ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01386944
Recruitment Status : Completed
First Posted : July 1, 2011
Results First Posted : August 15, 2014
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Brief Summary:
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.

Condition or disease
Restless Legs Syndrome

Study Type : Observational
Actual Enrollment : 102 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Study Start Date : July 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

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

Group/Cohort
Neupro® Treatment
Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).



Primary Outcome Measures :
  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:

    1. = Normal, not ill at all
    2. = Borderline ill
    3. = Mildly ill
    4. = Moderately ill
    5. = Markedly ill
    6. = Severely ill
    7. = 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:

    1. = Normal, not ill at all
    2. = Borderline ill
    3. = Mildly ill
    4. = Moderately ill
    5. = Markedly ill
    6. = Severely ill
    7. = 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:

    1. = Normal, not ill at all
    2. = Borderline ill
    3. = Mildly ill
    4. = Moderately ill
    5. = Markedly ill
    6. = Severely ill
    7. = 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:

    1. = Normal, not ill at all
    2. = Borderline ill
    3. = Mildly ill
    4. = Moderately ill
    5. = Markedly ill
    6. = Severely ill
    7. = 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:

    1. = Normal, not ill at all
    2. = Borderline ill
    3. = Mildly ill
    4. = Moderately ill
    5. = Markedly ill
    6. = Severely ill
    7. = 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:

    1. = Normal, not ill at all
    2. = Borderline ill
    3. = Mildly ill
    4. = Moderately ill
    5. = Markedly ill
    6. = Severely ill
    7. = Among the most extremely ill subjects

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



Secondary Outcome Measures :
  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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult patient with a diagnosis of moderate to severe idiopathic Restless Leg Syndrome (RLS).

Patient must be experiencing augmentation due to a prior dopaminergic treatment.

Every consecutive, eligible patient to be treated with Neupro® as per physician's decision.

Criteria

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

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): NCT01386944


Locations
Germany
12
Berlin, Germany
4
Bremen, Germany
18
Dresden, Germany
20
Flensburg, Germany
1
Kassel, Germany
11
Marburg, Germany
17
Marburg, Germany
2
Mönchengladbach, Germany
6
Münster, Germany
7
Regensburg, Germany
21
Remscheid, Germany
15
Schriesheim, Germany
10
Schwalmstadt, Germany
3
Schwerin, Germany
8
Tuebingen, Germany
16
Ulm, Germany
9
Ulm, Germany
19
Westerstede, Germany
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)

Publications of Results:
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01386944     History of Changes
Other Study ID Numbers: SP1009
First Posted: July 1, 2011    Key Record Dates
Results First Posted: August 15, 2014
Last Update Posted: April 4, 2018
Last Verified: March 2018

Keywords provided by UCB Pharma:
Rotigotine
Neupro®
Augmentation
Restless Legs Syndrome
Moderate to severe
idiopathic
adults

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