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

• Severity of Restless Legs Syndrome (RLS) at Bedtime [ Time Frame: From Baseline to end of Observation Period (3 months). ] [ Designated as safety issue: No ]

  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).

• Severity of Restless Legs Syndrome (RLS) During the Night [ Time Frame: From Baseline to end of Observation Period (3 months). ] [ Designated as safety issue: No ]

  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).

• Severity of RLS at bedtime [ Time Frame: Change from baseline to end of observation period (3 months) ] [ Designated as safety issue: No ]
  Severity of RLS at bedtime measured as change from baseline to end of observation period (Item 2 RLS-6 scale)
• Severity of RLS during the night [ Time Frame: Change from baseline to end of observation period (3 months) ] [ Designated as safety issue: No ]
  Severity of RLS during the night measured as change from baseline to end of observation period (Item 3 RLS-6 scale)

• Satisfaction With Sleep [ Time Frame: From Baseline to end of Observation Period (3 months). ] [ Designated as safety issue: No ]

  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).

• Severity of Restless Legs Syndrome (RLS) at Daytime at Rest [ Time Frame: From Baseline to end of Observation Period (3 months). ] [ Designated as safety issue: No ]

  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).

• Severity of Restless Legs Syndrome (RLS) at Daytime in Activity [ Time Frame: From Baseline to end of Observation Period (3 months). ] [ Designated as safety issue: No ]

  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).

• Daytime Tiredness [ Time Frame: From Baseline to end of Observation Period (3 months). ] [ Designated as safety issue: No ]

  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).

• Satisfaction with sleep [ Time Frame: Change from baseline to end of observation period (3 months) ] [ Designated as safety issue: No ]
  Satisfaction with sleep measured as change from baseline to end of observation period (Item 1 RLS-6 scale)
• Severity of RLS at daytime at rest [ Time Frame: Change from baseline to end of observation period (3 months) ] [ Designated as safety issue: No ]
  Severity of RLS at daytime at rest measured as change from baseline to end of observation period (Item 4 RLS-6 scale)
• Severity of RLS at daytime in activity [ Time Frame: Change from baseline to end of observation period (3 months) ] [ Designated as safety issue: No ]
  Severity of RLS at daytime in activity measured as change from baseline to end of observation period (Item 5 RLS-6 scale)
• Daytime tiredness [ Time Frame: Change from baseline to end of observation period (3 months) ] [ Designated as safety issue: No ]
  Daytime tiredness measured as change from baseline to end of observation period (Item 6 RLS-6 scale)

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.

Adult patients with a diagnosis of moderate to severe idiopathic RLS treated with Neupro® in routine daily practice.

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)