Clinical trial NCT01386944: Effect on RLS Symptom Severity After Switching to Neupro® in Patients Who Previously Experienced Augmentation
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Restless Legs Syndrome
Keywords: Rotigotine
Neupro®
Augmentation
Restless Legs Syndrome
Moderate to severe
idiopathic
adults
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2011-07-01
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 2
timeFrame: From Baseline up to 7 days
measure: Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 3
timeFrame: From Baseline up to 28 days
measure: Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 4
timeFrame: From Baseline up to 4 months
measure: Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 5
timeFrame: From Baseline up to 7 months
measure: Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 6
timeFrame: From Baseline up to 10 months
measure: Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 7
timeFrame: From Baseline up to 13 months
Secondary outcomes:
measure: Change in Treatment Regimen Used for Switching to Neupro® up to 28 Days After Entering in the Study
timeFrame: From Baseline up to 28 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: 12
city: Bremen
country: Germany
facility: 4
city: Dresden
country: Germany
facility: 18
city: Flensburg
country: Germany
facility: 20
city: Kassel
country: Germany
facility: 1
city: Marburg
country: Germany
facility: 11
city: Marburg
country: Germany
facility: 17
city: Mönchengladbach
country: Germany
facility: 2
city: Münster
country: Germany
facility: 6
city: Regensburg
country: Germany
facility: 7
city: Remscheid
country: Germany
facility: 21
city: Schriesheim
country: Germany
facility: 15
city: Schwalmstadt
country: Germany
facility: 10
city: Schwerin
country: Germany
facility: 3
city: Tuebingen
country: Germany
facility: 8
city: Ulm
country: Germany
facility: 16
city: Ulm
country: Germany
facility: 9
city: Westerstede
country: Germany
facility: 19
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: 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.sleep.2015.10.006. Epub 2015 Nov 11.