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

Completed

Conditions: Idiopathic Restless Legs Syndrome

Interventions: Drug: Neupro®

Registration Number: NCT01113710

Lead Sponsor: UCB Pharma

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 687

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)

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neupro®	Neupro®	Routine treatment in accordance with the local marketing authorization for Neupro® in RLS

Primary Outcome Measures

Name	Time	Method
Severity of Restless Legs Syndrome (RLS) at Bedtime	From Baseline to end of Observation Period (3 months).	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	From Baseline to end of Observation Period (3 months).	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).

Secondary Outcome Measures

Name	Time	Method
Satisfaction With Sleep	From Baseline to end of Observation Period (3 months).	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	From Baseline to end of Observation Period (3 months).	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	From Baseline to end of Observation Period (3 months).	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	From Baseline to end of Observation Period (3 months).	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).