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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Non-Interventional Study (NIS) in Patients With Restless Legs Syndrome (RLS) to Assess the Effectiveness and Safety of Neupro® in Daily Practise

Conditions
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Idiopathic Restless Legs Syndrome

Intervention / Treatment
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* Drug: Neupro®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: It was recommended that the patient's treatment was in accordance with the local marketing authorization (MA) for Neupro® The patient must have a diagnosis of moderate to severe idiopathic RLS The patient is considered reliable and capable of adhering to the visit schedule or medication administration according to the judgment of the investigator The decision to prescribe the drug has been made by the physician independently of his/her decision to include the patient in the study Subject is informed and given ample time and opportunity to think about his/her participation in the study and has given written informed data consent Exclusion Criteria: Hypersensitivity to the active substance or to any of the excipients Magnetic resonance imaging or cardioversion (see SmPC)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neupro®<br>Routine treatment in accordance with the local marketing authorization for Neupro® in RLS | Drug: Neupro®<br>* Neupro® is the exposure/intervention of interest in this non-interventional study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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). | 

Secondary Outcome Measures

| Outcome Measure | 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). | 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotigotine, Neupro®, Restless Legs Syndrome