Trial · NCT01113710

Non-interventional Study (NIS) in Patients With Restless Legs Syndrome in Daily Practise

NCT01113710, Completed, UCB Pharma; results first posted 2012-09-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Non-interventional Study (NIS) in Patients With Restless Legs Syndrome in Daily Practise. Trials, record NCT01113710. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01113710

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Non-interventional Study (NIS) in Patients With Restless Legs Syndrome in Daily Practise
NCT number: NCT01113710
Status: Completed
Enrollment: 687 participants, actual
Lead sponsor: UCB Pharma
Conditions: Idiopathic Restless Legs Syndrome
Interventions: Neupro®
First posted: 2010-04-30
Last updated: 2012-09-28
Results first posted: 2012-09-28

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Severity of Restless Legs Syndrome (RLS) at Bedtime	From Baseline to end of Observation Period (3 months).	Severity of RLS at bedtime measured as change from baseline to end of observation period (Item 2 RLS-6 scale). The Last Observation Carried Forward (LOCF) method was utilized for all outcomes. The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities).
Primary	Severity of Restless Legs Syndrome (RLS) During the Night	From Baseline to end of Observation Period (3 months).	Severity of RLS during the night measured as change from baseline to end of observation period (Item 3 RLS-6 scale). The Last Observation Carried Forward (LOCF) method was utilized for all outcomes. The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities).
Secondary	Satisfaction With Sleep	From Baseline to end of Observation Period (3 months).	Satisfaction with sleep measured as change from baseline to end of observation period (Item 1 RLS-6 scale). The Last Observation Carried Forward (LOCF) method was utilized for all outcomes. The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities).
Secondary	Severity of Restless Legs Syndrome (RLS) at Daytime at Rest	From Baseline to end of Observation Period (3 months).	Severity of RLS at daytime at rest measured as change from baseline to end of observation period (Item 4 RLS-6 scale). The Last Observation Carried Forward (LOCF) method was utilized for all outcomes. The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities).
Secondary	Severity of Restless Legs Syndrome (RLS) at Daytime in Activity	From Baseline to end of Observation Period (3 months).	Severity of RLS at daytime in activity measured as change from baseline to end of observation period (Item 5 RLS-6 scale). The Last Observation Carried Forward (LOCF) method was utilized for all outcomes. The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities).
Secondary	Daytime Tiredness	From Baseline to end of Observation Period (3 months).	Daytime tiredness measured as change from baseline to end of observation period (Item 6 RLS-6 scale). The Last Observation Carried Forward (LOCF) method was utilized for all outcomes. The RLS-6 scale is an 11-point scale (from 0 = not present/completely satisfied to 10 = very severe/completely dissatisfied) to establish an individual severity profile at various day and night times (at bedtime; during the night; during the day when the patients are resting, or during the day when the patients are involved in daily activities).

