Trial · NCT01455012
Effects of Neupro on Cardiovascular Observations in Patients With Restless Legs Syndrome
NCT01455012, Phase 4, Completed, UCB BIOSCIENCES GmbH; results first posted 2013-07-18
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Effects of Neupro on Cardiovascular Observations in Patients With Restless Legs Syndrome. Trials, record NCT01455012. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01455012
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Neupro on Cardiovascular Observations in Patients With Restless Legs Syndrome
- NCT number
- NCT01455012
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 81 participants, actual
- Lead sponsor
- UCB BIOSCIENCES GmbH
- Conditions
- Restless Legs Syndrome
- Interventions
- Rotigotine, Placebo
- First posted
- 2011-10-19
- Last updated
- 2013-07-26
- Other registries' IDs
- eudract:2011-000053-23
- Results first posted
- 2013-07-18
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Number of Elevations of Systolic Blood Pressure (BP) During the Night That Are Associated With Periodic Limb Movements (PLMs) at the End of the 4-week Maintenance Period | Baseline to the end of the 4-week Maintenance Period | Polysomnography (PSG) recordings, including the assessment of continuous Blood Pressure and 12-lead Electrocardiogram (ECG), were obtained on 2 consecutive nights prior to Baseline Visit and prior to End of Maintenance Period (Visit 7) for up to 8 hours per night. Readings from the first night of the PSG were only used for analysis if the PSG from the second night was determined to be not valid for evaluation. Influence of Periodic Limb Movements (PLMs) on sleep is reflected in the Periodic Limb Movement-Related Arousal Index (PLMAI). Arousal is defined as sudden change in the EEG activity and the index illustrates to what degree the PLMs contribute to arousal from sleep. Sleep stages and time spent in each sleep stage were determined from Electroencephalogram (EEG) readings. A negative value in Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement. |
| Secondary | Change From Baseline in the Total Number of Elevations of Systolic Blood Pressure (BP) During the Night at the End of the 4-week Maintenance Period | Baseline to the end of the 4-week Maintenance Period | Polysomnography (PSG) recordings, including the assessment of continuous Blood Pressure and 12-lead Electrocardiogram (ECG), were obtained on 2 consecutive nights prior to Baseline Visit and prior to End of Maintenance Period (Visit 7) for up to 8 hours per night. Readings from the first night of the PSG were only used for analysis if the PSG from the second night was determined to be not valid for evaluation. Influence of Periodic Limb Movements (PLMs) on sleep is reflected in the Periodic Limb Movement-Related Arousal Index (PLMAI). Arousal is defined as sudden change in the EEG activity and the index illustrates to what degree the PLMs contribute to arousal from sleep. Sleep stages and time spent in each sleep stage were determined from Electroencephalogram (EEG) readings. A negative value in Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement. |
| Secondary | Change From Baseline in the Periodic Limb Movements Index (PLMI) at the End of the 4-week Maintenance Period | Baseline to the end of the 4-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 PLMI Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement. |
| Secondary | Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at the End of the 4-week Maintenance Period | Baseline to the end of the 4-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' daytime functioning. 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 was calculated. A negative value in IRLS Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement. |
| Secondary | Change From Baseline in Restless Legs Syndrome-Quality of Life (RLS-QoL) at the End of the 4-week Maintenance Period | Baseline to the end of the 4-week Maintenance Period | The RLS-QoL is a disease-specific instrument for the evaluation of Quality of life. It consists of 12 items and the overall sum score is calculated from all 12 items and measured on a scale that ranges from 0 (lowest Quality of life) to 60 (highest level of Quality of life). A negative value in RLS-QoL Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement. |
| Secondary | Clinical Global Impressions (CGI) Item 2 (Change of Condition) at the End of the 4-week Maintenance Period | At the end of the 4-week Maintenance Period | The CGI Item 2 score measures any change in severity of RLS from Baseline on a 7-point scale consisting of the following categories: * 1- Very much improved * 2- Much improved * 3- Minimally improved * 4- No change * 5- Minimally worse * 6- Much worse * 7- Very much worse |
| Secondary | Clinical Global Impressions (CGI) Item 1 (Severity of Illness) at the End of the 4-week Maintenance Period | At the end of the 4-week Maintenance Period | The CGI Item 1 score measures the severity of illness on a 7-point scale consisting of the following categories: * 1- Normal, not ill at all * 2- Borderline ill * 3- Mildly ill * 4- Moderately ill * 5- Markedly ill * 6- Severely ill * 7- Among the most extremely ill subjects |
| Secondary | Clinical Global Impressions (CGI) Item 3 (Therapeutic Efficacy) at the End of the 4-week Maintenance Period | At the end of the 4-week Maintenance Period | The CGI Item 3 score measures the therapeutic efficacy on a 4-point scale consisting of the following categories: * 1- Very good * 2- Moderate * 3- Slight * 4- Unchanged or worse |
| Secondary | Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 1 at the End of the 4-week Maintenance Period | Baseline to the end of the 4-week Maintenance Period | The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 1 measures subject's satisfaction with sleep on a 11-point scale that ranges between 0 (completely satisfied) to 10 (completely dissatisfied). The ratings are given by the subjects. A negative value in RLS-6 Item 6 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement. |
