-08-10
Participant Flow
This study was prematurely terminated after 5 months had passed since its initiation, because GlaxoSmithKline (GSK) concluded that it was impossible to recruit sufficient participants within a reasonable timeframe. In this study, no participants had completed. The maximum duration was 24 weeks plus follow-up (up to Week 64).
Participant milestones
| Measure |
Ropinirole IR-Ropinirole IR
Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of investigational product (IP) was upward titrated from 0.25 milligrams (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed Clinical Global Impression-Improvement \[CGI-I\]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
|
Placebo-Ropinirole IR
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
|
|---|---|---|
|
Double-blind Treatment Period
STARTED
|
22
|
12
|
|
Double-blind Treatment Period
COMPLETED
|
12
|
5
|
|
Double-blind Treatment Period
NOT COMPLETED
|
10
|
7
|
|
Long-term Treatment Period
STARTED
|
12
|
5
|
|
Long-term Treatment Period
COMPLETED
|
0
|
0
|
|
Long-term Treatment Period
NOT COMPLETED
|
12
|
5
|
Reasons for withdrawal
| Measure |
Ropinirole IR-Ropinirole IR
Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of investigational product (IP) was upward titrated from 0.25 milligrams (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed Clinical Global Impression-Improvement \[CGI-I\]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
|
Placebo-Ropinirole IR
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
|
|---|---|---|
|
Double-blind Treatment Period
Adverse Event
|
2
|
1
|
|
Double-blind Treatment Period
Protocol Violation
|
1
|
0
|
|
Double-blind Treatment Period
Study Closed/Terminated
|
6
|
5
|
|
Double-blind Treatment Period
Withdrawal by Subject
|
1
|
1
|
|
Long-term Treatment Period
Study Closed/Terminated
|
12
|
5
|
Baseline Characteristics
Clinical Evaluation of Ropinirole IR (Immediate Release) Tablets in Patients Who Are Diagnosed With Symptomatic Restless Legs Syndrome (RLS) Associated With Chronic Kidney Disease (CKD) Managed With Haemodialysis (Including Haemofiltration and Haemodiafiltration)
Baseline characteristics by cohort
| Measure |
Ropinirole IR-Ropinirole IR
n=22 Participants
Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of investigational product (IP) was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed Clinical Global Impression - Improvement \[CGI-I\]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
|
Placebo-Ropinirole IR
n=12 Participants
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.5 Years
STANDARD_DEVIATION 11.39 • n=93 Participants
|
53.8 Years
STANDARD_DEVIATION 10.90 • n=4 Participants
|
53.6 Years
STANDARD_DEVIATION 11.06 • n=27 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
22 participants
n=93 Participants
|
12 participants
n=4 Participants
|
34 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Not Asian - Japanese Heritage
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
|
Age at Onset of Restless Legs Syndrome
|
48.9 years
STANDARD_DEVIATION 11.24 • n=93 Participants
|
49.4 years
STANDARD_DEVIATION 10.12 • n=4 Participants
|
49.1 years
STANDARD_DEVIATION 10.71 • n=27 Participants
|
|
Duration of Dialysis
|
7.41 years
STANDARD_DEVIATION 5.537 • n=93 Participants
|
6.08 years
STANDARD_DEVIATION 5.274 • n=4 Participants
|
6.94 years
STANDARD_DEVIATION 5.403 • n=27 Participants
|
PRIMARY outcome
Timeframe: Week 0 and Week 12Population: Full Analysis Set (FAS): participants who were progressed to the treatment phase, but excluding those who did not have the target indication, those who had not received at least one dose of the investigational product, and those who did not have any measured efficacy data after initiation of the study treatment.
The IRLS rating scale is an investigator-rated scale consisting of 10 questions with a choice of 5 responses each. These responses are numerically scored from 0 (the least severe response) to 4 (the most severe response). The IRLS rating scale total score is calculated by summing the individual response scores. The highest possible score is 40, which represents the most severe RLS; the lowest possible score is 0, which represents an absence of RLS. A total of 17 participants were prematurely withdrawn from the study before Week 12.
