Trial · NCT00996944
Outcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| 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 These two participants were withdrawn from the study without receiving the IP in the long-term treatment period.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 Participants withdrawn from the study before Week 12 were not included in the analysis.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 Participants withdrawn from the study before Week 12 were not included in the analysis.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 |
| SECONDARY | The PSQI Total 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 this analysis. | units on a scale | MEAN |
| SECONDARY | The PSQI Total Score 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. | units on a scale | MEAN |
| SECONDARY | Number of Participants With the Indicated Responses to the Patient Satisfaction Question 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. | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Responses to the Patient Satisfaction Question 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 | Number of Participants With the Indicated Responses to the Patient Satisfaction Question 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 | Mean Daily Number of Hours of RLS Symptoms by Timeframe at Week 0 and Week 12 | Week 0 and Week 12 | 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. | hours | MEAN |
| SECONDARY | Mean Daily Number of Hours of RLS Symptoms by Timeframe for Participants Who Withdrew From the Double-Blind Treatment Period (DBT WD) | DBT WD (up to Week 12) | 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. | hours | MEAN |
| SECONDARY | Mean Daily Number of Hours of RLS Symptoms by Timeframe for Participants Who Withdrew fn the Long-term Treatment Period (LONG WD) | LONG WD (up to Week 64) | 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. | hours | MEAN |
| SECONDARY | Drug Clearance Rate On-Dialysis and Off-Dialysis During the Maintenance Dose Treatment Phase (in the Long-term Treatment Period) | Week 12 through Week 64 | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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