Skip to main content
OpenTrials
Completed

NCT Number: NCT01113710

Non-interventional Study (NIS) in Patients With Restless Legs Syndrome 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Idiopathic Restless Legs Syndrome Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Restless Legs Syndrome Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Abensburg, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Neupro®

Drug

Neupro® is the exposure/intervention of interest in this non-interventional study.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

Non-Interventional Study (NIS) in Patients With Restless Legs Syndrome (RLS) to Assess the Effectiveness and Safety of Neupro® in Daily Practise

Acronym: RLS-Practise

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 30, 2010
Registry last updated
Sep 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.