Trial · NCT00996944
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)
NCT00996944, Phase 2, Terminated, GlaxoSmithKline; results first posted 2011-06-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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). Trials, record NCT00996944. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00996944
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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 number
- NCT00996944
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 34 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Restless Legs Syndrome
- Interventions
- Ropinirole immediate release (IR), Placebo
- First posted
- 2009-10-16
- Last updated
- 2018-08-10
- Results first posted
- 2011-06-13
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | International Restless Legs Syndrome (IRLS) Rating Scale Total Score at Week 0 and Week 12 | Week 0 and Week 12 | 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 A total of 17 participants were prematurely withdrawn from the study before Week 12. |
| Primary | IRLS Rating Scale Total Score for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD) | DBT WD (up to Week 12) | 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. |
| Secondary | IRLS Rating Scale Total Score for Participants Who Withdrew in the Long-term Treatment Period (LONG WD) | LONG WD (up to Week 64) | 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. |
| Secondary | Number of Participants With the Indicated Clinical Global Impression-Improvement (CGI-I) Scores at Week 12 | Week 12 | 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. |
| Secondary | Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD) | DBT WD (up to Week 12) | 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. |
| Secondary | Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD) | LONG WD (up to Week 64) | 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. |
| Secondary | Johns Hopkins Restless Legs Syndrome Quality of Life (RLSQOL) Questionnaire Overall Life Impact Score at Week 0 and Week 12 | Week 0 and Week 12 | 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. |
| Secondary | Johns Hopkins RLSQOL Questionnaire Overall Life Impact Score for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD) | DBT WD (up to Week 12) | 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. |
| Secondary | Johns Hopkins RLSQOL Questionnaire Overall Life Impact Score for Participants Who Withdrew in the Long-term Treatment Period (LONG WD) | LONG WD (up to Week 64) | 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. |
| Secondary | The Pittsburgh Sleep Quality Index (PSQI) Total Score at Week 0 and Week 12 | Week 0 and Week 12 | 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. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | International Restless Legs Syndrome (IRLS) Rating Scale Total Score at Week 0 and Week 12 | Week 0 and Week 12 | 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. | units on a scale | MEAN |
| SECONDARY | IRLS Rating Scale Total Score for Participants Who Withdrew in the Long-term Treatment Period (LONG WD) | LONG WD (up to Week 64) | 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. | units on a scale | MEAN |
| SECONDARY | Number of Participants With the Indicated Clinical Global Impression-Improvement (CGI-I) Scores at Week 12 | Week 12 | FAS. Participants withdrawn from the study before Week 12 were not included in the analysis. | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD) | DBT WD (up to Week 12) | FAS. Participants with missing DBT WD data were not included in the analysis. | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated CGI-I Scores for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD) | LONG WD (up to Week 64) | 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 | NUMBER |
| SECONDARY | Johns Hopkins Restless Legs Syndrome Quality of Life (RLSQOL) Questionnaire Overall Life Impact Score at Week 0 and Week 12 | Week 0 and Week 12 | FAS. Participants withdrawn from the study before Week 12 were not included in the analysis. | units on a scale | MEAN |
| PRIMARY | IRLS Rating Scale Total Score for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD) | DBT WD (up to Week 12) | 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. | units on a scale | MEAN |
| SECONDARY | Johns Hopkins RLSQOL Questionnaire Overall Life Impact Score for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD) | DBT WD (up to Week 12) | FAS. Participants with missing DBT WD data were not included in the analysis. | units on a scale | MEAN |
