Trial · NCT01569464
Rotigotine Effect on All-day Functioning and Quality of Life in Subjects With Moderate to Severe Restless Legs Syndrome (RLS)
NCT01569464, Phase 3, Completed, UCB Pharma; results first posted 2014-08-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Rotigotine Effect on All-day Functioning and Quality of Life in Subjects With Moderate to Severe Restless Legs Syndrome (RLS). Trials, record NCT01569464. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01569464
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rotigotine Effect on All-day Functioning and Quality of Life in Subjects With Moderate to Severe Restless Legs Syndrome (RLS)
- NCT number
- NCT01569464
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 150 participants, actual
- Lead sponsor
- UCB Pharma
- Conditions
- Restless Legs Syndrome
- Interventions
- Rotigotine, Placebo
- First posted
- 2012-04-03
- Last updated
- 2014-08-26
- Results first posted
- 2014-08-26
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline To The End Of The Maintenance Period in International Restless Legs Scale (IRLS) Sum Score | Baseline to End of Maintenance Period (approximately 7 weeks) | The International Restless Legs Scale (IRLS) was intended to evaluate, in a standardized way, the subjective intensity of major symptoms of Restless Legs Syndrome (RLS) and, in 2 items (9 and 10), the impact of the disease on subjects functioning in daytime activities by use of a 5-point scale for each of a total of 10 items. In all items, the scores ranged from 0 (not present) to 4 (severe). A sum score across all 10 items was calculated for analysis, which varied between 0 (no RLS symptoms present at all) to 40 (maximum severity in all symptoms). |
| Primary | Change In Average Of Means Of Multiple Suggested Immobilization Test Discomfort Scale (m-SIT-DS) Values Of Each Individual Suggested Immobilization Test (SIT) For The Combination Of Multiple Suggested Immobilization Test (m SIT) | Baseline to End of Maintenance Period (approximately 7 weeks) | The Multiple Suggested Immobilization Test Discomfort Scale (m-SIT-DS) was used for assessment of the sensory components of Restless Legs Syndrome (RLS) symptoms in order to provide a subjective score of the severity of RLS symptoms during each Suggested Immobilization Test (SIT). Scores ranged from 0 (no symptoms) to 10 (very severe symptoms) and were assessed every 10 minutes within each SIT. |
| Secondary | Change In Average Of Means Of Periodic Limb Movement During Wakefulness Index (PLMWI) Change In Average Of Means Of Periodic Limb Movement During Wakefulness Index (PLMWI) For The Combination Of Multiple Suggested Immobilization Test (m-SIT) | Baseline to End of Maintenance Period (approximately 7 weeks) | During each single Suggested Immobilization Test (SIT) PLMWI was measured using a validated actigraphy device. Simultaneous actigraphy of the legs was performed by an actigraphy device, which was attached to the ankle prior to the start of the SIT. The PLMWI was recorded while the subject was awake. Scores ranged from 0 (no symptoms) to 10 (very severe symptoms) and were assessed every 10 minutes within each SIT. |
| Secondary | Change In Item Score From Baseline To The End Of The Maintenance Period In Satisfaction With Sleep (Item 1 of Restless Legs Syndrome 6 Rating Scales [RLS-6]) | Baseline to End of Maintenance Period (approximately 7 weeks) | The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = completely satisfied) to (10 = completely dissatisfied). |
| Secondary | Change In Item Score From Baseline To The End Of The Maintenance Period In Severity Of Restless Legs Syndrome (RLS) At Bedtime (Item 2 of Restless Legs Syndrome 6 Rating Scales [RLS-6]) | Baseline to End of Maintenance Period (approximately 7 weeks) | The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = none) to (10 = very severe). |
| Secondary | Change In Item Score From Baseline To The End Of The Maintenance Period In Severity Of Restless Legs Syndrome (RLS) During The Night (Item 3 of Restless Legs Syndrome 6 Rating Scales [RLS-6]) | Baseline to End of Maintenance Period (approximately 7 weeks) | The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = none) to (10 = very severe). |
| Secondary | Change In Item Score From Baseline To The End Of The Maintenance Period In Severity Of Restless Legs Syndrome (RLS) At Daytime At Rest (Item 4 of Restless Legs Syndrome 6 Rating Scales [RLS-6]) | Baseline to End of Maintenance Period (approximately 7 weeks) | The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = none) to (10 = very severe). |