Outcome measures
| Measure |
Ropinirole IR-Ropinirole IR
n=22 Participants
Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed Clinical Global Impression - Improvement \[CGI-I\]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
|
Placebo-Ropinirole IR
n=12 Participants
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
|
|---|---|---|
|
International Restless Legs Syndrome (IRLS) Rating Scale Total Score at Week 0 and Week 12
Week 0, n=22, 12
|
26.0 units on a scale
Standard Deviation 5.51
|
24.0 units on a scale
Standard Deviation 3.64
|
|
International Restless Legs Syndrome (IRLS) Rating Scale Total Score at Week 0 and Week 12
Week 12, n=12, 5
|
15.9 units on a scale
Standard Deviation 9.97
|
9.2 units on a scale
Standard Deviation 5.26
|
PRIMARY outcome
Timeframe: DBT WD (up to Week 12)Population: Full Analysis Set (FAS): participants who were progressed to the treatment phase, but excluding those who did not have the target indication, those who had not received at least one dose of the investigational product, and those who did not have any measured efficacy data after initiation of the study treatment.
The IRLS rating scale is an investigator-rated scale consisting of 10 questions with a choice of 5 responses each. These responses are numerically scored from 0 (the least severe response) to 4 (the most severe response). The IRLS rating scale total score is calculated by summing the individual response scores. The highest possible score is 40, which represents the most severe RLS; the lowest possible score is 0, which represents an absence of RLS. A total of 17 participants were prematurely withdrawn from the study before Week 12, and 2 participants had missing DBT WD data.
Outcome measures
| Measure |
Ropinirole IR-Ropinirole IR
n=8 Participants
Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed Clinical Global Impression - Improvement \[CGI-I\]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
|
Placebo-Ropinirole IR
n=7 Participants
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
|
|---|---|---|
|
IRLS Rating Scale Total Score for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)
|
20.3 units on a scale
Standard Deviation 10.77
|
16.3 units on a scale
Standard Deviation 10.42
|
SECONDARY outcome
Timeframe: LONG WD (up to Week 64)Population: FAS. One participant in each group had no measurement data and thus was not included in the analysis. These two participants were withdrawn from the study without receiving the IP in the long-term treatment period.
The IRLS rating scale is an investigator-rated scale consisting of 10 questions with a choice of 5 responses each. These responses are numerically scored from 0 (the least severe response) to 4 (the most severe response). The IRLS rating scale total score is calculated by summing the individual response scores. The highest possible score is 40, which represents the most severe RLS; the lowest possible score is 0, which represents an absence of RLS.
Outcome measures
| Measure |
Ropinirole IR-Ropinirole IR
n=11 Participants
Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed Clinical Global Impression - Improvement \[CGI-I\]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
|
Placebo-Ropinirole IR
n=4 Participants
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
|
|---|---|---|
|
IRLS Rating Scale Total Score for Participants Who Withdrew in the Long-term Treatment Period (LONG WD)
|
18.0 units on a scale
Standard Deviation 12.26
|
16.5 units on a scale
Standard Deviation 4.12
|
SECONDARY outcome
Timeframe: Week 12Population: FAS. Participants withdrawn from the study before Week 12 were not included in the analysis.
The CGI-I assesses the participant's improvement or worsening of RLS from baseline with the following eight grades: 0 = Not Assessed, 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse.
