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

Restless Legs Syndrome Clinical Trial

— AURORA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01386944
• Other study ID #: SP1009
• Status: Completed
• First received: June 29, 2011
• Last updated: March 9, 2018
• Start date: July 2011
• Est. completion date: August 2013

Study information

• Verified date: March 2018
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Trenkwalder C, Canelo M, Lang M, Schroeder H, Kelling D, Berkels R, Schollmayer E, Heidbrede T, Benes H. Management of augmentation of restless legs syndrome with rotigotine: a 1-year observational study. Sleep Med. 2017 Feb;30:257-265. doi: 10.1016/j.sle — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: = 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.	From Baseline up to 7 days
Primary	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: = 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.	From Baseline up to 28 days
Primary	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: = 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.	From Baseline up to 4 months
Primary	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: = 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.	From Baseline up to 7 months
Primary	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: = 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.	From Baseline up to 10 months
Primary	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: = 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.	From Baseline up to 13 months
Secondary	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.	From Baseline up to 28 days