NCT01113710

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 687 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Idiopathic Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	Neupro®	Neupro® is the exposure/intervention of interest in this non-interventional study.

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-04-30
• Last updated: 2012-09-28
• Results posted: 2012-09-28

Locations

80 sites across 1 country: Germany