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This non-interventional observational study is designed to gain data for Neupro® in restless legs syndrome (RLS) under real life conditions in line with the summary of product characteristics (SmPC) related to effectiveness, tolerability and switching practice from other dopaminergic drugs as well as titration schemes.
There is a total of 64 subjects recorded as having discontinued due to Adverse Events. Documentation of Visit 2 and Visit 3, where the reason for discontinuation was documented, was not available for all subjects. From the documentation on the Adverse Events page in the Case Report Form, it is known that 100 subjects discontinued due to Adverse Events.
The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neupro® | Routine treatment in accordance with the local marketing authorization for Neupro® in RLS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neupro® | Drug | Neupro® is the exposure/intervention of interest in this non-interventional study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Restless Legs Syndrome (RLS) at Bedtime | 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). | From Baseline to end of Observation Period (3 months). |
| Severity of Restless Legs Syndrome (RLS) During the Night | 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). | From Baseline to end of Observation Period (3 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction With Sleep | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with a diagnosis of moderate to severe idiopathic RLS treated with Neupro® in routine daily practice.
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abensburg | Germany | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23668924 | Derived | Stiasny-Kolster K, Berg D, Hofmann WE, Berkels R, Grieger F, Lauterbach T, Schollmayer E, Bachmann CG. Effectiveness and tolerability of rotigotine transdermal patch for the treatment of restless legs syndrome in a routine clinical practice setting in Germany. Sleep Med. 2013 Jun;14(6):475-81. doi: 10.1016/j.sleep.2013.02.013. Epub 2013 May 11. |
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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
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Neupro® | Routine treatment in accordance with the local marketing authorization for Neupro® in RLS |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| From Baseline to end of Observation Period (3 months). |
| Severity of Restless Legs Syndrome (RLS) at Daytime at Rest | 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). | From Baseline to end of Observation Period (3 months). |
| Severity of Restless Legs Syndrome (RLS) at Daytime in Activity | 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). | From Baseline to end of Observation Period (3 months). |
| Daytime Tiredness | 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). | From Baseline to end of Observation Period (3 months). |
| Altenholz |
| Germany |
| Alzenau in Unterfranken | Germany |
| Anklam | Germany |
| Aschaffenburg | Germany |
| Bad Neustadt an der Saale | Germany |
| Berlin | Germany |
| Bielefeld | Germany |
| Bischofswerda | Germany |
| Bochum | Germany |
| Bonn | Germany |
| Böblingen | Germany |
| Bremen | Germany |
| Cologne | Germany |
| Cottbus | Germany |
| Delbrück | Germany |
| Dippoldiswalde | Germany |
| Dortmund-Kirchhörde | Germany |
| Dresden | Germany |
| Düren | Germany |
| Ellwangen | Germany |
| Erbach im Odenwald | Germany |
| Freiburg im Breisgau | Germany |
| Fulda | Germany |
| Gelsenkirchen | Germany |
| Gera | Germany |
| Gladenbach | Germany |
| Göttingen | Germany |
| Greifswald | Germany |
| Gütersloh | Germany |
| Halle | Germany |
| Heidenheim | Germany |
| Ilmenau | Germany |
| Jülich | Germany |
| Karlsruhe | Germany |
| Karlstadt am Main | Germany |
| Kassel | Germany |
| Kaufbeuren | Germany |
| Kleve | Germany |
| Königsbrück | Germany |
| Leipzig | Germany |
| Lemgo | Germany |
| Leun-Biskirchen | Germany |
| Lippstadt | Germany |
| Lohr a. Main | Germany |
| Ludwigsfelde | Germany |
| Malchin | Germany |
| Mannheim | Germany |
| Marburg | Germany |
| Marburg-Cappel | Germany |
| München | Germany |
| Neuburg an der Donau | Germany |
| Neusäß | Germany |
| Oberursel | Germany |
| Oelde | Germany |
| Osnabrück | Germany |
| Osterode am Harz | Germany |
| Paderborn | Germany |
| Potsdam | Germany |
| Remscheid | Germany |
| Rheda-Wiedenbrück | Germany |
| Rostock | Germany |
| Schriesheim | Germany |
| Schwalmstadt-Treysa | Germany |
| Schwäbisch Gmünd | Germany |
| Schwedt | Germany |
| Schwerin | Germany |
| Senftenberg | Germany |
| Soest | Germany |
| Stadtroda | Germany |
| Stralsund | Germany |
| Stuttgart | Germany |
| Teupitz | Germany |
| Ulm | Germany |
| Westerstede | Germany |
| Wiesbaden | Germany |
| Wismar | Germany |
| Wolfsburg | Germany |
| Zschadrass | Germany |
| Zwickau | Germany |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Neupro® | Routine treatment in accordance with the local marketing authorization for Neupro® in RLS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Customized | Number | Participants |
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| Sex/Gender, Customized | Number | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Severity of Restless Legs Syndrome (RLS) at Bedtime | 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | From Baseline to end of Observation Period (3 months). |
|
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| ||||||||||||||||||||||||||||||||
| Primary | Severity of Restless Legs Syndrome (RLS) During the Night | 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | From Baseline to end of Observation Period (3 months). |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Satisfaction With Sleep | 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | From Baseline to end of Observation Period (3 months). |
|
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| Secondary | Severity of Restless Legs Syndrome (RLS) at Daytime at Rest | 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | From Baseline to end of Observation Period (3 months). |
|
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| Secondary | Severity of Restless Legs Syndrome (RLS) at Daytime in Activity | 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | From Baseline to end of Observation Period (3 months). |
|
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| Secondary | Daytime Tiredness | 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | From Baseline to end of Observation Period (3 months). |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neupro® | Routine treatment in accordance with the local marketing authorization for Neupro® in RLS | 8 | 684 | 121 | 684 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Diaphragmatic hernia | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Reflux oesophagitis | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
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| Skeletal injury | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
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| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Radius fracture | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Cerebral ischaemia | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Hemiparesis | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Dysarthria | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Amaurosis fugax | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Application site erythema | General disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB (Study Director) | UCB Clinical Trial Call Center | +1 887 822 9493 |
| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D020447 | Parasomnias |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C047508 | rotigotine |
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| >=65 years |
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| Missing |
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| Missing |
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