| Secondary | Change In Item Score From Baseline To The End Of The Maintenance Period In Severity of Restless Legs Syndrome (RLS) At Daytime In Activity (Item 5 of Restless Legs Syndrome 6 Rating Scales [RLS-6]) | Baseline to End of Maintenance Period (approximately 7 weeks) | The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = none) to (10 = very severe). |
| Secondary | Change In Item Score From Baseline To The End Of The Maintenance Period In Daytime Tiredness (Item 6 of Restless Legs Syndrome 6 Rating Scales [RLS-6]) | Baseline to End of Maintenance Period (approximately 7 weeks) | The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = not at all) to (10 = very severe). |
| Secondary | Change From Baseline To The End Of Maintenance Period In Daytime Somnolence Domain Score Of The Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R) | Baseline to End of Maintenance Period (approximately 7 weeks) | The Medical Outcomes Study (MOS) Sleep Scale-Revised (MOS Sleep-R) is a self-administered questionnaire measuring several important aspects of sleep that have been validated in both general and patient populations. The MOS Sleep-R consists of 12-items. Responses for 10 of the 12 items are on a 5-point frequency scale with options ranging from "all of the time" to "none of the time". The other two items ask about the length of time to fall asleep and the average number of hours slept per night. The sleep problems index I allows for the summary of sleep problems using an abbreviated six-item index, whereas the sleep problems index II uses nine of the 12 items of the scale to compute an overall sleep problem summary. A higher score on each scale in summary index represents a lack of sleep problems (better sleep quality). All scores are transformed linearly to range from 0 to 100, with the exception of the sleep quantity subscale, which is scored in hours. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline To The End Of The Maintenance Period in International Restless Legs Scale (IRLS) Sum Score | Baseline to End of Maintenance Period (approximately 7 weeks) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables. | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change In Average Of Means Of Multiple Suggested Immobilization Test Discomfort Scale (m-SIT-DS) Values Of Each Individual Suggested Immobilization Test (SIT) For The Combination Of Multiple Suggested Immobilization Test (m SIT) | Baseline to End of Maintenance Period (approximately 7 weeks) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change In Average Of Means Of Periodic Limb Movement During Wakefulness Index (PLMWI) Change In Average Of Means Of Periodic Limb Movement During Wakefulness Index (PLMWI) For The Combination Of Multiple Suggested Immobilization Test (m-SIT) | Baseline to End of Maintenance Period (approximately 7 weeks) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 149 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change In Item Score From Baseline To The End Of The Maintenance Period In Satisfaction With Sleep (Item 1 of Restless Legs Syndrome 6 Rating Scales [RLS-6]) | Baseline to End of Maintenance Period (approximately 7 weeks) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change In Item Score From Baseline To The End Of The Maintenance Period In Severity Of Restless Legs Syndrome (RLS) At Bedtime (Item 2 of Restless Legs Syndrome 6 Rating Scales [RLS-6]) | Baseline to End of Maintenance Period (approximately 7 weeks) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change In Item Score From Baseline To The End Of The Maintenance Period In Severity Of Restless Legs Syndrome (RLS) During The Night (Item 3 of Restless Legs Syndrome 6 Rating Scales [RLS-6]) | Baseline to End of Maintenance Period (approximately 7 weeks) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change In Item Score From Baseline To The End Of The Maintenance Period In Severity Of Restless Legs Syndrome (RLS) At Daytime At Rest (Item 4 of Restless Legs Syndrome 6 Rating Scales [RLS-6]) | Baseline to End of Maintenance Period (approximately 7 weeks) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change In Item Score From Baseline To The End Of The Maintenance Period In Severity of Restless Legs Syndrome (RLS) At Daytime In Activity (Item 5 of Restless Legs Syndrome 6 Rating Scales [RLS-6]) | Baseline to End of Maintenance Period (approximately 7 weeks) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change In Item Score From Baseline To The End Of The Maintenance Period In Daytime Tiredness (Item 6 of Restless Legs Syndrome 6 Rating Scales [RLS-6]) | Baseline to End of Maintenance Period (approximately 7 weeks) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline To The End Of Maintenance Period In Daytime Somnolence Domain Score Of The Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R) | Baseline to End of Maintenance Period (approximately 7 weeks) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline To The End Of The Maintenance Period in International Restless Legs Scale (IRLS) Sum Score | Rotigotine | -15.46 | Standard Error 1.00 | units on a scale | |
