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

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Restless Legs Syndrome
• Intervention / Treatment: Drug: Neupro®

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.

• Study Type: Observational
• Enrollment (Actual): 687

Contacts and Locations

Study Locations

• Germany
  • Abensburg, Germany
  • Altenholz, Germany
  • Alzenau, Germany
  • Anklam, Germany
  • Aschaffenburg, Germany
  • Bad Neustadt, Germany
  • Berlin, Germany
  • Bielefeld, Germany
  • Bischofswerda, Germany
  • Bochum, Germany
  • Bonn, Germany
  • Bremen, Germany
  • Böblingen, Germany
  • Cottbus, Germany
  • Delbrück, Germany
  • Dippoldiswalde, Germany
  • Dortmund-Kirchhörde, Germany
  • Dresden, Germany
  • Düren, Germany
  • Ellwangen, Germany
  • Erbach, Germany
  • Freiburg, Germany
  • Fulda, Germany
  • Gelsenkirchen, Germany
  • Gera, Germany
  • Gladenbach, Germany
  • Greifswald, Germany
  • Göttingen, Germany
  • Gütersloh, Germany
  • Halle, Germany
  • Heidenheim, Germany
  • Ilmenau, Germany
  • Jülich, Germany
  • Karlsruhe, Germany
  • Karlstadt, Germany
  • Kassel, Germany
  • Kaufbeuren, Germany
  • Kleve, Germany
  • Köln, Germany
  • Königsbrück, Germany
  • Leipzig, Germany
  • Lemgo, Germany
  • Leun-Biskirchen, Germany
  • Lippstadt, Germany
  • Lohr am Main, Germany
  • Ludwigsfelde, Germany
  • Malchin, Germany
  • Mannheim, Germany
  • Marburg, Germany
  • Marburg-Cappel, Germany
  • München, Germany
  • Neuburg/Donau, Germany
  • Neusäß, Germany
  • Oberursel, Germany
  • Oelde, Germany
  • Osnabrück, Germany
  • Osterode am Harz, Germany
  • Paderborn, Germany
  • Potsdam, Germany
  • Remscheid, Germany
  • Rheda-Wiedenbrück, Germany
  • Rostock, Germany
  • Schriesheim, Germany
  • Schwalmstadt-Treysa, Germany
  • Schwedt/Oder, Germany
  • Schwerin, Germany
  • Schwäbisch Gmünd, Germany
  • Senftenberg, Germany
  • Soest, Germany
  • Stadtroda, Germany
  • Stralsund, Germany
  • Stuttgart, Germany
  • Teupitz, Germany
  • Ulm, Germany
  • Westerstede, Germany
  • Wiesbaden, Germany
  • Wismar, Germany
  • Wolfsburg, Germany
  • Zschadraß, Germany
  • Zwickau, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with a diagnosis of moderate to severe idiopathic RLS treated with Neupro® in routine daily practice.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neupro®; Routine treatment in accordance with the local marketing authorization for Neupro® in RLS	Drug: Neupro®; Neupro® is the exposure/intervention of interest in this non-interventional study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction With Sleep	Satisfaction with sleep measured as change from baseline to end of observation period (Item 1 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) at Daytime at Rest	Severity of RLS at daytime at rest measured as change from baseline to end of observation period (Item 4 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) at Daytime in Activity	Severity of RLS at daytime in activity measured as change from baseline to end of observation period (Item 5 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).
Daytime Tiredness	Daytime tiredness measured as change from baseline to end of observation period (Item 6 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).

Collaborators and Investigators

• Sponsor: UCB Pharma

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: April 28, 2010
• First Submitted That Met QC Criteria: April 29, 2010
• First Posted (Estimate): April 30, 2010

Study Record Updates

• Last Update Posted (Estimate): September 28, 2012
• Last Update Submitted That Met QC Criteria: August 28, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Restless Legs Syndrome; Rotigotine; Neupro®
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Dyskinesias; Psychomotor Disorders; Parasomnias; Syndrome; Psychomotor Agitation; Restless Legs Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dopamine Agonists; Dopamine Agents; Rotigotine
• Other Study ID Numbers: SP0948