N/A
Completed N=687
Non-interventional Study (NIS) in Patients With Restless Legs Syndrome in Daily Practise
Idiopathic Restless Legs Syndrome
Source: ClinicalTrials.gov NCT01113710 ↗
Enrolled (actual)
687
Serious AEs
1.2%
Results posted
Sep 2012
Primary outcomePrimary: Severity of Restless Legs Syndrome (RLS) at Bedtime — -2.2; 5.2 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Severity of Restless Legs Syndrome (RLS) at Bedtime |
-2.2; 5.2 | — |
| PRIMARY Severity of Restless Legs Syndrome (RLS) During the Night |
-2.5; 5.5 | — |
| SECONDARY Satisfaction With Sleep |
-2.4; 6.4 | — |
| SECONDARY Severity of Restless Legs Syndrome (RLS) at Daytime at Rest |
-2.8; 5.2 | — |
| SECONDARY Severity of Restless Legs Syndrome (RLS) at Daytime in Activity |
-0.9; 1.9 | — |
| SECONDARY Daytime Tiredness |
-1.9; 5.1 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01113710). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.