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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.


Clinical Trial 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. ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01113710
Study type Observational
Source UCB Pharma
Contact
Status Completed
Phase N/A
Start date May 2010
Completion date July 2011

See also
  Status Clinical Trial Phase
Completed NCT00390689 - A Randomised, Comparing Fixed Doses of Pramipexole to Investigate the Efficacy and Safety in Patients With RLS. Phase 3
Completed NCT00666965 - A Placebo-Controlled Study for SPM 962 in Restless Legs Syndrome (RLS) Patients Phase 2
Completed NCT00498108 - Phase 3 Open-label Extension Trial With Rotigotine in Idiopathic Restless Legs Syndrome Subjects Phase 3
Completed NCT01084551 - Study of SPM 962 in Patients With Restless Legs Syndrome (RLS) Phase 3
Completed NCT00806026 - Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients Phase 3
Completed NCT01562743 - A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome Phase 2