| Secondary | Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 2 at the End of the 4-week Maintenance Period | Baseline to the end of the 4-week Maintenance Period | The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 2 measures the severity of RLS at time falling asleep on a 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in RLS-6 Item 2 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Number of Elevations of Systolic Blood Pressure (BP) During the Night That Are Associated With Periodic Limb Movements (PLMs) at the End of the 4-week Maintenance Period | Baseline to the end of the 4-week Maintenance Period | Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure. | Nocturnal Elevations of Systolic BP | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Total Number of Elevations of Systolic Blood Pressure (BP) During the Night at the End of the 4-week Maintenance Period | Baseline to the end of the 4-week Maintenance Period | Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure. | Nocturnal Elevations of Systolic BP | MEAN |
| SECONDARY | Change From Baseline in the Periodic Limb Movements Index (PLMI) at the End of the 4-week Maintenance Period | Baseline to the end of the 4-week Maintenance Period | Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure. | Periodic Limb Movements/hour | MEAN |
| SECONDARY | Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at the End of the 4-week Maintenance Period | Baseline to the end of the 4-week Maintenance Period | Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Restless Legs Syndrome-Quality of Life (RLS-QoL) at the End of the 4-week Maintenance Period | Baseline to the end of the 4-week Maintenance Period | Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure. | units on a scale | MEAN |
| SECONDARY | Clinical Global Impressions (CGI) Item 2 (Change of Condition) at the End of the 4-week Maintenance Period | At the end of the 4-week Maintenance Period | Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure. | participants | NUMBER |
| SECONDARY | Clinical Global Impressions (CGI) Item 1 (Severity of Illness) at the End of the 4-week Maintenance Period | At the end of the 4-week Maintenance Period | Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure. | participants | NUMBER |
| SECONDARY | Clinical Global Impressions (CGI) Item 3 (Therapeutic Efficacy) at the End of the 4-week Maintenance Period | At the end of the 4-week Maintenance Period | Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure. | participants | NUMBER |
| SECONDARY | Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 1 at the End of the 4-week Maintenance Period | Baseline to the end of the 4-week Maintenance Period | Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 2 at the End of the 4-week Maintenance Period | Baseline to the end of the 4-week Maintenance Period | Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure. | units on a scale | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Number of Elevations of Systolic Blood Pressure (BP) During the Night That Are Associated With Periodic Limb Movements (PLMs) at the End of the 4-week Maintenance Period | Placebo | -79.61 | 95% Confidence Interval 189.3 | Nocturnal Elevations of Systolic BP | |
| Change From Baseline in the Number of Elevations of Systolic Blood Pressure (BP) During the Night That Are Associated With Periodic Limb Movements (PLMs) at the End of the 4-week Maintenance Period | Rotigotine | -239.95 | 95% Confidence Interval 237.1 | Nocturnal Elevations of Systolic BP | |
| Change From Baseline in the Total Number of Elevations of Systolic Blood Pressure (BP) During the Night at the End of the 4-week Maintenance Period | Placebo | -34.3 | Standard Deviation 243.4 | Nocturnal Elevations of Systolic BP | |
| Change From Baseline in the Total Number of Elevations of Systolic Blood Pressure (BP) During the Night at the End of the 4-week Maintenance Period | Rotigotine | -199.8 | Standard Deviation 262.8 | Nocturnal Elevations of Systolic BP | |
| Change From Baseline in the Periodic Limb Movements Index (PLMI) at the End of the 4-week Maintenance Period | Placebo | -15.2 | Standard Deviation 50.3 | Periodic Limb Movements/hour | |
| Change From Baseline in the Periodic Limb Movements Index (PLMI) at the End of the 4-week Maintenance Period | Rotigotine | -50.1 | Standard Deviation 44.5 | Periodic Limb Movements/hour | |
| Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at the End of the 4-week Maintenance Period | Placebo | -12.5 | Standard Deviation 9.0 | units on a scale | |
| Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at the End of the 4-week Maintenance Period | Rotigotine | -18.5 | Standard Deviation 8.0 | units on a scale | |
| Change From Baseline in Restless Legs Syndrome-Quality of Life (RLS-QoL) at the End of the 4-week Maintenance Period | Placebo | -11.0 | Standard Deviation 11.9 | units on a scale | |
| Change From Baseline in Restless Legs Syndrome-Quality of Life (RLS-QoL) at the End of the 4-week Maintenance Period | Rotigotine | -17.8 | Standard Deviation 13.2 | units on a scale |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 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 | 41 | |
| Overall Study | STARTED | Rotigotine | 40 | |
| Overall Study | COMPLETED | Placebo | 30 | |
| Overall Study | COMPLETED | Rotigotine | 36 | |
| Overall Study | NOT COMPLETED | Placebo | 11 | |
| Overall Study | NOT COMPLETED | Rotigotine | 4 |
Source ClinicalTrials.gov
Adverse events26
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 | Nausea | Gastrointestinal disorders | Placebo | 3 | 40 | 3 |
| other | Nausea | Gastrointestinal disorders | Rotigotine | 9 | 40 | 11 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 3 | 40 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Rotigotine | 0 | 40 | 0 |
| other | Fatigue | General disorders | Placebo | 6 | 40 | 6 |
| other | Fatigue | General disorders | Rotigotine | 5 | 40 | 5 |
| other | Application site pruritus | General disorders | Placebo | 0 | 40 | 0 |
| other | Application site pruritus | General disorders | Rotigotine | 2 | 40 | 2 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 3 | 40 | 5 |
| other | Nasopharyngitis | Infections and infestations | Rotigotine | 7 | 40 | 8 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 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 | 19 | 40 |
| Total, other adverse events | Rotigotine | 23 | 40 |
| Total, serious adverse events | Placebo | 0 | 40 |
| Total, serious adverse events | Rotigotine | 0 | 40 |
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/NCT01455012
GET https://conductscience.org/api/trials/v1/NCT01455012/results?page=2