Trial · NCT00806026
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Restless Legs Syndrome (RLS) Symptom Severity | Baseline | Intent-to-treat (ITT) population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively. | Units on a Scale | MEAN |
| PRIMARY | Change From Baseline in the RLS Symptom Severity at Week 12 | Baseline, Week 12 | ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively. | Units on a Scale | LEAST_SQUARES_MEAN |
| PRIMARY | Percentage of Participants Responding to Treatment at Week 12 | Week 12 | ITT population. Last observation carried forward (LOCF) method was used. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Augmentation | Baseline up to Week 52 | ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively. | Percentage of participants | NUMBER |
| SECONDARY | Subjective Sleep Questionnaire (SSQ): Subjective Waking After Sleep Onset (WASO) | Baseline | ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively. | minutes | MEAN |
| SECONDARY | Change From Baseline in SSQ: Subjective WASO at Week 12 | Baseline, Week 12 | ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Subjective Sleep Questionnaire (SSQ): Latency Subscale Score at Week 12 | Week 12 | ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively. | minutes | MEAN |
| SECONDARY | Subjective Sleep Questionnaire (SSQ): Hours of Sleep Subscale Score at Week 12 | Week 12 | ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively. | hours | MEAN |
| SECONDARY | Subjective Sleep Questionnaire (SSQ): Number of Awakenings Subscale Score at Week 12 | Week 12 | ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively. | awakenings | MEAN |
| SECONDARY | Subjective Sleep Questionnaire (SSQ): Quality of Sleep Subscale Score at Week 12 | Week 12 | ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively. | Units on a scale | MEAN |
| SECONDARY | RLS-Next Day Impact (RLS-NDI) | Baseline | ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively. | Units on a Scale | MEAN |
| SECONDARY | Change From Baseline in RLS-NDI at Week 12 | Baseline, Week 12 | ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively. | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Limb Pain-Visual Analog Scale (Limb Pain-VAS) | Baseline | ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively. | mm | MEAN |
| SECONDARY | Change From Baseline in Limb Pain-VAS at Week 12 | Baseline, Week 12 | ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively. | mm | LEAST_SQUARES_MEAN |
| SECONDARY | Severity of Augmentation Symptoms at Week 12 | Week 12 | ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively. | Units on a Scale | MEAN |
| SECONDARY | Clinical Global Impressions-Severity (CGI-S) at Week 12 | Week 12 | ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively. | Units on a Scale | MEAN |
| SECONDARY | Medical Outcomes Study-Sleep Scale (MOS-SS) at Week 12 | Week 12 | ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, 'n' is signifying those participants who were evaluable for particular category for each group respectively. | Units on a Scale | MEAN |
| SECONDARY | Number of Participants With Medical Outcomes Study-Sleep Scale (MOS-SS)- Optimal Sleep at Week 12 | Week 12 | ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively. | Participants | NUMBER |
| SECONDARY | Profile of Mood State (POMS) at Week 12 | Week 12 | Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis due to lack of sufficient knowledge as how to analyze mood data inferentially in RLS population. | ||
| SECONDARY | Restless Legs Syndrome-Quality of Life Scale (RLS-QoL) at Week 12 | Week 12 | ITT population included all randomized participants who took at least 1 dose of study medication and had at least one post-randomization efficacy assessment on any efficacy scale. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure for each group respectively. | Units on 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.
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