Trial Outcomes & Findings for Non-interventional Study (NIS) in Patients With Restless Legs Syndrome in Daily Practise (NCT NCT01113710)
NCT ID: NCT01113710
Last Updated: 2012-09-28
Results Overview
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).
COMPLETED
687 participants
From Baseline to end of Observation Period (3 months).
2012-09-28
Participant Flow
This study started in May 2010 with subjects from Germany. The study completed in July 2011. The Full Analysis Set is used for study outcome measures. The Enrolled Set is reflected in the Participant Flow and Study Demographics. Age demographic information is missing for 1 subject and gender information is missing for 5 subjects.
The Participant Flow contains single and multiple reasons for "Other" subject discontinuation. Therefore, individual "Other" reasons are listed below: Augmentation: 7 Problems with adhesiveness of patch: 6 Pruritus: 1 Tiredness: 1 Less effective than previous medication: 1 Application site reactions: 2 Neurotic: 1
Participant milestones
| Measure |
Neupro®
Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
|
|---|---|
|
Overall Study
STARTED
|
687
|
|
Overall Study
COMPLETED
|
418
|
|
Overall Study
NOT COMPLETED
|
269
|
Reasons for withdrawal
| Measure |
Neupro®
Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
|
|---|---|
|
Overall Study
Adverse Event
|
64
|
|
Overall Study
Lack of Efficacy
|
41
|
|
Overall Study
No Information Available
|
40
|
|
Overall Study
Withdrawal by Subject
|
28
|
|
Overall Study
Lost to Follow-up
|
20
|
|
Overall Study
Lack of Efficacy/Withdrawal by Subject
|
13
|
|
Overall Study
Withdrawal by Subject/Adverse Event
|
11
|
|
Overall Study
Lack of Patient's Compliance
|
8
|
|
Overall Study
Other
|
7
|
|
Overall Study
Adverse Event/Other
|
5
|
|
Overall Study
Patient's Compliance/Lost to Follow up
|
5
|
|
Overall Study
Lack of Efficacy/Other
|
4
|
|
Overall Study
Patient Compliance/Withdrawal by Subject
|
4
|
|
Overall Study
Lack of Efficacy/Adverse Event
|
3
|
|
Overall Study
Efficacy/Subject Withdrawal/AE
|
2
|
|
Overall Study
Compliance/Lost to Follow up/Pt Withdraw
|
2
|
|
Overall Study
Lost to Follow up/Withdrawal by Subject
|
2
|
|
Overall Study
Efficacy/Withdrawal by Subject/Other
|
1
|
|
Overall Study
Compliance/Efficacy/Adverse Event
|
1
|
|
Overall Study
Compliance/Efficacy/AE/Other
|
1
|
|
Overall Study
Compliance/Efficacy/Subject Withdrawal
|
1
|
|
Overall Study
Compliance/Lost to Follow up/Efficacy/AE
|
1
|
|
Overall Study
Lack of Patient's Compliance/Other
|
1
|
|
Overall Study
Compliance/Subject Withdrawal/AE
|
1
|
|
Overall Study
Subject Did Not Receive Neupro
|
3
|
Baseline Characteristics
Non-interventional Study (NIS) in Patients With Restless Legs Syndrome in Daily Practise
Baseline characteristics by cohort
| Measure |
Neupro®
n=687 Participants
Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
|
|---|---|
|
Age Continuous
|
65.6 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Age, Customized
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Customized
Between 18 and 65 years
|
278 Participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
408 Participants
n=5 Participants
|
|
Age, Customized
Missing
|
1 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
494 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
188 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Missing
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
687 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline to end of Observation Period (3 months).Population: 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.
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).
Outcome measures
| Measure |
Neupro®
n=564 Participants
Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
|
|---|---|
|
Severity of Restless Legs Syndrome (RLS) at Bedtime
Change from Baseline to End of Observation Period
|
-2.2 units on a scale
Standard Deviation 3.6
|
|
Severity of Restless Legs Syndrome (RLS) at Bedtime
Observed Value at Baseline Visit
|
5.2 units on a scale
Standard Deviation 3.2
|
PRIMARY outcome
Timeframe: From Baseline to end of Observation Period (3 months).Population: 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.
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).
Outcome measures
| Measure |
Neupro®
n=564 Participants
Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
|
|---|---|
|
Severity of Restless Legs Syndrome (RLS) During the Night
Change from Baseline to End of Observation Period
|
-2.5 units on a scale
Standard Deviation 3.4
|
|
Severity of Restless Legs Syndrome (RLS) During the Night
Observed Value at Baseline Visit
|
5.5 units on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: From Baseline to end of Observation Period (3 months).Population: 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.
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).