Outcome measures
| Measure |
Ropinirole IR-Ropinirole IR
n=12 Participants
Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed Clinical Global Impression - Improvement \[CGI-I\]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
|
Placebo-Ropinirole IR
n=5 Participants
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
|
|---|---|---|
|
Number of Participants With the Indicated Clinical Global Impression-Improvement (CGI-I) Scores at Week 12
Not Assessed
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Clinical Global Impression-Improvement (CGI-I) Scores at Week 12
Very Much Improved
|
2 participants
|
3 participants
|
|
Number of Participants With the Indicated Clinical Global Impression-Improvement (CGI-I) Scores at Week 12
Much Improved
|
3 participants
|
1 participants
|
|
Number of Participants With the Indicated Clinical Global Impression-Improvement (CGI-I) Scores at Week 12
Minimally Improved
|
4 participants
|
1 participants
|
|
Number of Participants With the Indicated Clinical Global Impression-Improvement (CGI-I) Scores at Week 12
No Change
|
2 participants
|
0 participants
|
|
Number of Participants With the Indicated Clinical Global Impression-Improvement (CGI-I) Scores at Week 12
Minimally Worse
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Clinical Global Impression-Improvement (CGI-I) Scores at Week 12
Much Worse
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Clinical Global Impression-Improvement (CGI-I) Scores at Week 12
Very Much Worse
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: DBT WD (up to Week 12)Population: FAS. Participants with missing DBT WD data were not included in the analysis.
The CGI-I assesses the participant's improvement or worsening of RLS from baseline with the following eight grades: 0 = Not Assessed, 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse.
Outcome measures
| Measure |
Ropinirole IR-Ropinirole IR
n=8 Participants
Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed Clinical Global Impression - Improvement \[CGI-I\]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
|
Placebo-Ropinirole IR
n=7 Participants
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
|
|---|---|---|
|
Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)
Not Assessed
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)
Very Much Improved
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)
Much Improved
|
3 participants
|
2 participants
|
|
Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)
Minimally Improved
|
2 participants
|
3 participants
|
|
Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)
No Change
|
2 participants
|
0 participants
|
|
Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)
Minimally Worse
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)
Much Worse
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)
Very Much Worse
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: LONG WD (up to Week 64)Population: FAS. Participants with no measurement data in the long-term treatment period because of their premature withdrawal without receiving the IP in that period were not included in the analysis.
The CGI-I assesses the participant's improvement or worsening of RLS from baseline with the following eight grades: 0 = Not Assessed, 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse.
Outcome measures
| Measure |
Ropinirole IR-Ropinirole IR
n=11 Participants
Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed Clinical Global Impression - Improvement \[CGI-I\]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
|
Placebo-Ropinirole IR
n=4 Participants
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
|
|---|---|---|
|
Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)
Not Assessed
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)
Very Much Improved
|
3 participants
|
0 participants
|
|
Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)
Much Improved
|
1 participants
|
2 participants
|
|
Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)
Minimally Improved
|
4 participants
|
2 participants
|
|
Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)
No Change
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)
Minimally Worse
|
3 participants
|
0 participants
|
|
Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)
Much Worse
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)
Very Much Worse
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 0 and Week 12Population: FAS. Participants withdrawn from the study before Week 12 were not included in the analysis.
The RLSQOL questionnaire is a participant-rated questionnaire designed to assess the impact of RLS on the lives of participants. It consists of 18 items, 10 of which contribute to a single summary score (overall life impact). The response for each item is coded from 1 to 5, with 1 representing the best quality of life and 5 representing the worst quality of life. The lowest possible overall life impact score is 0, and the highest possible overall life impact score is 100. The score of 100 represents the best possible quality of life.
Outcome measures
| Measure |
Ropinirole IR-Ropinirole IR
n=22 Participants
Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed Clinical Global Impression - Improvement \[CGI-I\]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
|
Placebo-Ropinirole IR
n=12 Participants
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
|
|---|---|---|
|
Johns Hopkins Restless Legs Syndrome Quality of Life (RLSQOL) Questionnaire Overall Life Impact Score at Week 0 and Week 12
Week 0, n=22, 12
|
77.50 units on a scale
Standard Deviation 15.736
|
73.13 units on a scale
Standard Deviation 10.287
|
|
Johns Hopkins Restless Legs Syndrome Quality of Life (RLSQOL) Questionnaire Overall Life Impact Score at Week 0 and Week 12
Week 12, n=12, 5
|
85.63 units on a scale
Standard Deviation 14.852
|
90.50 units on a scale
Standard Deviation 7.786
|
SECONDARY outcome
Timeframe: DBT WD (up to Week 12)Population: FAS. Participants with missing DBT WD data were not included in the analysis.
The RLSQOL questionnaire is a participant-rated questionnaire designed to assess the impact of RLS on the lives of participants. It consists of 18 items, 10 of which contribute to a single summary score (overall life impact). The response for each item is coded from 1 to 5, with 1 representing the best quality of life and 5 representing the worst quality of life. The lowest possible overall life impact score is 0, and the highest possible overall life impact score is 100. The score of 100 represents the best possible quality of life.
Outcome measures
| Measure |
Ropinirole IR-Ropinirole IR
n=8 Participants
Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed Clinical Global Impression - Improvement \[CGI-I\]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
|
Placebo-Ropinirole IR
n=7 Participants
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
|
|---|---|---|
|
Johns Hopkins RLSQOL Questionnaire Overall Life Impact Score for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)
|
75.00 units on a scale
Standard Deviation 12.956
|
84.64 units on a scale
Standard Deviation 9.835
|
SECONDARY outcome
Timeframe: LONG WD (up to Week 64)Population: FAS. Participants with no measurement data in the long-term treatment period because of their premature withdrawal without receiving the IP in that period were not included in the analysis.
The RLSQOL questionnaire is a participant-rated questionnaire designed to assess the impact of RLS on the lives of participants. It consists of 18 items, 10 of which contribute to a single summary score (overall life impact). The response for each item is coded from 1 to 5, with 1 representing the best quality of life and 5 representing the worst quality of life. The lowest possible overall life impact score is 0, and the highest possible overall life impact score is 100. The score of 100 represents the best possible quality of life.
Outcome measures
| Measure |
Ropinirole IR-Ropinirole IR
n=11 Participants
Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed Clinical Global Impression - Improvement \[CGI-I\]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
|
Placebo-Ropinirole IR
n=4 Participants
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
|
|---|---|---|
|
Johns Hopkins RLSQOL Questionnaire Overall Life Impact Score for Participants Who Withdrew in the Long-term Treatment Period (LONG WD)
|
79.32 units on a scale
Standard Deviation 27.502
|
87.50 units on a scale
Standard Deviation 11.365
|
SECONDARY outcome
Timeframe: Week 0 and Week 12Population: FAS. Participants withdrawn from the study before Week 12 were not included in the analysis.
The PSQI consists of the following 7 domains: sleep quality, duration getting to sleep, sleep duration, sleep adequacy, sleep disturbance, use of sleeping pill, and somnolence. These domains are numerically scored from 0 to 3, with 0 representing the least severe response and 3 representing the most severe response. The PSQI total score is calculated by summing the individual domain scores. The highest possible score is 21, which represents the most disturbances in sleep quality; the lowest possible score is 0, which represents an absence of disturbances in sleep quality.
Outcome measures
| Measure |
Ropinirole IR-Ropinirole IR
n=22 Participants
Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed Clinical Global Impression - Improvement \[CGI-I\]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
|
Placebo-Ropinirole IR
n=12 Participants
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
|
|---|---|---|
|
The Pittsburgh Sleep Quality Index (PSQI) Total Score at Week 0 and Week 12
Week 0, n=22, 12
|
10.3 units on a scale
Standard Deviation 2.98
|
10.5 units on a scale
Standard Deviation 3.71
|
|
The Pittsburgh Sleep Quality Index (PSQI) Total Score at Week 0 and Week 12
Week 12, n=12, 5
|
7.3 units on a scale
Standard Deviation 2.90
|
8.6 units on a scale
Standard Deviation 2.51
|
SECONDARY outcome
Timeframe: DBT WD (up to Week 12)Population: FAS. Participants with missing DBT WD data were not included in this analysis.
The PSQI consists of the following 7 domains: sleep quality, duration getting to sleep, sleep duration, sleep adequacy, sleep disturbance, use of sleeping pill, and somnolence. These domains are numerically scored from 0 to 3, with 0 representing the least severe response and 3 representing the most severe response. The PSQI total score is calculated by summing the individual domain scores. The highest possible score is 21, which represents the most disturbances in sleep quality; the lowest possible score is 0, which represents an absence of disturbances in sleep quality.
