Trial · NCT00991276
Outcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 31
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Wake After Sleep Onset (WASO) | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or Early Termination (ET) | Intent to Treat (ITT) population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Periodic Limb Movement Arousal Index (PLMAI) | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least one post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | movement/hour | LEAST_SQUARES_MEAN |
| SECONDARY | Subjective Total Sleep Time (sTST) | Week 3 and Week 5 of Each Intervention Period or ET | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Minutes of Stage N1, N2, N3 and R Sleep | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Awakenings of at Least 1 Epoch After Sleep Onset (NAASO1) | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | awakenings | LEAST_SQUARES_MEAN |
| SECONDARY | Restless Legs Syndrome-Next Day Impact (RLS-NDI) | Week 3 and Week 5 of Each Intervention Period or ET | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Periodic Limb Movement Index (PLMI) | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | movement/hour | LEAST_SQUARES_MEAN |
| SECONDARY | Periodic Limb Movement in Sleep Index (PLMSI) | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | movement/hour | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Awakenings of at Least 2 Epochs After Sleep Onset (NAASO2) | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | awakenings | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Arousals (NASO) | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | arousals | LEAST_SQUARES_MEAN |
| SECONDARY | Arousal Index (NASOI) | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | arousals/hour | LEAST_SQUARES_MEAN |
| SECONDARY | International Restless Legs Syndrome Study Group Rating Scale (IRLS) | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Response to Clinical Global Impression - Improvement (CGI-I) Scale | Baseline, Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | percentage of participants | NUMBER |
| SECONDARY | Latency to Stage R Sleep (LREM) | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Latency to Persistent Sleep (LPS) | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Wake Time During Sleep (WTDS) | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Wake Time After Sleep (WTAS) | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Total Sleep Time (TST) | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Sleep Efficiency (SE) | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Percentage of time asleep | LEAST_SQUARES_MEAN |
| SECONDARY | Hourly and Quarterly Assessment of Wake After Sleep Onset (WASO) | Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET | ITT population included set of randomized participants who had at least 1 dose of study medication and had at least 1 post-randomization efficacy assessment. Here n signifies number of participants analyzed at that particular time point for each arm group respectively. | minutes | LEAST_SQUARES_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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