Trial · NCT00654498
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Change From Baseline to Week 6 in the Total Score of Restless Legs Syndrome Rating Scale for Severity of the International Restless Legs Syndrome Study Group (IRLS). | Baseline and 6 weeks of treatment | The IRLS was a 10-item self patient's rating scale for assessing severity of restless legs syndrome symptoms with each item ranging from 0 (no symptoms) to 4 (very severe symptoms). The total IRLS score ranges from 0 (no symptoms) to 40 (worst possible symptoms). |
| Primary | The Proportion of Patients With Clinical Global Impressions -Improvement Scale (CGI-I) Assessment of "Much Improved" and "Very Much Improved" | 6 weeks of treatment | CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved)and 2 (much improved. |
| Secondary | The Proportion of IRLS Responders | 6 weeks of treatment | responders is defined as the total score in IRLS changed ≥ 50%from baseline calculated in the full analysis set population. |
| Secondary | The Proportion of Patient Global Impression(PGI) Responders | 6 weeks of treatment | PGI was a one-question scale with 7 degrees to assess patient's overall condition, ranging from very much better to very much worse. The responder are defined as patients with their assessment of "much better" or "very much better". |
| Secondary | The Proportion of Patients With Epworth Sleepiness Scale (ESS) Categorised >10 | week 6 of treatment | The ESS is a self-administered instrument to assess the patients likelihood of falling asleep in various activities of daily living; the maximum score is 24 indicating a very high level of daytime sleepiness and a high likelihood of falling asleep. |
| Secondary | the Mean Change From Baseline to Week 6 in Satisfaction of Sleep at Night of RLS-6 Rating Scales | Baseline and 6 weeks of treatment | RLS-6 rating scales comprises 6 questions Satisfaction of sleep is one of the 6 questions. The patient should give a rate between 0 (none/Not at all) to 10 (very severe) for the satisfaction of sleep. |
| Secondary | The Mean Change From Baseline in the Severity of RLS at Time of Falling Sleep of RLS-6 Rating Scales. | Baseline and 6 weeks of treatment | RLS-6 rating scales comprises 6 questions. The severity of RLS at time of falling sleep is one of the 6 questions. The patient should give a rate between 0 (none/Not at all) to 10 (very severe) for the severity of RLS at time of falling sleep |
| Secondary | The Mean Change From Baseline in the Severity of RLS During the Night of RLS-6 Rating Scales. | Baseline and 6 weeks of treatment | RLS-6 rating scales comprises 6 questions. The severity of RLS during the night is one of the 6 questions. The patient should give a rate between 0 ("none/Not at all") to 10 ("very severe") for the severity of RLS during the night. |
| Secondary | The Mean Change From Baseline in the Severity of RLS During the Rest at Day of RLS-6 Rating Scales. | Baseline and 6 weeks of treatment | RLS-6 rating scales comprises 6 questions. The severity of RLS during the test at day is one of the 6 questions. The patient should give a rate between 0 ("none/Not at all") to 10 ("very severe") for the severity of RLS during the rest at day. |
| Secondary | The Mean Change From Baseline in the Severity of RLS During the Activities at Day of RLS-6 Rating Scale | Baseline and 6 weeks of treatment | RLS-6 rating scales comprises 6 questions. The severity of RLS during the activities at day is one of the 6 questions. The patient should give a rate between 0 ("none/Not at all") to 10 ("very severe") for the severity of RLS during the activity at day. |
| Secondary | The Mean Change From Baseline in the Intensity of Tiredness and Sleepiness at Day of RLS-6 Rating Scale | Baseline and 6 weeks of treatment | RLS-6 rating scales comprises 6 questions. The intensity of tiredness and sleepiness at day is one of the 6 questions. The patient should give a rate between 0 ("none/Not at all") to 10 ("very severe") for the intensity of tiredness and sleepiness at day. |
| Secondary | The Change From Baseline in Visual Analogue Scales (VAS) | Baseline and 6 weeks of treatment | VAS is for assessment of RLS-associated pain. The patient was asked "How severe was your RLS associated pain in legs or arms during the past week?". No pain:0; very worst pain:10 |
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/NCT00654498/registered