Clinical trial NCT00721279: Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome
Official title: Sifrol Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary RLS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Restless Legs Syndrome
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-07-24
Enrollment: 549
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with idiopathic RLS

Brief summary: The objectives of the Post Market Surveillance (PMS) study are to evaluate the treatment effect of pramipexole on Restless Legs Syndrome (RLS) severity as measured by International Restless Legs Rating Scale and Global Clinical Impression - Improvement, to evaluate the time to reaching maintenance dose of pramipexole


Eligibility criteria: Inclusion Criteria:

* Primary Restless Legs Syndrome (i.e. idiopathic RLS)
* Indication for treatment with pramipexole
* Male or female patients older than 18 years

Exclusion Criteria:

* Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients
* Current treatment with pramipexole

Primary outcomes:
measure: Frequency Analysis for Baseline Pattern of RLS Symptoms
timeFrame: Baseline
measure: Change in Total Scores of IRLS (International Restless Legs Rating Scale)
timeFrame: Baseline and final visit (week12)
measure: Change in Global Clinical Impression - Improvement (CGI-I) Scale
timeFrame: baseline and final visit (week 12)
measure: Frequency of Adverse Events
timeFrame: Up to 16 weeks
measure: Correlation of the Change in IRLS at End of Titration and at Final Visit
timeFrame: Up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Absam
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Absdorf
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Afritz
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Alkoven
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Altenmarkt/Zauchensee
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Anif
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Au
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Bad Goisern
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Bad Schallerbach
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Bad Vöslau
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Baden
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Bleiburg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Bludenz
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Bregenz
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Bruck a.d. Mur
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Bärnbach
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Deutschkreutz
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Deutschlandsberg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Dornbirn
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Ebensee
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Faak am See
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Ferlach
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Fieberbrunn
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Filzmoos
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Fischamend
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Fonsdorf
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Fritzens
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Gallizien
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Gallspach
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Gaspoldshofen
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Gerasdorf
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Gloggnitz
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Gmunden
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Grafenstein
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Graz
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Groß Klein
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Grünbach
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Haid
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Halbturn
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Hall in Tirol
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Hart
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Heidenreichstein
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Hornstein
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Innsbruck
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Jenbach
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Judenburg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Kapfenberg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Kematen
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Klagenfurt
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Kleinzell
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Klosterneuburg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Krems
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Kufstein
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Laakirchen
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Langenwang
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Lavamünd
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Leibnitz
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Leoben
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Leopoldsdorf
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Linz
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Litschau
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Litzelsdorf
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Lofer
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Längenfeld
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Marbach
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Mattersburg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Meiningen
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Melk
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Micheldorf
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Michelhausen
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Mödling
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Münzbach
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Neufelden
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Neunkirchen
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Ottenheim
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Pabneukirchen
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Parndorf
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Passail
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Pernegg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Pinggau
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Pischelsdorf
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Poysdorf
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Reichental
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Ried im Innkreis
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Roppen
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Rüstorf
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Salzburg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Sandl
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Sankt Florian
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Sankt Gertraud
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Sankt Pölten
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Satteins
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Schattendorf
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Schwaz
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Schwechat
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Schörfling
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Soielberg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Spielberg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: St. Andrä
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: St. Peter
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: St. Valentin
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: St. Veit an der Glan
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Steinbrunn
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Stockerau
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Strallegg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Telfs
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Veitsch
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Villach
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Vorchdorf
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Völs
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Wagna
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Walding
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Wals
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Wartberg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Wattens
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Weer
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Weiz
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Weißkirchen
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Wels
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Wiener Neudorf
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Wieselburg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Wilhelmsburg
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Windhaag
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Wolkersdorf
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Wr. Neustadt
country: Austria
facility: Boehringer Ingelheim Investigational Site
city: Zirl
country: Austria
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: