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

UCB

Status

Completed

Conditions

Idiopathic Restless Legs Syndrome

Treatments

Drug: Neupro®

Study type

Observational

Funder types

Industry

Identifiers

NCT01113710

SP0948

Details and patient eligibility

About

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.

Full 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.

Enrollment

687 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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