| SECONDARY | Johns Hopkins RLSQOL Questionnaire Overall Life Impact Score for Participants Who Withdrew in the Long-term Treatment Period (LONG WD) | LONG WD (up to Week 64) | 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. | units on a scale | MEAN |
| SECONDARY | The Pittsburgh Sleep Quality Index (PSQI) Total Score at Week 0 and Week 12 | Week 0 and Week 12 | FAS. Participants withdrawn from the study before Week 12 were not included in the analysis. | units on a scale | MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group152
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| International Restless Legs Syndrome (IRLS) Rating Scale Total Score at Week 0 and Week 12 | Ropinirole IR-Ropinirole IR | Week 0, n=22, 12 | 26.0 | Standard Deviation 5.51 | units on a scale |
| International Restless Legs Syndrome (IRLS) Rating Scale Total Score at Week 0 and Week 12 | Placebo-Ropinirole IR | Week 0, n=22, 12 | 24.0 | Standard Deviation 3.64 | units on a scale |
| International Restless Legs Syndrome (IRLS) Rating Scale Total Score at Week 0 and Week 12 | Ropinirole IR-Ropinirole IR | Week 12, n=12, 5 | 15.9 | Standard Deviation 9.97 | units on a scale |
| International Restless Legs Syndrome (IRLS) Rating Scale Total Score at Week 0 and Week 12 | Placebo-Ropinirole IR | Week 12, n=12, 5 | 9.2 | Standard Deviation 5.26 | units on a scale |
| IRLS Rating Scale Total Score for Participants Who Withdrew in the Long-term Treatment Period (LONG WD) | Ropinirole IR-Ropinirole IR | 18.0 | Standard Deviation 12.26 | units on a scale | |
| IRLS Rating Scale Total Score for Participants Who Withdrew in the Long-term Treatment Period (LONG WD) | Placebo-Ropinirole IR | 16.5 | Standard Deviation 4.12 | units on a scale | |
| Number of Participants With the Indicated Clinical Global Impression-Improvement (CGI-I) Scores at Week 12 | Ropinirole IR-Ropinirole IR | Not Assessed | 0 | participants | |
| Number of Participants With the Indicated Clinical Global Impression-Improvement (CGI-I) Scores at Week 12 | Placebo-Ropinirole IR | Not Assessed | 0 | participants | |
| Number of Participants With the Indicated Clinical Global Impression-Improvement (CGI-I) Scores at Week 12 | Ropinirole IR-Ropinirole IR | Very Much Improved | 2 | participants | |
| Number of Participants With the Indicated Clinical Global Impression-Improvement (CGI-I) Scores at Week 12 | Placebo-Ropinirole IR | Very Much Improved | 3 | participants |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Treatment Period | STARTED | Ropinirole IR-Ropinirole IR | 22 | |
| Double-blind Treatment Period | STARTED | Placebo-Ropinirole IR | 12 | |
| Double-blind Treatment Period | COMPLETED | Ropinirole IR-Ropinirole IR | 12 | |
| Double-blind Treatment Period | COMPLETED | Placebo-Ropinirole IR | 5 | |
| Double-blind Treatment Period | NOT COMPLETED | Ropinirole IR-Ropinirole IR | 10 | |
| Double-blind Treatment Period | NOT COMPLETED | Placebo-Ropinirole IR | 7 | |
| Long-term Treatment Period | STARTED | Ropinirole IR-Ropinirole IR | 12 | |
| Long-term Treatment Period | STARTED | Placebo-Ropinirole IR | 5 | |
| Long-term Treatment Period | COMPLETED | Ropinirole IR-Ropinirole IR | 0 | |
| Long-term Treatment Period | COMPLETED | Placebo-Ropinirole IR | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events56
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Ropinirole IR-Ropinirole IR | 9 | 22 | |
| other | Nasopharyngitis | Infections and infestations | Placebo-Ropinirole IR | 6 | 12 | |
| other | Gastroenteritis | Infections and infestations | Ropinirole IR-Ropinirole IR | 2 | 22 | |
| other | Gastroenteritis | Infections and infestations | Placebo-Ropinirole IR | 0 | 12 | |
| other | Hordeolum | Infections and infestations | Ropinirole IR-Ropinirole IR | 0 | 22 | |
| other | Hordeolum | Infections and infestations | Placebo-Ropinirole IR | 1 | 12 | |
| other | Upper respiratory tract infection | Infections and infestations | Ropinirole IR-Ropinirole IR | 0 | 22 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo-Ropinirole IR | 1 | 12 | |
| other | Nausea | Gastrointestinal disorders | Ropinirole IR-Ropinirole IR | 3 | 22 | |
| other | Nausea | Gastrointestinal disorders | Placebo-Ropinirole IR | 1 | 12 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ropinirole IR-Ropinirole IR | ||
| Total, all-cause mortality | Placebo-Ropinirole IR | ||
| Total, other adverse events | Ropinirole IR-Ropinirole IR | 16 | 22 |
| Total, other adverse events | Placebo-Ropinirole IR | 10 | 12 |
| Total, serious adverse events | Ropinirole IR-Ropinirole IR | 1 | 22 |
| Total, serious adverse events | Placebo-Ropinirole IR | 1 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ropinirole IR-Ropinirole IR vs Placebo-Ropinirole IR: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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