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, Inc.
ClinicalTrials.gov Identifier:
NCT01113710
First received: April 28, 2010
Last updated: August 28, 2012
Last verified: August 2012
  Purpose

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 Intervention
Idiopathic Restless Legs Syndrome
Drug: Neupro®

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • 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).



Secondary Outcome Measures:
  • 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).



Enrollment: 687
Study Start Date: May 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01113710

  Show 80 Study Locations
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided by UCB, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT01113710     History of Changes
Other Study ID Numbers: SP0948
Study First Received: April 28, 2010
Results First Received: July 6, 2012
Last Updated: August 28, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by UCB, Inc.:
Rotigotine
Neupro®
Restless Legs Syndrome

Additional relevant MeSH terms:
Restless Legs Syndrome
Psychomotor Agitation
Nervous System Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Parasomnias
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
N 0437
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014