Outcome measures
| Measure |
Ropinirole IR-Ropinirole IR
n=8 Participants
Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed Clinical Global Impression - Improvement \[CGI-I\]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
|
Placebo-Ropinirole IR
n=7 Participants
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
|
|---|---|---|
|
The PSQI Total Score for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)
|
7.8 units on a scale
Standard Deviation 3.54
|
7.3 units on a scale
Standard Deviation 3.15
|
SECONDARY outcome
Timeframe: LONG WD (up to Week 64)Population: FAS. Participants with no measurement data in the long-term treatment period because of their premature withdrawal without receiving the IP in that period were not included in the analysis.
The PSQI consists of the following 7 domains: sleep quality, duration getting to sleep, sleep duration, sleep adequacy, sleep disturbance, use of sleeping pill, and somnolence. These domains are numerically scored from 0 to 3, with 0 representing the least severe response and 3 representing the most severe response. The PSQI total score is calculated by summing the individual domain scores. The highest possible score is 21, which represents the most disturbances in sleep quality; the lowest possible score is 0, which represents an absence of disturbances in sleep quality.
Outcome measures
| Measure |
Ropinirole IR-Ropinirole IR
n=11 Participants
Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed Clinical Global Impression - Improvement \[CGI-I\]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
|
Placebo-Ropinirole IR
n=4 Participants
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
|
|---|---|---|
|
The PSQI Total Score for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)
|
8.8 units on a scale
Standard Deviation 3.57
|
9.3 units on a scale
Standard Deviation 3.10
|
SECONDARY outcome
Timeframe: Week 0 and Week 12Population: FAS. Participants withdrawn from the study before Week 12 were not included in the analysis.
Participants responded to a question about their satisfaction with the IP on the following 1 to 7 scale: 1 = very much satisfied; 2 = satisfied; 3 = somewhat satisfied; 4 = neither satisfied nor dissatisfied; 5 = somewhat dissatisfied; 6 = dissatisfied; and 7 = very dissatisfied. At Week 0, participants responded to a question about their satisfaction with their prior medications.
Outcome measures
| Measure |
Ropinirole IR-Ropinirole IR
n=22 Participants
Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed Clinical Global Impression - Improvement \[CGI-I\]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
|
Placebo-Ropinirole IR
n=12 Participants
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
|
|---|---|---|
|
Number of Participants With the Indicated Responses to the Patient Satisfaction Question at Week 0 and Week 12
Week 0, n=22,12; Very satisfied
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Responses to the Patient Satisfaction Question at Week 0 and Week 12
Week 0, n=22, 12; Satisfied
|
3 participants
|
6 participants
|
|
Number of Participants With the Indicated Responses to the Patient Satisfaction Question at Week 0 and Week 12
Week 0, n=22, 12; Somewhat satisfied
|
4 participants
|
2 participants
|
|
Number of Participants With the Indicated Responses to the Patient Satisfaction Question at Week 0 and Week 12
Week 0, n=22, 12; Neither satisfied/dissatisfied
|
10 participants
|
2 participants
|
|
Number of Participants With the Indicated Responses to the Patient Satisfaction Question at Week 0 and Week 12
Week 0, n=22, 12; Somewhat dissatisfied
|
1 participants
|
1 participants
|
|
Number of Participants With the Indicated Responses to the Patient Satisfaction Question at Week 0 and Week 12
Week 0, n=22, 12; Dissatisfied
|
3 participants
|
0 participants
|
|
Number of Participants With the Indicated Responses to the Patient Satisfaction Question at Week 0 and Week 12
Week 0, n=22, 12; Very dissatisfied
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Responses to the Patient Satisfaction Question at Week 0 and Week 12
Week 12, n=12, 5; Very satisfied
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Responses to the Patient Satisfaction Question at Week 0 and Week 12
Week 12, n=12, 5; Satisfied
|
4 participants
|
3 participants
|
|
Number of Participants With the Indicated Responses to the Patient Satisfaction Question at Week 0 and Week 12
Week 12, n=12, 5; Somewhat satisfied
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Responses to the Patient Satisfaction Question at Week 0 and Week 12
Week 12, n=12, 5; Neither satisfied/dissatisfied
|
3 participants
|
1 participants
|
|
Number of Participants With the Indicated Responses to the Patient Satisfaction Question at Week 0 and Week 12
Week 12, n=12, 5; Somewhat dissatisfied
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Responses to the Patient Satisfaction Question at Week 0 and Week 12
Week 12, n=12, 5; Dissatisfied
|
3 participants
|
0 participants
|
|
Number of Participants With the Indicated Responses to the Patient Satisfaction Question at Week 0 and Week 12
Week 12, n=12, 5, Very dissatisfied
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: LONG WD (up to Week 64)Population: FAS. Participants with no measurement data in the long-term treatment period because of their premature withdrawal without receiving the IP in that period were not included in the analysis.
Participants responded to a question about their satisfaction with the IP on the following 1 to 7 scale: 1 = very much satisfied; 2 = satisfied; 3 = somewhat satisfied; 4 = neither satisfied nor dissatisfied; 5 = somewhat dissatisfied; 6 = dissatisfied; and 7 = very dissatisfied. At Week 0, participants responded to a question about their satisfaction with their prior medications.
Outcome measures
| Measure |
Ropinirole IR-Ropinirole IR
n=11 Participants
Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed Clinical Global Impression - Improvement \[CGI-I\]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
|
Placebo-Ropinirole IR
n=4 Participants
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
|
|---|---|---|
|
Number of Participants With the Indicated Responses to the Patient Satisfaction Question for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)
Very satisfied
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Responses to the Patient Satisfaction Question for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)
Satisfied
|
2 participants
|
0 participants
|
|
Number of Participants With the Indicated Responses to the Patient Satisfaction Question for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)
Somewhat satisfied
|
3 participants
|
1 participants
|
|
Number of Participants With the Indicated Responses to the Patient Satisfaction Question for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)
Neither satisfied/dissatisfied
|
2 participants
|
1 participants
|
|
Number of Participants With the Indicated Responses to the Patient Satisfaction Question for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)
Somewhat dissatisfied
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Responses to the Patient Satisfaction Question for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)
Dissatisfied
|
2 participants
|
0 participants
|
|
Number of Participants With the Indicated Responses to the Patient Satisfaction Question for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)
Very dissatisfied
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: DBT WD (up to Week 12)Population: FAS. Participants with missing DBT WD data were not included in the analysis.
Participants responded to a question about their satisfaction with the IP on the following 1 to 7 scale: 1 = very much satisfied; 2 = satisfied; 3 = somewhat satisfied; 4 = neither satisfied nor dissatisfied; 5 = somewhat dissatisfied; 6 = dissatisfied; and 7 = very dissatisfied. At Week 0, participants responded to a question about their satisfaction with their prior medications.
Outcome measures
| Measure |
Ropinirole IR-Ropinirole IR
n=8 Participants
Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed Clinical Global Impression - Improvement \[CGI-I\]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
|
Placebo-Ropinirole IR
n=7 Participants
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
|
|---|---|---|
|
Number of Participants With the Indicated Responses to the Patient Satisfaction Question for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)
Dissatisfied
|
0 participants
|
0 participants
|
|
Number of Participants With the Indicated Responses to the Patient Satisfaction Question for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)
Very dissatisfied
|
1 participants
|
1 participants
|
|
Number of Participants With the Indicated Responses to the Patient Satisfaction Question for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)
Very satisfied
|
2 participants
|
2 participants
|
|
Number of Participants With the Indicated Responses to the Patient Satisfaction Question for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)
Satisfied
|
0 participants
|
1 participants
|
|
Number of Participants With the Indicated Responses to the Patient Satisfaction Question for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)
Somewhat satisfied
|
1 participants
|
0 participants
|
|
Number of Participants With the Indicated Responses to the Patient Satisfaction Question for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)
Neither satisfied/dissatisfied
|
3 participants
|
2 participants
|
|
Number of Participants With the Indicated Responses to the Patient Satisfaction Question for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)
Somewhat dissatisfied
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Week 0 and Week 12Population: FAS. Participants without symptoms were not included in the analysis of Week 0 data. Participants without symptoms and participants prematurely withdrawn from the study were not included in the analysis of Week 12 data.
Participants recorded the onset time and total duration of RLS symptoms on their diary cards for 7 days from one week before each visit. Timeframes were defined as follows: daytime, 7:00AM to 4:59PM; evening, 5:00PM to 7:59PM; and nighttime, 8:00PM to 6:59AM.
Outcome measures
| Measure |
Ropinirole IR-Ropinirole IR
n=21 Participants
Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed Clinical Global Impression - Improvement \[CGI-I\]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
|
Placebo-Ropinirole IR
n=12 Participants
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
|
|---|---|---|
|
Mean Daily Number of Hours of RLS Symptoms by Timeframe at Week 0 and Week 12
Evening, Week 0, n=11, 9
|
1.296 hours
Standard Deviation 0.7910
|
1.148 hours
Standard Deviation 0.8170
|
|
Mean Daily Number of Hours of RLS Symptoms by Timeframe at Week 0 and Week 12
Evening, Week 12, n=6, 2
|
1.097 hours
Standard Deviation 0.9323
|
0.783 hours
Standard Deviation 0.3064
|
|
Mean Daily Number of Hours of RLS Symptoms by Timeframe at Week 0 and Week 12
Nighttime, Week 0, n=21, 12
|
2.256 hours
Standard Deviation 1.5310
|
2.318 hours
Standard Deviation 2.3618
|
|
Mean Daily Number of Hours of RLS Symptoms by Timeframe at Week 0 and Week 12
Nighttime, Week 12, n=9, 4
|
1.726 hours
Standard Deviation 1.4537
|
1.688 hours
Standard Deviation 1.1607
|
|
Mean Daily Number of Hours of RLS Symptoms by Timeframe at Week 0 and Week 12
Daytime, Week 0, n=16, 9
|
1.794 hours
Standard Deviation 1.6875
|
1.857 hours
Standard Deviation 1.9437
|
|
Mean Daily Number of Hours of RLS Symptoms by Timeframe at Week 0 and Week 12
Daytime, Week 12, n=7, 3
|
1.482 hours
Standard Deviation 1.3927
|
0.735 hours
Standard Deviation 0.3841
|
SECONDARY outcome
Timeframe: DBT WD (up to Week 12)Population: FAS. Only participants with symptoms who were able to record them in the diary card were included in the analyses of the DBT WD data.
Participants recorded the onset time and total duration of RLS symptoms on their diary cards for 7 days from one week before each visit. Timeframes were defined as follows: daytime, 7:00AM to 4:59PM; evening, 5:00PM to 7:59PM; and nighttime, 8:00PM to 6:59AM.
Outcome measures
| Measure |
Ropinirole IR-Ropinirole IR
n=3 Participants
Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed Clinical Global Impression - Improvement \[CGI-I\]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
|
Placebo-Ropinirole IR
n=2 Participants
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
|
|---|---|---|
|
Mean Daily Number of Hours of RLS Symptoms by Timeframe for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)
Daytime, n=1, 2
|
9.590 hours
Standard Deviation NA
Only one participant was analyzed in this group at this time point.
|
2.900 hours
Standard Deviation 3.6770
|
|
Mean Daily Number of Hours of RLS Symptoms by Timeframe for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)
Evening, n=1, 1
|
2.590 hours
Standard Deviation NA
Only one participant was analyzed in this group at this time point.
|
2.590 hours
Standard Deviation NA
Only one participant was analyzed in this group at this time point.
|
|
Mean Daily Number of Hours of RLS Symptoms by Timeframe for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD)
Nighttime, n=3, 2
|
1.802 hours
Standard Deviation 2.7692
|
2.936 hours
Standard Deviation 3.1422
|
SECONDARY outcome
Timeframe: LONG WD (up to Week 64)Population: FAS. Only participants with symptoms who were able to record them in the diary card were included in the analyses of the and LONG WD data.
