Clinical trial NCT01113710: Non-interventional Study (NIS) in Patients With Restless Legs Syndrome in Daily Practise
Official title: Non-Interventional Study (NIS) in Patients With Restless Legs Syndrome (RLS) to Assess the Effectiveness and Safety of Neupro® in Daily Practise
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Restless Legs Syndrome
Keywords: Rotigotine
Neupro®
Restless Legs Syndrome
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2010-04-30
Enrollment: 687
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with a diagnosis of moderate to severe idiopathic RLS treated with Neupro® in routine daily practice.

Brief summary: This non-interventional observational study is designed to gain data for Neupro® in restless legs syndrome (RLS) under real life conditions in line with the summary of product characteristics (SmPC) related to effectiveness, tolerability and switching practice from other dopaminergic drugs as well as titration schemes.

Detailed description: There is a total of 64 subjects recorded as having discontinued due to Adverse Events. Documentation of Visit 2 and Visit 3, where the reason for discontinuation was documented, was not available for all subjects. From the documentation on the Adverse Events page in the Case Report Form, it is known that 100 subjects discontinued due to Adverse Events.

The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.

Eligibility criteria: Inclusion Criteria:

* It was recommended that the patient's treatment was in accordance with the local marketing authorization (MA) for Neupro®
* The patient must have a diagnosis of moderate to severe idiopathic RLS
* The patient is considered reliable and capable of adhering to the visit schedule or medication administration according to the judgment of the investigator
* The decision to prescribe the drug has been made by the physician independently of his/her decision to include the patient in the study
* Subject 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:

* Hypersensitivity to the active substance or to any of the excipients
* Magnetic resonance imaging or cardioversion (see SmPC)

Primary outcomes:
measure: Severity of Restless Legs Syndrome (RLS) at Bedtime
timeFrame: From Baseline to end of Observation Period (3 months).
measure: Severity of Restless Legs Syndrome (RLS) During the Night
timeFrame: From Baseline to end of Observation Period (3 months).
Secondary outcomes:
measure: Satisfaction With Sleep
timeFrame: From Baseline to end of Observation Period (3 months).
measure: Severity of Restless Legs Syndrome (RLS) at Daytime at Rest
timeFrame: From Baseline to end of Observation Period (3 months).
measure: Severity of Restless Legs Syndrome (RLS) at Daytime in Activity
timeFrame: From Baseline to end of Observation Period (3 months).
measure: Daytime Tiredness
timeFrame: From Baseline to end of Observation Period (3 months).
Other outcomes:
Locations:
city: Abensburg
country: Germany
city: Altenholz
country: Germany
city: Alzenau
country: Germany
city: Anklam
country: Germany
city: Aschaffenburg
country: Germany
city: Bad Neustadt
country: Germany
city: Berlin
country: Germany
city: Bielefeld
country: Germany
city: Bischofswerda
country: Germany
city: Bochum
country: Germany
city: Bonn
country: Germany
city: Bremen
country: Germany
city: Böblingen
country: Germany
city: Cottbus
country: Germany
city: Delbrück
country: Germany
city: Dippoldiswalde
country: Germany
city: Dortmund-Kirchhörde
country: Germany
city: Dresden
country: Germany
city: Düren
country: Germany
city: Ellwangen
country: Germany
city: Erbach
country: Germany
city: Freiburg
country: Germany
city: Fulda
country: Germany
city: Gelsenkirchen
country: Germany
city: Gera
country: Germany
city: Gladenbach
country: Germany
city: Greifswald
country: Germany
city: Göttingen
country: Germany
city: Gütersloh
country: Germany
city: Halle
country: Germany
city: Heidenheim
country: Germany
city: Ilmenau
country: Germany
city: Jülich
country: Germany
city: Karlsruhe
country: Germany
city: Karlstadt
country: Germany
city: Kassel
country: Germany
city: Kaufbeuren
country: Germany
city: Kleve
country: Germany
city: Köln
country: Germany
city: Königsbrück
country: Germany
city: Leipzig
country: Germany
city: Lemgo
country: Germany
city: Leun-Biskirchen
country: Germany
city: Lippstadt
country: Germany
city: Lohr am Main
country: Germany
city: Ludwigsfelde
country: Germany
city: Malchin
country: Germany
city: Mannheim
country: Germany
city: Marburg-Cappel
country: Germany
city: Marburg
country: Germany
city: München
country: Germany
city: Neuburg/Donau
country: Germany
city: Neusäß
country: Germany
city: Oberursel
country: Germany
city: Oelde
country: Germany
city: Osnabrück
country: Germany
city: Osterode am Harz
country: Germany
city: Paderborn
country: Germany
city: Potsdam
country: Germany
city: Remscheid
country: Germany
city: Rheda-Wiedenbrück
country: Germany
city: Rostock
country: Germany
city: Schriesheim
country: Germany
city: Schwalmstadt-Treysa
country: Germany
city: Schwedt/Oder
country: Germany
city: Schwerin
country: Germany
city: Schwäbisch Gmünd
country: Germany
city: Senftenberg
country: Germany
city: Soest
country: Germany
city: Stadtroda
country: Germany
city: Stralsund
country: Germany
city: Stuttgart
country: Germany
city: Teupitz
country: Germany
city: Ulm
country: Germany
city: Westerstede
country: Germany
city: Wiesbaden
country: Germany
city: Wismar
country: Germany
city: Wolfsburg
country: Germany
city: Zschadraß
country: Germany
city: Zwickau
country: Germany
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Stiasny-Kolster K, Berg D, Hofmann WE, Berkels R, Grieger F, Lauterbach T, Schollmayer E, Bachmann CG. Effectiveness and tolerability of rotigotine transdermal patch for the treatment of restless legs syndrome in a routine clinical practice setting in Germany. Sleep Med. 2013 Jun;14(6):475-81. doi: 10.1016/j.sleep.2013.02.013. Epub 2013 May 11.