| Change From Baseline To The End Of The Maintenance Period in International Restless Legs Scale (IRLS) Sum Score | Placebo | -15.19 | Standard Error 1.29 | units on a scale | |
Change In Average Of Means Of Multiple Suggested Immobilization Test Discomfort Scale (m-SIT-DS) Values Of Each Individual Suggested Immobilization Test (SIT) For The Combination Of Multiple Suggested Immobilization Test (m SIT) | Rotigotine | -2.83 | Standard Error 0.25 | units on a scale | |
Change In Average Of Means Of Multiple Suggested Immobilization Test Discomfort Scale (m-SIT-DS) Values Of Each Individual Suggested Immobilization Test (SIT) For The Combination Of Multiple Suggested Immobilization Test (m SIT) | Placebo | -2.90 | Standard Error 0.33 | units on a scale | |
Change In Average Of Means Of Periodic Limb Movement During Wakefulness Index (PLMWI) Change In Average Of Means Of Periodic Limb Movement During Wakefulness Index (PLMWI) For The Combination Of Multiple Suggested Immobilization Test (m-SIT) | Rotigotine | -48.05 | Standard Error 6.25 | units on a scale | |
Change In Average Of Means Of Periodic Limb Movement During Wakefulness Index (PLMWI) Change In Average Of Means Of Periodic Limb Movement During Wakefulness Index (PLMWI) For The Combination Of Multiple Suggested Immobilization Test (m-SIT) | Placebo | -56.39 | Standard Error 8.03 | units on a scale | |
| Change In Item Score From Baseline To The End Of The Maintenance Period In Satisfaction With Sleep (Item 1 of Restless Legs Syndrome 6 Rating Scales [RLS-6]) | Rotigotine | -3.44 | Standard Error 0.40 | units on a scale | |
| Change In Item Score From Baseline To The End Of The Maintenance Period In Satisfaction With Sleep (Item 1 of Restless Legs Syndrome 6 Rating Scales [RLS-6]) | Placebo | -3.93 | Standard Error 0.51 | units on a scale | |
| Change In Item Score From Baseline To The End Of The Maintenance Period In Severity Of Restless Legs Syndrome (RLS) At Bedtime (Item 2 of Restless Legs Syndrome 6 Rating Scales [RLS-6]) | Rotigotine | -4.62 | Standard Error 0.31 | units on a scale | |
| Change In Item Score From Baseline To The End Of The Maintenance Period In Severity Of Restless Legs Syndrome (RLS) At Bedtime (Item 2 of Restless Legs Syndrome 6 Rating Scales [RLS-6]) | Placebo | -4.46 | Standard Error 0.40 | units on a scale |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rotigotine | 101 | |
| Overall Study | STARTED | Placebo | 49 | |
| Overall Study | COMPLETED | Rotigotine | 91 | |
| Overall Study | COMPLETED | Placebo | 44 | |
| Overall Study | NOT COMPLETED | Rotigotine | 10 | |
| Overall Study | NOT COMPLETED | Placebo | 5 |
Source ClinicalTrials.gov
Adverse events20
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 | Rotigotine | 16 | 101 | 19 |
| other | Nausea | Gastrointestinal disorders | Placebo | 3 | 49 | 3 |
| other | Vomiting | Gastrointestinal disorders | Rotigotine | 6 | 101 | 7 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 1 | 49 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Rotigotine | 4 | 101 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 4 | 49 | 4 |
| other | Application site pruritus | General disorders | Rotigotine | 12 | 101 | 15 |
| other | Application site pruritus | General disorders | Placebo | 2 | 49 | 2 |
| other | Headache | Nervous system disorders | Rotigotine | 10 | 101 | 13 |
| other | Headache | Nervous system disorders | Placebo | 5 | 49 | 9 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rotigotine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Rotigotine | 42 | 101 |
| Total, other adverse events | Placebo | 21 | 49 |
| Total, serious adverse events | Rotigotine | 2 | 101 |
| Total, serious adverse events | Placebo | 0 | 49 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26569149 | DERIVED |
Source PubMed
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/NCT01569464
GET https://conductscience.org/api/trials/v1/NCT01569464/results?page=2