Participants recorded the onset time and total duration of RLS symptoms on their diary cards for 7 days from one week before each visit. Timeframes were defined as follows: daytime, 7:00AM to 4:59PM; evening, 5:00PM to 7:59PM; and nighttime, 8:00PM to 6:59AM.
Outcome measures
| Measure |
Ropinirole IR-Ropinirole IR
n=2 Participants
Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed Clinical Global Impression - Improvement \[CGI-I\]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
|
Placebo-Ropinirole IR
n=2 Participants
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
|
|---|---|---|
|
Mean Daily Number of Hours of RLS Symptoms by Timeframe for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)
Daytime, n=0, 2
|
NA hours
Standard Deviation NA
No participants were analyzed in this group at this time point.
|
0.883 hours
Standard Deviation 0.7778
|
|
Mean Daily Number of Hours of RLS Symptoms by Timeframe for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)
Evening, n=1, 2
|
0.200 hours
Standard Deviation NA
Only one participant was analyzed in this group at this time point.
|
1.948 hours
Standard Deviation 0.6399
|
|
Mean Daily Number of Hours of RLS Symptoms by Timeframe for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD)
Nighttime, n=2, 1
|
2.432 hours
Standard Deviation 2.9446
|
0.867 hours
Standard Deviation NA
Only one participant was analyzed in this group at this time point.
|
SECONDARY outcome
Timeframe: Week 12 through Week 64Population: PK analysis was not performed because there were no participants (who had received a maintenance dose of the IP for more than 1 week in the long-term treatment period) from whom a blood sample could be collected when decision of study termination was made.
For on-dialysis analysis, measurements were to have been taken 1 hour before dialysis, in the artery/vein at the beginning, during, and end of dialysis, and 1 hour after dialysis. For off-dialysis analysis, measurements were to have been taken 1 hour before dialysis, at the beginning, during, and end of dialysis, and 1 hour after dialysis.
Outcome measures
Outcome data not reported
Adverse Events
Ropinirole IR-Ropinirole IR
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo-Ropinirole IR
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ropinirole IR-Ropinirole IR
n=22 participants at risk
Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
|
Placebo-Ropinirole IR
n=12 participants at risk
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
|
|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
4.5%
1/22 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
0.00%
0/12 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/22 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
8.3%
1/12 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/22 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
8.3%
1/12 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
Other adverse events
| Measure |
Ropinirole IR-Ropinirole IR
n=22 participants at risk
Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting "much improved" or "very much improved" in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
|
Placebo-Ropinirole IR
n=12 participants at risk
Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
40.9%
9/22 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
50.0%
6/12 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
|
Infections and infestations
Gastroenteritis
|
9.1%
2/22 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
0.00%
0/12 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/22 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
8.3%
1/12 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/22 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
8.3%
1/12 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
|
Gastrointestinal disorders
Nausea
|
13.6%
3/22 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
8.3%
1/12 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
2/22 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
8.3%
1/12 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
9.1%
2/22 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
0.00%
0/12 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
2/22 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
0.00%
0/12 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/22 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
8.3%
1/12 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/22 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
8.3%
1/12 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/22 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
8.3%
1/12 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/22 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
8.3%
1/12 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/22 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
8.3%
1/12 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
|
Vascular disorders
Orthostatic hypotension
|
9.1%
2/22 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
8.3%
1/12 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
|
Vascular disorders
Hypertension
|
9.1%
2/22 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
0.00%
0/12 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
4.5%
1/22 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
8.3%
1/12 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
4.5%
1/22 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
8.3%
1/12 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/22 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
8.3%
1/12 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/22 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
8.3%
1/12 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/22 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
8.3%
1/12 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
|
Nervous system disorders
Headache
|
4.5%
1/22 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
0.00%
0/12 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/22 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
8.3%
1/12 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/22 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
8.3%
1/12 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/22 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
8.3%
1/12 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/22 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
8.3%
1/12 • Adverse events were to be collected from the start of the IP (Week 0) through Week 64 and during the 4-week follow-up period. The maximum observed duration of exposure to the IP was 168 days because of the early termination of the study.
|
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