Outcome measures
| Measure |
Neupro®
n=564 Participants
Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
|
|---|---|
|
Satisfaction With Sleep
Change from Baseline to End of Observation Period
|
-2.4 units on a scale
Standard Deviation 3.5
|
|
Satisfaction With Sleep
Observed Value at Baseline Visit
|
6.4 units on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: From Baseline to end of Observation Period (3 months).Population: 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.
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).
Outcome measures
| Measure |
Neupro®
n=562 Participants
Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
|
|---|---|
|
Severity of Restless Legs Syndrome (RLS) at Daytime at Rest
Change from Baseline to End of Observation Period
|
-2.8 units on a scale
Standard Deviation 3.2
|
|
Severity of Restless Legs Syndrome (RLS) at Daytime at Rest
Observed Value at Baseline Visit
|
5.2 units on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: From Baseline to end of Observation Period (3 months).Population: 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.
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).
Outcome measures
| Measure |
Neupro®
n=564 Participants
Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
|
|---|---|
|
Severity of Restless Legs Syndrome (RLS) at Daytime in Activity
Change from Baseline to End of Observation Period
|
-0.9 units on a scale
Standard Deviation 2.3
|
|
Severity of Restless Legs Syndrome (RLS) at Daytime in Activity
Observed Value at Baseline Visit
|
1.9 units on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: From Baseline to end of Observation Period (3 months).Population: 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.
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).
Outcome measures
| Measure |
Neupro®
n=561 Participants
Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
|
|---|---|
|
Daytime Tiredness
Change from Baseline to End of Observation Period
|
-1.9 units on a scale
Standard Deviation 3.2
|
|
Daytime Tiredness
Observed Value at Baseline Visit
|
5.1 units on a scale
Standard Deviation 2.9
|
Adverse Events
Neupro®
Serious adverse events
| Measure |
Neupro®
n=684 participants at risk
Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.15%
1/684 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 3 months per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Neupro® at least once.
|
|
Cardiac disorders
Arrhythmia
|
0.15%
1/684 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 3 months per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Neupro® at least once.
|
|
Gastrointestinal disorders
Diaphragmatic hernia
|
0.15%
1/684 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 3 months per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Neupro® at least once.
|
|
Gastrointestinal disorders
Ileus
|
0.15%
1/684 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 3 months per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Neupro® at least once.
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.15%
1/684 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 3 months per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Neupro® at least once.
|
|
Infections and infestations
Herpes zoster
|
0.15%
1/684 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 3 months per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Neupro® at least once.
|
|
Infections and infestations
Pneumonia
|
0.15%
1/684 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 3 months per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Neupro® at least once.
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.15%
1/684 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 3 months per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Neupro® at least once.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.15%
1/684 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 3 months per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Neupro® at least once.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.15%
1/684 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 3 months per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Neupro® at least once.
|
|
Musculoskeletal and connective tissue disorders
Radius fracture
|
0.15%
1/684 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 3 months per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Neupro® at least once.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.15%
1/684 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 3 months per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Neupro® at least once.
|
|
Nervous system disorders
Hemiparesis
|
0.15%
1/684 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 3 months per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Neupro® at least once.
|
|
Nervous system disorders
Dysarthria
|
0.15%
1/684 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 3 months per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Neupro® at least once.
|
|
Nervous system disorders
Amaurosis fugax
|
0.15%
1/684 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 3 months per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Neupro® at least once.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.15%
1/684 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 3 months per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Neupro® at least once.
|
Other adverse events
| Measure |
Neupro®
n=684 participants at risk
Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
5.7%
39/684 • Number of events 39 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 3 months per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Neupro® at least once.
|
|
General disorders
Application site erythema
|
1.2%
8/684 • Number of events 8 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 3 months per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Neupro® at least once.
|
|
General disorders
Fatigue
|
2.0%
14/684 • Number of events 14 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 3 months per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Neupro® at least once.
|
|
Nervous system disorders
Headache
|
2.8%
19/684 • Number of events 19 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 3 months per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Neupro® at least once.
|
|
Nervous system disorders
Dizziness
|
2.8%
19/684 • Number of events 19 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 3 months per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Neupro® at least once.
|
|
Psychiatric disorders
Sleep disorder
|
1.2%
8/684 • Number of events 8 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 3 months per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Neupro® at least once.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
2.0%
14/684 • Number of events 14 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 3 months per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Neupro® at least once.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.4%
23/684 • Number of events 23 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 3 months per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Neupro® at least once.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.2%
15/684 • Number of events 16 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 3 months per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Neupro® at least once.
|
|
Vascular disorders
Hypertension
|
1.0%
7/684 • Number of events 7 • Adverse Events (AEs) were collected during the course of the trial, which was approximately 3 months per subject.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Neupro® at least once.
|
Additional Information
UCB (Study Director)
UCB Clinical Trial Call Center
Results disclosure agreements
- Principal investigator is a sponsor employee UCB has \> 60 but \<= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER