Trial · NCT00676403
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Restless Leg Syndrome (RLS) International Restless Leg Group Symptom Severity Rating Scale (IRLS) Total Score at Week 6 | Baseline, Week 6 | ITT. Baseline statistics were calculated only for subjects who had a non-missing change from baseline at at least one post-baseline visit. Recall period = week prior to assessment. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Subjects Responding to Treatment as Assessed by the Clinical Global Impression - Improvement Scale (CGI-I) | Week 6 | ITT; N=number of subjects in a treatment group; n=number of subjects with a clinical Global Impressions Improvement (CGI-I) rating. | participants | NUMBER |
| SECONDARY | Number of Subjects With Categorical Scores on the Clinical Global Impression - Severity Scale (CGI-S) | Baseline, Week 1, Week 2, Week 4, Week 6, Last Observation Carried Forward (LOCF) | ITT; N=number of subjects in a treatment group. LOCF: Last Observation Carried Forward. | participants | NUMBER |
| SECONDARY | Subjective Sleep Questionnaire (SSQ): Latency Subscale; Observed Change From Baseline | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 | ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Subjective Sleep Questionnaire: Hours of Sleep Subscale; Observed Change From Baseline | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 | ITT; baseline statistics were calculated only for subjects who had a non-missing change from baseline at at least one post-baseline visit. | hours | LEAST_SQUARES_MEAN |
| SECONDARY | Subjective Sleep Questionnaire: Number of Awakenings Subscale; Observed Change From Baseline | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 | ITT; baseline statistics were calculated only for subjects who had a non-missing change from baseline in at least one post-baseline visit. | awakenings | LEAST_SQUARES_MEAN |
| SECONDARY | Subjective Sleep Questionnaire: Total Wake Time After Sleep Onset Subscale; Observed Change From Baseline | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 | ITT; baseline statistics were calculated only for subjects who had a non-missing change from baseline at at least one post-baseline visit. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Subjective Sleep Questionnaire: Quality of Sleep Subscale; Observed Change From Baseline | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 | ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Disturbance Subscale; Observed Change From Baseline | Baseline, Week 1, Week 2, Week 4, Week 6 | ITT, Baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Medical Outcomes Study - Sleep Scale (MOSS-SS): Snoring Subscale; Observed Change From Baseline | Baseline, Week 1, Week 2, Week 4, Week 6 | ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Medical Outcomes Study - Sleep Scale (MOSS-SS): Awaken Short of Breath or With Headache Subscale; Observed Change From Baseline | Baseline, Week 1, Week 2, Week 4, Week 6 | ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Adequacy Subscale; Observed Change From Baseline | Baseline, Week 1, Week 2, Week 4, Week 6 | ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Medical Outcomes Study - Sleep Scale (MOSS-SS): Somnolence Subscale; Observed Change From Baseline | Baseline,, Week 1, Week 2, Week 4, Week 6 | ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Medical Outcomes Study - Sleep Scale (MOSS-SS): Sleep Quantity Subscale; Observed Change From Baseline | Baseline,, Week 1, Week 2, Week 4, Week 6 | ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Medical Outcomes Study - Sleep Scale (MOSS-SS): 6-Item Sleep Problems Index; Observed Change From Baseline | Baseline, Week 1, Week 2, Week 4, Week 6 | ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Medical Outcomes Study - Sleep Scale (MOSS-SS): 9-Item Sleep Problems Index; Observed Change From Baseline | Baseline, Week 1, Week 2, Week 4, Week 6 | ITT; baseline statistics were calculated only for subjects who had non-missing change from baseline at at least one post-baseline visit. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Medical Outcomes Study - Sleep Scale (MOSS-SS): Optimal Sleep; Observed Cases Summarized by Week | Week 1, Week 2, Week 4, Week 6 | ITT | participants | NUMBER |
| SECONDARY | Restless Leg Syndrome - Quality of Life Scale (RLS-QoL): Change From Baseline to Week 6 | Baseline, Week 6 | ITT; N = Subjects who were randomized and received at least one dose of study drug; baseline n = subjects who were randomized and received at least one dose of study drug, and had baseline and post-baseline values. | scores on scales | LEAST_SQUARES_MEAN |
| SECONDARY | Medical Outcomes Study Short Form 36 (SF-36): Change From Baseline to Week 6 | Baseline, Week 6 | ITT; N = Subjects who were randomized and received at least one dose of study drug; baseline n = subjects who were randomized and received at least one dose of study drug, had baseline and post-baseline values. | scores on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Medical Outcomes Study Short Form 36 (SF-36); Number of Subjects With Self-Evaluated Change in Health Status Scores | Baseline, Week 6 | ITT; N = number of subjects in a treatment group. | participants | NUMBER |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00676403/outcomes