Non-interventional Study (NIS) in Patients With Restless Legs Syndrome in Daily Practise
RLS-Practise
Non-Interventional Study (NIS) in Patients With Restless Legs Syndrome (RLS) to Assess the Effectiveness and Safety of Neupro® in Daily Practise
1 other identifier
observational
687
1 country
80
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2010
80 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2010
CompletedFirst Posted
Study publicly available on registry
April 30, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
September 28, 2012
CompletedSeptember 28, 2012
August 1, 2012
1.2 years
April 28, 2010
July 6, 2012
August 28, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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).
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).
Secondary Outcomes (4)
Satisfaction With Sleep
From Baseline to end of Observation Period (3 months).
Severity of Restless Legs Syndrome (RLS) at Daytime at Rest
From Baseline to end of Observation Period (3 months).
Severity of Restless Legs Syndrome (RLS) at Daytime in Activity
From Baseline to end of Observation Period (3 months).
Daytime Tiredness
From Baseline to end of Observation Period (3 months).
Study Arms (1)
Neupro®
Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
Interventions
Neupro® is the exposure/intervention of interest in this non-interventional study.
Eligibility Criteria
Adult patients with a diagnosis of moderate to severe idiopathic RLS treated with Neupro® in routine daily practice.
You may qualify if:
- 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
You may not qualify if:
- Hypersensitivity to the active substance or to any of the excipients
- Magnetic resonance imaging or cardioversion (see SmPC)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (80)
Unknown Facility
Abensburg, Germany
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Altenholz, Germany
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Alzenau in Unterfranken, Germany
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Anklam, Germany
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Aschaffenburg, Germany
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Bad Neustadt an der Saale, Germany
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Berlin, Germany
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Bielefeld, Germany
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Bischofswerda, Germany
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Bochum, Germany
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Bonn, Germany
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Böblingen, Germany
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Bremen, Germany
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Cologne, Germany
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Cottbus, Germany
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Delbrück, Germany
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Dippoldiswalde, Germany
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Dortmund-Kirchhörde, Germany
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Dresden, Germany
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Düren, Germany
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Ellwangen, Germany
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Erbach im Odenwald, Germany
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Freiburg im Breisgau, Germany
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Fulda, Germany
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Gelsenkirchen, Germany
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Gera, Germany
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Gladenbach, Germany
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Göttingen, Germany
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Greifswald, Germany
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Gütersloh, Germany
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Halle, Germany
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Heidenheim, Germany
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Ilmenau, Germany
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Jülich, Germany
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Karlsruhe, Germany
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Karlstadt am Main, Germany
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Kassel, Germany
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Kaufbeuren, Germany
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Kleve, Germany
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Königsbrück, Germany
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Leipzig, Germany
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Lemgo, Germany
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Leun-Biskirchen, Germany
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Lippstadt, Germany
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Lohr a. Main, Germany
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Ludwigsfelde, Germany
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Malchin, Germany
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Mannheim, Germany
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Marburg, Germany
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Marburg-Cappel, Germany
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München, Germany
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Neuburg an der Donau, Germany
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Neusäß, Germany
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Oberursel, Germany
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Oelde, Germany
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Osnabrück, Germany
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Osterode am Harz, Germany
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Paderborn, Germany
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Potsdam, Germany
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Remscheid, Germany
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Rheda-Wiedenbrück, Germany
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Rostock, Germany
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Schriesheim, Germany
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Schwalmstadt-Treysa, Germany
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Schwäbisch Gmünd, Germany
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Schwedt, Germany
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Schwerin, Germany
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Senftenberg, Germany
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Soest, Germany
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Stadtroda, Germany
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Stralsund, Germany
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Stuttgart, Germany
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Teupitz, Germany
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Ulm, Germany
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Westerstede, Germany
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Wiesbaden, Germany
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Wismar, Germany
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Wolfsburg, Germany
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Zschadrass, Germany
Unknown Facility
Zwickau, Germany
Related Publications (1)
Stiasny-Kolster K, Berg D, Hofmann WE, Berkels R, Grieger F, Lauterbach T, Schollmayer E, Bachmann CG. Effectiveness and tolerability of rotigotine transdermal patch for the treatment of restless legs syndrome in a routine clinical practice setting in Germany. Sleep Med. 2013 Jun;14(6):475-81. doi: 10.1016/j.sleep.2013.02.013. Epub 2013 May 11.
PMID: 23668924DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB (Study Director)
- Organization
- UCB Clinical Trial Call Center
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2010
First Posted
April 30, 2010
Study Start
May 1, 2010
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
September 28, 2012
Results First Posted
September 28, 2012
Record last verified: 2012-08