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Completed

NCT Number: NCT01386944

Effect on RLS Symptom Severity After Switching to Neupro® in Patients Who Previously Experienced Augmentation

The objective is to assess the effect of Neupro® on the severity of Restless Leg Syndrome (RLS) symptoms and augmentation in patients with augmentation associated with previous oral dopaminergic therapy. In addition, the change in treatment regimen used when switching to Neupro® will be evaluated.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

12, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The adult patient has a diagnosis of moderate to severe idiopathic Restless Leg Syndrome (RLS)
  • The patient must be experiencing augmentation due to a prior dopaminergic treatment
  • The decision to prescribe Neupro® has been made by the physician independently of his/her decision to enroll the patient in the study
  • Patient 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

  • Patients diagnosed with secondary Restless Leg Syndrome (RLS) should not be enrolled in this observational study

Treatment and study plan

Primary outcomes

  1. Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 2

    Time frame: From Baseline up to 7 days

    The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:

    • = Normal, not ill at all
    • = Borderline ill
    • = Mildly ill
    • = Moderately ill
    • = Markedly ill
    • = Severely ill
    • = Among the most extremely ill subjects

    A negative change from Baseline to Visit 2 indicates an improvement in CGI Item 1.

  2. Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 3

    Time frame: From Baseline up to 28 days

    The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:

    • = Normal, not ill at all
    • = Borderline ill
    • = Mildly ill
    • = Moderately ill
    • = Markedly ill
    • = Severely ill
    • = Among the most extremely ill subjects

    A negative change from Baseline to Visit 3 indicates an improvement in CGI Item 1.

  3. Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 4

    Time frame: From Baseline up to 4 months

    The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:

    • = Normal, not ill at all
    • = Borderline ill
    • = Mildly ill
    • = Moderately ill
    • = Markedly ill
    • = Severely ill
    • = Among the most extremely ill subjects

    A negative change from Baseline to Visit 4 indicates an improvement in CGI Item 1.

  4. Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 5

    Time frame: From Baseline up to 7 months

    The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:

    • = Normal, not ill at all
    • = Borderline ill
    • = Mildly ill
    • = Moderately ill
    • = Markedly ill
    • = Severely ill
    • = Among the most extremely ill subjects

    A negative change from Baseline to Visit 2 indicates an improvement in CGI Item 1.

  5. Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 6

    Time frame: From Baseline up to 10 months

    The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:

    • = Normal, not ill at all
    • = Borderline ill
    • = Mildly ill
    • = Moderately ill
    • = Markedly ill
    • = Severely ill
    • = Among the most extremely ill subjects

    A negative change from Baseline to Visit 6 indicates an improvement in CGI Item 1.

  6. Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 7

    Time frame: From Baseline up to 13 months

    The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:

    • = Normal, not ill at all
    • = Borderline ill
    • = Mildly ill
    • = Moderately ill
    • = Markedly ill
    • = Severely ill
    • = Among the most extremely ill subjects

    A negative change from Baseline to Visit 7 indicates an improvement in CGI Item 1.

Secondary outcomes

  1. Change in Treatment Regimen Used for Switching to Neupro® up to 28 Days After Entering in the Study

    Time frame: From Baseline up to 28 days

    Case reports from clinical practice refer to different switching regimens for patients taking oral dopaminergics who experienced augmentation and then switched to Neupro®. The previous dopaminergic treatment might have been partly or completely down-titrated prior to switching to Neupro®. Physicians were requested to document the change of treatment at each recommended visit in the electronic Case Report Form (eCRF) considering their total clinical experience with this particular Restless Legs Syndrome (RLS) patients population. Documentation comprised changes in the RLS medication last prescribed, and the dosage of Neupro® and concomitant medications. The change of treatment regimen was entirely at the physicians' discretion.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

Non Interventional Observational Study to Collect Data for the Effect of Switching to Neupro® on Severity of Restless Leg Syndrome (RLS) Symptoms and Augmentation as Well as the Change in Treatment Regimen Used, in RLS Patients With Previous Augmentation

Acronym: AURORA

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 1, 2011
Registry last updated
Apr 4, 2018

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.

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