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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT01113710
First received: April 28, 2010
Last updated: August 28, 2012
Last verified: August 2012

April 28, 2010
August 28, 2012
May 2010
July 2011   (final data collection date for primary outcome measure)
  • Severity of Restless Legs Syndrome (RLS) at Bedtime [ Time Frame: From Baseline to end of Observation Period (3 months). ] [ Designated as safety issue: No ]

    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).

  • Severity of Restless Legs Syndrome (RLS) During the Night [ Time Frame: From Baseline to end of Observation Period (3 months). ] [ Designated as safety issue: No ]

    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).

  • Severity of RLS at bedtime [ Time Frame: Change from baseline to end of observation period (3 months) ] [ Designated as safety issue: No ]
    Severity of RLS at bedtime measured as change from baseline to end of observation period (Item 2 RLS-6 scale)
  • Severity of RLS during the night [ Time Frame: Change from baseline to end of observation period (3 months) ] [ Designated as safety issue: No ]
    Severity of RLS during the night measured as change from baseline to end of observation period (Item 3 RLS-6 scale)
Complete list of historical versions of study NCT01113710 on ClinicalTrials.gov Archive Site
  • Satisfaction With Sleep [ Time Frame: From Baseline to end of Observation Period (3 months). ] [ Designated as safety issue: No ]

    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).

  • Severity of Restless Legs Syndrome (RLS) at Daytime at Rest [ Time Frame: From Baseline to end of Observation Period (3 months). ] [ Designated as safety issue: No ]

    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).

  • Severity of Restless Legs Syndrome (RLS) at Daytime in Activity [ Time Frame: From Baseline to end of Observation Period (3 months). ] [ Designated as safety issue: No ]

    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).

  • Daytime Tiredness [ Time Frame: From Baseline to end of Observation Period (3 months). ] [ Designated as safety issue: No ]

    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).

  • Satisfaction with sleep [ Time Frame: Change from baseline to end of observation period (3 months) ] [ Designated as safety issue: No ]
    Satisfaction with sleep measured as change from baseline to end of observation period (Item 1 RLS-6 scale)
  • Severity of RLS at daytime at rest [ Time Frame: Change from baseline to end of observation period (3 months) ] [ Designated as safety issue: No ]
    Severity of RLS at daytime at rest measured as change from baseline to end of observation period (Item 4 RLS-6 scale)
  • Severity of RLS at daytime in activity [ Time Frame: Change from baseline to end of observation period (3 months) ] [ Designated as safety issue: No ]
    Severity of RLS at daytime in activity measured as change from baseline to end of observation period (Item 5 RLS-6 scale)
  • Daytime tiredness [ Time Frame: Change from baseline to end of observation period (3 months) ] [ Designated as safety issue: No ]
    Daytime tiredness measured as change from baseline to end of observation period (Item 6 RLS-6 scale)
Not Provided
Not Provided
 
Non-interventional Study (NIS) in Patients With Restless Legs Syndrome in Daily 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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Idiopathic Restless Legs Syndrome
Drug: Neupro®
Neupro® is the exposure/intervention of interest in this non-interventional study.
Neupro®
Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
Intervention: Drug: Neupro®
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
687
July 2011
July 2011   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01113710
SP0948
No
UCB Pharma
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP