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

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ClinicalTrials.gov Identifier: NCT01113710
Recruitment Status : Completed
First Posted : April 30, 2010
Results First Posted : September 28, 2012
Last Update Posted : September 28, 2012
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

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.

Condition or disease Intervention/treatment
Idiopathic Restless Legs Syndrome 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
Actual Enrollment : 687 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Interventional Study (NIS) in Patients With Restless Legs Syndrome (RLS) to Assess the Effectiveness and Safety of Neupro® in Daily Practise
Study Start Date : May 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs
Drug Information available for: Rotigotine

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.




Primary Outcome Measures :
  1. Severity of Restless Legs Syndrome (RLS) at Bedtime [ Time Frame: From Baseline to end of Observation Period (3 months). ]

    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).


  2. Severity of Restless Legs Syndrome (RLS) During the Night [ Time Frame: From Baseline to end of Observation Period (3 months). ]

    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).



Secondary Outcome Measures :
  1. Satisfaction With Sleep [ Time Frame: From Baseline to end of Observation Period (3 months). ]

    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).


  2. Severity of Restless Legs Syndrome (RLS) at Daytime at Rest [ Time Frame: From Baseline to end of Observation Period (3 months). ]

    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).


  3. Severity of Restless Legs Syndrome (RLS) at Daytime in Activity [ Time Frame: From Baseline to end of Observation Period (3 months). ]

    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).


  4. Daytime Tiredness [ Time Frame: From Baseline to end of Observation Period (3 months). ]

    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).




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01113710


  Hide Study Locations
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-Cappel, Germany
Marburg, 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
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01113710     History of Changes
Other Study ID Numbers: SP0948
First Posted: April 30, 2010    Key Record Dates
Results First Posted: September 28, 2012
Last Update Posted: September 28, 2012
Last Verified: August 2012

Keywords provided by UCB Pharma:
Rotigotine
Neupro®
Restless Legs Syndrome

Additional relevant MeSH terms:
Syndrome
Psychomotor Agitation
Restless Legs Syndrome
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Parasomnias
Mental Disorders
Rotigotine
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs