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.
Study Type
OBSERVATIONAL
Enrollment
102
12
Berlin, Germany
4
Bremen, Germany
18
Dresden, Germany
Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 2
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.
Time frame: From Baseline up to 7 days
Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 3
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.
Time frame: From Baseline up to 28 days
Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 4
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.
Time frame: From Baseline up to 4 months
Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 5
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.
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20
Flensburg, Germany
1
Kassel, Germany
11
Marburg, Germany
17
Marburg, Germany
2
Mönchengladbach, Germany
6
Münster, Germany
7
Regensburg, Germany
...and 8 more locations
Time frame: From Baseline up to 7 months
Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 6
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.
Time frame: From Baseline up to 10 months
Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 7
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.
Time frame: From Baseline up to 13 months
Change in Treatment Regimen Used for Switching to Neupro® up to 28 Days After Entering in the Study
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.
Time frame: From Baseline up to 28 days