Effect on RLS Symptom Severity After Switching to Neupro® in Patients Who Previously Experienced Augmentation (AURORA)
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| ClinicalTrials.gov Identifier: NCT01386944 |
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Recruitment Status :
Completed
First Posted : July 1, 2011
Results First Posted : August 15, 2014
Last Update Posted : April 4, 2018
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| Condition or disease |
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| 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 |
| Group/Cohort |
|---|
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Neupro® Treatment
Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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 |
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.
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
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
Show 18 study locations
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
| Responsible Party: | UCB Pharma |
| ClinicalTrials.gov Identifier: | NCT01386944 |
| 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 |
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Rotigotine Neupro® Augmentation Restless Legs Syndrome |
Moderate to severe idiopathic adults |
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Psychomotor Agitation Restless Legs Syndrome Syndrome Disease Pathologic Processes Dyskinesias Neurologic Manifestations Nervous System Diseases |
Psychomotor Disorders Neurobehavioral Manifestations Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Parasomnias Mental Disorders |