Trial · NCT01569464
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline To The End Of The Maintenance Period in International Restless Legs Scale (IRLS) Sum Score | Baseline to End of Maintenance Period (approximately 7 weeks) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables. | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change In Average Of Means Of Multiple Suggested Immobilization Test Discomfort Scale (m-SIT-DS) Values Of Each Individual Suggested Immobilization Test (SIT) For The Combination Of Multiple Suggested Immobilization Test (m SIT) | Baseline to End of Maintenance Period (approximately 7 weeks) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change In Average Of Means Of Periodic Limb Movement During Wakefulness Index (PLMWI) Change In Average Of Means Of Periodic Limb Movement During Wakefulness Index (PLMWI) For The Combination Of Multiple Suggested Immobilization Test (m-SIT) | Baseline to End of Maintenance Period (approximately 7 weeks) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 149 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change In Item Score From Baseline To The End Of The Maintenance Period In Satisfaction With Sleep (Item 1 of Restless Legs Syndrome 6 Rating Scales [RLS-6]) | Baseline to End of Maintenance Period (approximately 7 weeks) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change In Item Score From Baseline To The End Of The Maintenance Period In Severity Of Restless Legs Syndrome (RLS) At Bedtime (Item 2 of Restless Legs Syndrome 6 Rating Scales [RLS-6]) | Baseline to End of Maintenance Period (approximately 7 weeks) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change In Item Score From Baseline To The End Of The Maintenance Period In Severity Of Restless Legs Syndrome (RLS) During The Night (Item 3 of Restless Legs Syndrome 6 Rating Scales [RLS-6]) | Baseline to End of Maintenance Period (approximately 7 weeks) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change In Item Score From Baseline To The End Of The Maintenance Period In Severity Of Restless Legs Syndrome (RLS) At Daytime At Rest (Item 4 of Restless Legs Syndrome 6 Rating Scales [RLS-6]) | Baseline to End of Maintenance Period (approximately 7 weeks) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change In Item Score From Baseline To The End Of The Maintenance Period In Severity of Restless Legs Syndrome (RLS) At Daytime In Activity (Item 5 of Restless Legs Syndrome 6 Rating Scales [RLS-6]) | Baseline to End of Maintenance Period (approximately 7 weeks) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change In Item Score From Baseline To The End Of The Maintenance Period In Daytime Tiredness (Item 6 of Restless Legs Syndrome 6 Rating Scales [RLS-6]) | Baseline to End of Maintenance Period (approximately 7 weeks) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline To The End Of Maintenance Period In Daytime Somnolence Domain Score Of The Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R) | Baseline to End of Maintenance Period (approximately 7 weeks) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline To The End of Maintenance Period In Sleep Disturbance Domain Score Of The Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R) | Baseline to End of Maintenance Period (approximately 7 weeks) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline To The End of Maintenance Period In Sleep Adequacy Domain Score Of The Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R) | Baseline to End of Maintenance Period (approximately 7 weeks) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline To The End of Maintenance Period In Sleep Quantity Domain Score Of The Medical Outcomes Study (MOS) Sleep Scale - Revised (Sleep Scale-R) | Baseline to End of Maintenance Period (approximately 7 weeks) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change In Total Score From Baseline To The End of Maintenance Period On Profile Of Mood States Questionnaire (POMS) | Baseline to End of Maintenance Period (approximately 7 weeks) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in SF-36 Mental Component Summary Score | Baseline to End of Maintenance Period (approximately 7 weeks) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in SF-36 Physical Component Summary Score | Baseline to End of Maintenance Period (7 weeks) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables. | units on a scale | LEAST_SQUARES_MEAN |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT01569464/outcomes