Trial · NCT00365352
Outcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in IRLS Rating Scale Total Score at Week 12 Using Last Observation Carried Forward (LOCF) | Baseline and Week 12 | Modified Intent-to-Treat (MITT) Population: all participants in the Safety Population who also satisfied all of the following conditions: (1) completed the IRLS Rating Scale at Baseline; and (2) completed at least one on-treatment IRLS Rating Scale score during the treatment period | scores on a scale | MEAN |
| PRIMARY | Number of Participants With a Score of Much Improved or Very Much Improved on the Investigator-rated CGI-I Scale (Response) at (Week 12) Using LOCF | Week 12 | MITT Population | participants | NUMBER |
| SECONDARY | Change From Baseline to the End of Treatment (Week 12) in the IRLS Rating Scale Total Score Using LOCF | Baseline (Day 1) and End of Treatment (Week 12) | MITT Population. The number of participants assessed varies due to incomplete/missing data. | scores on a scale | MEAN |
| SECONDARY | Number of Participants Classsified as Responders on the Investigator-rated CGI-I Scale at Week 12 Using LOCF | Week 12 | MITT Population. The number of participants assessed varies due to incomplete/missing data. | participants | NUMBER |
| SECONDARY | Number of Participants Who Had an Onset of Response to Treatment at the End of Week 1 Based Upon the IRLS Rating Scale Total Score and the Investigator-rated CGI-I Using LOCF | End of Week 1 | MITT Population. The number of participants assessed varies due to incomplete/missing data. | participants | NUMBER |
| SECONDARY | The Time to Onset of the First Response to Treatment on the IRLS Rating Scale Total Score and the Investigator-rated CGI-I | Baseline (Day 1) to End of Treatment (Week 12) | MITT Population. The number of participants assessed varies due to incomplete/missing data. | weeks | MEDIAN |
| SECONDARY | Mean Change in the IRLS Rating Scale Total Score From Baseline at Week 12 by RLS Treatment History Using LOCF | Baseline (Day 1) and Week 12 | MITT Population. The number of participants assessed varies due to incomplete/missing data. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in the IRLS Rating Scale Total Score at Week 12 by Baseline RLS Rating Scale Total Score Category (Baseline RLS Severity) Using LOCF | Baseline (Day 1) and Week 12 | MITT Population. The number of participants assessed varies due to incomplete/missing data. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline to the End of Week 1 in the IRLS Rating Scale Total Score Using LOCF | Baseline and the End of Week 1 | MITT Population. The number of participants assessed varies due to incomplete/missing data. | scores on a scale | MEAN |
| SECONDARY | Number of Participants Classified as Investigator-rated CGI-I Scale Responders at Week 12 by RLS Treatment History Using LOCF | Basline and Week 12 | Participants included in the MITT Population with a known RLS treatment history | participants | NUMBER |
| SECONDARY | Number of Total Responders to Treatment Based on the Investigator-Rated CGI of Improvement at the End of One Week of Treatment | End of Week 1 | MITT Population. The number of participants assessed varies due to incomplete/missing data. | responders | NUMBER |
| SECONDARY | Change From Baseline to the End of Treatment in Average Daily Total Sleep Time (Hours) Using LOCF | Baseline to End of Treatment (Week 12) | MITT Population. The number of participants assessed varies due to incomplete/missing data. | hours | MEAN |
| SECONDARY | Change From Baseline to the End of Treatment in Average Daily Wake Time (Minutes) After Sleep Onset Using LOCF | Baseline to End of Treatment (Week 12) | MITT Popultion. The number of participants assessed varies due to incomplete/missing data. | minutes | MEAN |
| SECONDARY | Change From Baseline in the Average Daily RLS Pain Score at the End of Treatment (Week 12) for Participants With Pain at Baseline or the End of Week 12 Using LOCF | Baseline and End of Treatment (Week 12) | MITT Population. The number of participants assessed varies due to incomplete/missing data. | scores on a scale | MEAN |
| SECONDARY | Number of Participants Classified as Responders With at Least 30% and 50% Improvement in the Average Daily RLS Pain Score Using LOCF | Week 12 | MITT Population. The number of participants assessed varies due to incomplete/missing data. | participants | NUMBER |
| SECONDARY | Change From Baseline in the Average Daily RLS Pain Score to Week 12 for Participants With a Baseline Pain Score of at Least 4 Using LOCF | Baseline and Week 12 | MITT Population. The number of participants assessed varies due to incomplete/missing data. | scores on a scale | MEAN |
| SECONDARY | Number of Participants Classified as Responders to Treatment Based on the Participant-Rated CGI of Improvement at Week 1 and Week 12 (End of Treatment) | Week 1 and Week 12 | MITT Population. The number of participants assessed varies due to incomplete/missing data. | participants | NUMBER |
| SECONDARY | Number of Participants With a Rating of Excellent for the Overall Quality of Sleep in Past Week Measured by the Post-Sleep Questionnaire (PSQ) at the End of Treatment (Week 12) Using LOCF | End of Treatment (Week 12) | MITT Population. The number of participants assessed varies due to incomplete/missing data. | participants | NUMBER |
| SECONDARY | Number of Participants Who Indicated on the Mood Assessment That Their Mood Was Much Improved or Very Much Improved at Week 12 (End of Treatment) Using LOCF | Week 12 | MITT Population. The number of participants assessed varies due to incomplete/missing data. | participants | NUMBER |
| SECONDARY | Change From Baseline in the Profile of Mood State (POMS) Scale at Week 12 Using LOCF | Baseline to End of Treatment (Week 12) | MITT Population. The number of participants assessed varies due to incomplete/missing data. | scores on a scale | 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/NCT00365352/outcomes