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Severity of Restless Legs Syndrome (RLS) at Bedtime	From Baseline to end of Observation Period (3 months).	Of the 564 subjects in the Full Analysis Set (FAS), 564 are included in this analysis.~The FAS consists of all patients receiving treatment with Rotigotine at least once \& for whom valid scores for item 2 \& item 3 of the RLS-6 scale at baseline \& at least one valid post baseline score for both item 2 \& item 3 of the RLS-6 scale is documented.	units on a scale	MEAN
PRIMARY	Severity of Restless Legs Syndrome (RLS) During the Night	From Baseline to end of Observation Period (3 months).	Of the 564 subjects in the Full Analysis Set (FAS), 564 are included in this analysis.~The FAS consists of all patients receiving treatment with Rotigotine at least once \& for whom valid scores for item 2 \& item 3 of the RLS-6 scale at baseline \& at least one valid post baseline score for both item 2 \& item 3 of the RLS-6 scale is documented.	units on a scale	MEAN
SECONDARY	Satisfaction With Sleep	From Baseline to end of Observation Period (3 months).	Of the 564 subjects in the Full Analysis Set (FAS), 564 are included in this analysis.~The FAS consists of all patients receiving treatment with Rotigotine at least once \& for whom valid scores for item 2 \& item 3 of the RLS-6 scale at baseline \& at least one valid post baseline score for both item 2 \& item 3 of the RLS-6 scale is documented.	units on a scale	MEAN
SECONDARY	Severity of Restless Legs Syndrome (RLS) at Daytime at Rest	From Baseline to end of Observation Period (3 months).	Of the 564 subjects in the Full Analysis Set (FAS), 562 are included in this analysis.~The FAS consists of all patients receiving treatment with Rotigotine at least once \& for whom valid scores for item 2 \& item 3 of the RLS-6 scale at baseline \& at least one valid post baseline score for both item 2 \& item 3 of the RLS-6 scale is documented.	units on a scale	MEAN
SECONDARY	Severity of Restless Legs Syndrome (RLS) at Daytime in Activity	From Baseline to end of Observation Period (3 months).	Of the 564 subjects in the Full Analysis Set (FAS), 564 are included in this analysis.~The FAS consists of all patients receiving treatment with Rotigotine at least once \& for whom valid scores for item 2 \& item 3 of the RLS-6 scale at baseline \& at least one valid post baseline score for both item 2 \& item 3 of the RLS-6 scale is documented.	units on a scale	MEAN
SECONDARY	Daytime Tiredness	From Baseline to end of Observation Period (3 months).	Of the 564 subjects in the Full Analysis Set (FAS), 561 are included in this analysis.~The FAS consists of all patients receiving treatment with Rotigotine at least once \& for whom valid scores for item 2 \& item 3 of the RLS-6 scale at baseline \& at least one valid post baseline score for both item 2 \& item 3 of the RLS-6 scale is documented.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Severity of Restless Legs Syndrome (RLS) at Bedtime	Neupro®	Change from Baseline to End of Observation Period	-2.2	Standard Deviation 3.6	units on a scale
Severity of Restless Legs Syndrome (RLS) at Bedtime	Neupro®	Observed Value at Baseline Visit	5.2	Standard Deviation 3.2	units on a scale
Severity of Restless Legs Syndrome (RLS) During the Night	Neupro®	Change from Baseline to End of Observation Period	-2.5	Standard Deviation 3.4	units on a scale
Severity of Restless Legs Syndrome (RLS) During the Night	Neupro®	Observed Value at Baseline Visit	5.5	Standard Deviation 2.9	units on a scale
Satisfaction With Sleep	Neupro®	Change from Baseline to End of Observation Period	-2.4	Standard Deviation 3.5	units on a scale
Satisfaction With Sleep	Neupro®	Observed Value at Baseline Visit	6.4	Standard Deviation 2.7	units on a scale
Severity of Restless Legs Syndrome (RLS) at Daytime at Rest	Neupro®	Change from Baseline to End of Observation Period	-2.8	Standard Deviation 3.2	units on a scale
Severity of Restless Legs Syndrome (RLS) at Daytime at Rest	Neupro®	Observed Value at Baseline Visit	5.2	Standard Deviation 2.8	units on a scale
Severity of Restless Legs Syndrome (RLS) at Daytime in Activity	Neupro®	Change from Baseline to End of Observation Period	-0.9	Standard Deviation 2.3	units on a scale
Severity of Restless Legs Syndrome (RLS) at Daytime in Activity	Neupro®	Observed Value at Baseline Visit	1.9	Standard Deviation 2.4	units on a scale

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Neupro®	687
Overall Study	COMPLETED	Neupro®	418
Overall Study	NOT COMPLETED	Neupro®	269

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	Neupro®	39	684	39
other	Application site erythema	General disorders	Neupro®	8	684	8
other	Fatigue	General disorders	Neupro®	14	684	14
other	Headache	Nervous system disorders	Neupro®	19	684	19
other	Dizziness	Nervous system disorders	Neupro®	19	684	19
other	Sleep disorder	Psychiatric disorders	Neupro®	8	684	8
other	Dermatitis allergic	Skin and subcutaneous tissue disorders	Neupro®	14	684	14
other	Pruritus	Skin and subcutaneous tissue disorders	Neupro®	23	684	23
other	Rash	Skin and subcutaneous tissue disorders	Neupro®	15	684	16
other	Hypertension	Vascular disorders	Neupro®	7	684	7

1 to 10 of 26Source ClinicalTrials.gov

See all 26 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Neupro®
Total, other adverse events	Neupro®	121	684
Total, serious adverse events	Neupro®	8	684

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23668924	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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01113710

GET https://conductscience.org/api/trials/v1/NCT01113710/events?page=2

API reference For AI assistants