Trial · NCT01537042
A Sleep Laboratory Study to Investigate the Safety and Efficacy of the Rotigotine Skin Patch in Subjects With Restless Legs Syndrome and End-Stage Renal Disease Requiring Hemodialysis
NCT01537042, Phase 3, Completed, UCB BIOSCIENCES GmbH; results first posted 2014-11-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Sleep Laboratory Study to Investigate the Safety and Efficacy of the Rotigotine Skin Patch in Subjects With Restless Legs Syndrome and End-Stage Renal Disease Requiring Hemodialysis. Trials, record NCT01537042. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01537042
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Sleep Laboratory Study to Investigate the Safety and Efficacy of the Rotigotine Skin Patch in Subjects With Restless Legs Syndrome and End-Stage Renal Disease Requiring Hemodialysis
- NCT number
- NCT01537042
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 30 participants, actual
- Lead sponsor
- UCB BIOSCIENCES GmbH
- Conditions
- Restless Legs Syndrome, End-Stage Renal Disease
- Interventions
- Rotigotine, Placebo
- First posted
- 2012-02-22
- Last updated
- 2014-11-03
- Other registries' IDs
- eudract:2011-003486-15
- Results first posted
- 2014-11-03
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | The PLMI is defined as Periodic Limb Movements (PLMs)/ total time in bed in hours. PLMs are measured by Polysomnography (PSG). The reduction of the PLMI is reflected in terms of the ratio from Baseline to the end of the Maintenance Period and was calculated as \[PLMI at end of Maintenance Period (MP)\] / \[PLMI at Baseline\]. A PLMI Ratio \<1 indicates an improvement from Baseline to the end of the 2-week MP. |
| 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 | The PLMI is defined as Periodic Limb Movements (PLMs)/ total time in bed in hours. PLMs are measured by Polysomnography (PSG). A negative value in change from Baseline indicates an improvement from Baseline to the end of the Maintenance Period. |
| 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 | The IRLS is a subject based scale that consists of 10 items to evaluate the severity of major RLS symptoms and the impact of the disease on subjects' functioning in daytime activities. Each of the 10 items is measured on a scale that ranges from 0 (not present) to 4 (severe). A sum score between 0 (no RLS symptoms present at all) and 40 (maximum severity in all symptoms) across all 10 items will be calculated. A negative value in Change from Baseline indicates an improvement from Baseline in IRLS. |
| Secondary | Change From Baseline in Clinical Global Impressions (CGI) Item 1 Score | Visit 2 (Baseline); Visit 6 (End of Maintence Period) | The CGI Item 1 score measures the severity of illness on a scale that ranges from 0 (Not assessed) to 7 (Among the most extremely ill). |
| 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 | The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness. Scale 1 measures satisfaction with sleep during the last seven nights on an 11-point scale that ranges between 0 (completely satisfied) to 10 (completely dissatisfied). The ratings are given by the subjects. A negative value in Change from Baseline indicates an improvement from Baseline. |
| 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 | The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness. Scale 2 measures the severity of RLS symptoms during the last 7 nights in the situation of falling asleep. This is measured on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in Change from Baseline indicates an improvement from Baseline. |
| 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 | The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness. Scale 3 measures the severity of RLS symptoms during the last seven nights on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in Change from Baseline indicates an improvement from Baseline. |
| 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 | The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness. Scale 4 measures the severity of RLS symptoms during the last seven days at rest on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in Change from Baseline indicates an improvement from Baseline. |
| 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 | The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness. Scale 5 measures the severity of RLS symptoms during the last seven days engaged in activities on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in Change from Baseline indicates an improvement from Baseline. |
| 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 | The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness. Scale 6 measures the severity of daytime tiredness/ sleepiness on an 11-point scale that ranges between 0 (not at all) to 10 (very severe). The ratings are given by the subjects. A negative value in Change from Baseline indicates an improvement from Baseline. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Ratio From Baseline to the End of the 2-week Maintenance Period in Periodic Limb Movement Index (PLMI) | Placebo | 1.16 | 95% Confidence Interval 0.68 to 1.99 | ratio | |
| Ratio From Baseline to the End of the 2-week Maintenance Period in Periodic Limb Movement Index (PLMI) | Rotigotine | 0.51 | 95% Confidence Interval 0.33 to 0.80 | ratio | |
| Change From Baseline in the Periodic Limb Movements Index (PLMI) to the End of the Maintenance Period | Placebo | 10.3 | Standard Deviation 21 | movement/ hour | |
| Change From Baseline in the Periodic Limb Movements Index (PLMI) to the End of the Maintenance Period | Rotigotine | -23.7 | Standard Deviation 38.7 | movement/ hour | |
| Change From Baseline in the International Restless Legs Syndrome Study Group Rating Scale (IRLS) Sum Score to the End of the Maintenance Period | Placebo | -8.6 | Standard Deviation 7.2 | units on a scale | |
| Change From Baseline in the International Restless Legs Syndrome Study Group Rating Scale (IRLS) Sum Score to the End of the Maintenance Period | Rotigotine | -15.9 | Standard Deviation 9.1 | units on a scale | |
| Change From Baseline in Clinical Global Impressions (CGI) Item 1 Score | Placebo (Visit 2) | Not assessed | 0 | participants | |
| Change From Baseline in Clinical Global Impressions (CGI) Item 1 Score | Rotigotine (Visit 2) | Not assessed | 0 | participants | |
| Change From Baseline in Clinical Global Impressions (CGI) Item 1 Score | Placebo (Visit 6) | Not assessed | 0 | participants | |
| Change From Baseline in Clinical Global Impressions (CGI) Item 1 Score | Rotigotine (Visit 6) | Not assessed | 0 | participants |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 10 | |
| Overall Study | STARTED | Rotigotine | 20 | |
| Overall Study | COMPLETED | Placebo | 10 | |
| Overall Study | COMPLETED | Rotigotine | 15 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Rotigotine | 5 |
Source ClinicalTrials.gov
Adverse events68
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Eye haemorrhage | Eye disorders | Placebo | 0 | 10 | 0 |
| other | Eye haemorrhage | Eye disorders | Rotigotine | 1 | 20 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 2 | 10 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Rotigotine | 1 | 20 | 1 |
| other | Constipation | Gastrointestinal disorders | Placebo | 0 | 10 | 0 |
| other | Constipation | Gastrointestinal disorders | Rotigotine | 1 | 20 | 1 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Placebo | 0 | 10 | 0 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Rotigotine | 1 | 20 | 1 |
| other | Nausea | Gastrointestinal disorders | Placebo | 0 | 10 | 0 |
| other | Nausea | Gastrointestinal disorders | Rotigotine | 4 | 20 | 5 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Rotigotine | ||
| Total, other adverse events | Placebo | 4 | 10 |
| Total, other adverse events | Rotigotine | 12 | 20 |
| Total, serious adverse events | Placebo | 1 | 10 |
| Total, serious adverse events | Rotigotine | 3 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Rotigotine vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01537042
GET https://conductscience.org/api/trials/v1/NCT01537042/results?page=2