Trial · NCT01084551
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | International Restless Legs Syndrome Rating Scale (IRLS) Total Score | Baseline, the end of dose-titration/dose-maintenance period (week 13) | Change from the baseline to the end of dose-titration/dose-maintenance period. IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually 'very severe') to 0 for the last answer (usually none). The sum of the score of each question serves as the scale score. The scale scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40). A decrease in the scores means improvement. |
| Secondary | Clinical Global Impression (CGI) Improvement | Baseline, the end of dose-titration/dose-maintenance period (week 13) | CGI improvement is a clinician-reported scale for assessing how much the patient's illness has improved or worsened from baseline. The scale scoring criteria are 1: very much improved, 2: much improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: much worse, 7: very much worse. |
| Secondary | Patient Global Impression (PGI) Improvement | Baseline, the end of dose-titration/dose-maintenance period (week 13) | PGI improvement is a patient-reported scale for assessing how much the patient's illness has improved or worsened from baseline. The scale scoring criteria are 1: very much better, 2: much better, 3: a little better, 4: no change, 5: a little worse, 6: much worse, 7: very much worse. |
| Secondary | The Pittsburgh Sleep Quality Index (PSQI) | Baseline, the end of dose-titration/dose-maintenance period (week 13) | Change of PSQI from baseline to the end of dose-titration/dose-maintenance period. PSQI is a scale for assessing severity of sleep disorders. The score ranges from 0 to 21. 0 indicates "no difficulty" and 21 indicates "severe difficulty". A decrease in the scores means improvement. |
| Secondary | Each Item of IRLS (10 Items) | Baseline, the end of dose-titration/dose-maintenance period (week 13) | IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually 'very severe') to 0 for the last answer (usually none). Numbers of subjects with -4 or -3 score change from baseline in each item of IRLS. A decrease in the scores means improvement. |
| Secondary | Incidence of RLS Symptoms | Baseline, the end of dose-titration/dose-maintenance period (week 13) | Incidence rate of RLS symptoms is calculated as the number of days with RLS symptoms in the week / the number of evaluation days in the week\* 100% |
| Secondary | Average Duration of RLS Symptoms | Baseline, the end of dose-titration/dose-maintenance period (weeks 13) | Change of average duration of RLS symptoms in a week from baseline to the end of dose-titration/dose-maintenance period. Only the days with RLS symptoms are used for calculation. |
| Secondary | Incidence of RLS Symptoms in the Evening and Night | Baseline, the end of dose-titration/dose-maintenance period (week 13) | Incidence rate of RLS symptoms is calculated as the number of days with RLS symptoms / the number of days of evaluation \* 100%. |
| Secondary | Average Duration of RLS Symptoms in the Evening and Night in a Week | Baseline, the end of dose-titration/dose-maintenance period (weeks 13) | Change of average duration of RLS symptoms in a week from baseline to the end of dose-titration/dose-maintenance period. Only the days with RLS symptoms are used for calculation. |
| Secondary | Nocturnal Awakenings Due to RLS Symptoms in a Week | Baseline, the end of dose-titration/dose-maintenance period (week 13) | Nocturnal awakening rate is calculated as the number of days with nocturnal awakenings / the number of days of evaluation \* 100%. |
| Secondary | Average Sleep Time in a Week | Baseline, the end of dose-titration/dose-maintenance period (weeks 13) | Change of average sleep time in a week from baseline to the end of dose-titration/dose-maintenance period. |
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/NCT01084551/registered