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Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome

NCT ID: NCT00721279

Last Updated: 2014-06-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

549 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Brief Summary

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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

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Detailed Description

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Conditions

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Restless Legs Syndrome

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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Sifrol® (pramipexole dihydrochloride)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Boehringer Ingelheim Investigational Site

Absam, , Austria

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Boehringer Ingelheim Investigational Site

Absdorf, , Austria

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Boehringer Ingelheim Investigational Site

Afritz, , Austria

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Boehringer Ingelheim Investigational Site

Alkoven, , Austria

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Boehringer Ingelheim Investigational Site

Altenmarkt/Zauchensee, , Austria

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Boehringer Ingelheim Investigational Site

Anif, , Austria

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Boehringer Ingelheim Investigational Site

Au, , Austria

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Bad Goisern am Hallstättersee, , Austria

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Boehringer Ingelheim Investigational Site

Bad Schallerbach, , Austria

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Bad Vöslau, , Austria

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Baden, , Austria

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Bärnbach, , Austria

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Bleiburg, , Austria

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Bludenz, , Austria

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Bregenz, , Austria

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Bruck A.d. Mur, , Austria

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Deutschkreutz, , Austria

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Deutschlandsberg, , Austria

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Dornbirn, , Austria

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Ebensee, , Austria

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Faak am See, , Austria

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Ferlach, , Austria

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Fieberbrunn, , Austria

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Filzmoos, , Austria

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Fischamend, , Austria

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Fohnsdorf, , Austria

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Fritzens, , Austria

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Gallizien, , Austria

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Gallspach, , Austria

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Gaspoldshofen, , Austria

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Gerasdorf bei Wien, , Austria

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Gloggnitz, , Austria

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Gmunden, , Austria

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Grafenstein, , Austria

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Graz, , Austria

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Großklein, , Austria

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Grünbach, , Austria

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Haid, , Austria

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Halbturn, , Austria

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Hall in Tirol, , Austria

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Hart, , Austria

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Heidenreichstein, , Austria

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Hornstein, , Austria

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Innsbruck, , Austria

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Jenbach, , Austria

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Judenburg, , Austria

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Kapfenberg, , Austria

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Kematen, , Austria

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Klagenfurt, , Austria

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Kleinzell, , Austria

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Klosterneuburg, , Austria

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Krems, , Austria

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Kufstein, , Austria

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Laakirchen, , Austria

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Langenwang, , Austria

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Lavamünd, , Austria

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Längenfeld, , Austria

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Leibnitz, Styria, , Austria

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Leoben, , Austria

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Leopoldsdorf, , Austria

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Linz, , Austria

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Litschau, , Austria

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Litzelsdorf, , Austria

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Lofer, , Austria

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Marbach, , Austria

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Mattersburg, , Austria

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Meiningen, , Austria

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Melk, , Austria

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Micheldorf, , Austria

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Michelhausen, , Austria

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Mödling, , Austria

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Münzbach, , Austria

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Neufelden, , Austria

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Neunkirchen, , Austria

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Ottenheim, , Austria

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Pabneukirchen, , Austria

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Parndorf, , Austria

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Passail, , Austria

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Pernegg, , Austria

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Pinggau, , Austria

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Pischelsdorf, , Austria

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Poysdorf, , Austria

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Reichental, , Austria

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Ried im Innkreis, , Austria

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Roppen, , Austria

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Rüstorf, , Austria

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Saint Andrä, , Austria

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Saint Peter, , Austria

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Salzburg, , Austria

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Sandl, , Austria

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Sankt Florian, , Austria

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Sankt Gertraud, , Austria

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Sankt Pölten, , Austria

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Sankt Valentin, , Austria

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Sankt Veit an der Glan, , Austria

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Satteins, , Austria

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Schattendorf, , Austria

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Schörfling, , Austria

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Schwaz, , Austria

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Schwechat, , Austria

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Soielberg, , Austria

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Spielberg, , Austria

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Steinbrunn, , Austria

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Stockerau, , Austria

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Strallegg, , Austria

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Telfs, , Austria

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Veitsch, , Austria

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Vienna, , Austria

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Villach, , Austria

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Vorchdorf, , Austria

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Völs, , Austria

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Wagna, , Austria

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Walding, , Austria

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Wals, , Austria

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Wartberg, , Austria

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Wattens, , Austria

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Weer, , Austria

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Weiz, , Austria

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Weißkirchen in Steiermark, , Austria

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Wels, , Austria

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Wiener Neudorf, , Austria

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Wiener Neustadt, , Austria

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Boehringer Ingelheim Investigational Site

Wieselburg, , Austria

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Wilhelmsburg, , Austria

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Windhaag, , Austria

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Boehringer Ingelheim Investigational Site

Wolkersdorf, , Austria

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Boehringer Ingelheim Investigational Site

Zirl, , Austria

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Countries

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Austria

Other Identifiers

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248.655

Identifier Type: -

Identifier Source: org_study_id

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