N/A
Completed N=102
Effect on RLS Symptom Severity After Switching to Neupro® in Patients Who Previously Experienced Augmentation
Source: ClinicalTrials.gov NCT01386944 ↗Enrolled (actual)
102
Serious AEs
9.1%
Results posted
Aug 2014
Primary outcomePrimary: Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 2 — -0.8 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 2 |
-0.8 | — |
| PRIMARY Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 3 |
-1.4 | — |
| PRIMARY Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 4 |
-1.8 | — |
| PRIMARY Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 5 |
-2.0 | — |
| PRIMARY Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 6 |
-2.0 | — |
| PRIMARY Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 7 |
-1.8 | — |
| SECONDARY Change in Treatment Regimen Used for Switching to Neupro® up to 28 Days After Entering in the Study |
5; 23; 9; 6 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01386944). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.