Effect on RLS Symptom Severity After Switching to Neupro® in Patients Who Previously Experienced Augmentation

Study Overview
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Brief Summary
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The objective is to assess the effect of Neupro® on the severity of Restless Leg Syndrome (RLS) symptoms and augmentation in patients with augmentation associated with previous oral dopaminergic therapy. In addition, the change in treatment regimen used when switching to Neupro® will be evaluated.

Official Title
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Non Interventional Observational Study to Collect Data for the Effect of Switching to Neupro® on Severity of Restless Leg Syndrome (RLS) Symptoms and Augmentation as Well as the Change in Treatment Regimen Used, in RLS Patients With Previous Augmentation

Conditions
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Restless Legs Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The adult patient has a diagnosis of moderate to severe idiopathic Restless Leg Syndrome (RLS) The patient must be experiencing augmentation due to a prior dopaminergic treatment The decision to prescribe Neupro® has been made by the physician independently of his/her decision to enroll the patient in the study Patient 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: Patients diagnosed with secondary Restless Leg Syndrome (RLS) should not be enrolled in this observational study

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® Treatment<br>Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 2 | The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale: = Normal, not ill at all = Borderline ill = Mildly ill = Moderately ill = Markedly ill = Severely ill = Among the most extremely ill subjects A negative change from Baseline to Visit 2 indicates an improvement in CGI Item 1. | From Baseline up to 7 days | 
| Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 3 | The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale: = Normal, not ill at all = Borderline ill = Mildly ill = Moderately ill = Markedly ill = Severely ill = Among the most extremely ill subjects A negative change from Baseline to Visit 3 indicates an improvement in CGI Item 1. | From Baseline up to 28 days | 
| Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 4 | The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale: = Normal, not ill at all = Borderline ill = Mildly ill = Moderately ill = Markedly ill = Severely ill = Among the most extremely ill subjects A negative change from Baseline to Visit 4 indicates an improvement in CGI Item 1. | From Baseline up to 4 months | 
| Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 5 | The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale: = Normal, not ill at all = Borderline ill = Mildly ill = Moderately ill = Markedly ill = Severely ill = Among the most extremely ill subjects A negative change from Baseline to Visit 2 indicates an improvement in CGI Item 1. | From Baseline up to 7 months | 
| Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 6 | The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale: = Normal, not ill at all = Borderline ill = Mildly ill = Moderately ill = Markedly ill = Severely ill = Among the most extremely ill subjects A negative change from Baseline to Visit 6 indicates an improvement in CGI Item 1. | From Baseline up to 10 months | 
| Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 7 | The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale: = Normal, not ill at all = Borderline ill = Mildly ill = Moderately ill = Markedly ill = Severely ill = Among the most extremely ill subjects A negative change from Baseline to Visit 7 indicates an improvement in CGI Item 1. | From Baseline up to 13 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Treatment Regimen Used for Switching to Neupro® up to 28 Days After Entering in the Study | Case reports from clinical practice refer to different switching regimens for patients taking oral dopaminergics who experienced augmentation and then switched to Neupro®. The previous dopaminergic treatment might have been partly or completely down-titrated prior to switching to Neupro®. Physicians were requested to document the change of treatment at each recommended visit in the electronic Case Report Form (eCRF) considering their total clinical experience with this particular Restless Legs Syndrome (RLS) patients population. Documentation comprised changes in the RLS medication last prescribed, and the dosage of Neupro® and concomitant medications. The change of treatment regimen was entirely at the physicians' discretion. | From Baseline up to 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotigotine, Neupro®, Augmentation, Restless Legs Syndrome, Moderate to severe, idiopathic, adults