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Trial · NCT00654498

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYThe 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 treatmentFull Analysis Set (FAS), All patients randomized, treated, having data for primary endpointScore on a scaleLEAST_SQUARES_MEAN
PRIMARYThe Proportion of Patients With Clinical Global Impressions -Improvement Scale (CGI-I) Assessment of Much Improved and Very Much Improved6 weeks of treatmentProportion of PatientsNUMBER
SECONDARYThe Proportion of IRLS Responders6 weeks of treatmentProportion of PatientsNUMBER
SECONDARYThe Proportion of Patient Global Impression(PGI) Responders6 weeks of treatmentProportion of participantsNUMBER
SECONDARYThe Proportion of Patients With Epworth Sleepiness Scale (ESS) Categorised >10week 6 of treatmentProportion of PatientsNUMBER
SECONDARYthe Mean Change From Baseline to Week 6 in Satisfaction of Sleep at Night of RLS-6 Rating ScalesBaseline and 6 weeks of treatmentScore on a scaleMEAN
SECONDARYThe Mean Change From Baseline in the Severity of RLS at Time of Falling Sleep of RLS-6 Rating Scales.Baseline and 6 weeks of treatmentScore on a scaleMEAN
SECONDARYThe Mean Change From Baseline in the Severity of RLS During the Night of RLS-6 Rating Scales.Baseline and 6 weeks of treatmentScore on a scaleMEAN
SECONDARYThe Mean Change From Baseline in the Severity of RLS During the Rest at Day of RLS-6 Rating Scales.Baseline and 6 weeks of treatmentScore on a scaleMEAN
SECONDARYThe Mean Change From Baseline in the Severity of RLS During the Activities at Day of RLS-6 Rating ScaleBaseline and 6 weeks of treatmentScore on a scaleMEAN
SECONDARYThe Mean Change From Baseline in the Intensity of Tiredness and Sleepiness at Day of RLS-6 Rating ScaleBaseline and 6 weeks of treatmentScore on a scaleMEAN
SECONDARYThe Change From Baseline in Visual Analogue Scales (VAS)Baseline and 6 weeks of treatmentScore on a scaleMEAN

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.

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