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

Idiopathic Restless Legs Syndrome Clinical Trial

— RLS-Practise  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01113710
• Other study ID #: SP0948
• Status: Completed
• Phase: N/A
• First received: April 28, 2010
• Last updated: August 28, 2012
• Start date: May 2010
• Est. completion date: July 2011

Study information

• Verified date: August 2012
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 687
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Idiopathic Restless Legs Syndrome
• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

Drug:
• Neupro®
Neupro® is the exposure/intervention of interest in this non-interventional study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	From Baseline to end of Observation Period (3 months).	No
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).	From Baseline to end of Observation Period (3 months).	No
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).	From Baseline to end of Observation Period (3 months).	No
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).	From Baseline to end of Observation Period (3 months).	No
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).	From Baseline to end of Observation Period (3 months).	No
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).	From Baseline to end of Observation Period (3 months).	No