Trial · NCT01537042
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Ratio From Baseline to the End of the 2-week Maintenance Period in Periodic Limb Movement Index (PLMI) | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period | Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period. | ratio | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Periodic Limb Movements Index (PLMI) to the End of the Maintenance Period | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period | Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period. | movement/ hour | MEAN |
| SECONDARY | Change From Baseline in the International Restless Legs Syndrome Study Group Rating Scale (IRLS) Sum Score to the End of the Maintenance Period | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period | Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Clinical Global Impressions (CGI) Item 1 Score | Visit 2 (Baseline); Visit 6 (End of Maintence Period) | Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period. | participants | NUMBER |
| SECONDARY | Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 1 to the End of the Maintenance Period | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period | Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 2 to the End of the Maintenance Period | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period | Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 3 to the End of the Maintenance Period | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period | Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 4 to the End of the Maintenance Period | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period | Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 5 to the End of the Maintenance Period | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period | Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 6 to the End of the Maintenance Period | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period | Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Periodic Limb Movement During Sleep Arousal Index (PLMSAI) to the End of the Maintenance Period | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period | Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period. | movement per hour | MEAN |
| SECONDARY | Change From Baseline in Sleep Efficiency to the End of the Maintenance Period | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period | Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period. | sleep time/ total time in bed | MEAN |
| SECONDARY | Change From Baseline in the Restless Legs-Quality of Life (RLS-QoL) Total Score to the End of the Maintenance Period | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period | Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in the Short-Form-36 (SF-36) Item Questionnaire Mental Component Summary (MCS) to the End of the Maintenance Period | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period | Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Short-Form-36 (SF-36) Item Questionnaire Physical Component Summary (PCS) to the End of the Maintenance Period | From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period | Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period. | units on a 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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01537042/outcomes