Non-interventional Observational Study of Pramipexole in Restless Legs Syndrome: Impact on Quality of Life

October 31, 2013 updated by: Boehringer Ingelheim

Sifrol® (Pramipexole) Impact on RLS Related Quality of Life: A 12-weeks Observational Study in Patients With Primary RLS

In this German non-interventional observational study 1980 patients diagnosed with Restless Legs Syndrome (RLS) will be investigated by 990 General Practitioners across all federal states in Germany. Both moderate to severe RLS patients, with or without previous RLS treatment, suffering from RLS symptoms like a desire to move the extremities usually associated with some discomfort, motor restlessness and worsening of symptoms at rest with at least temporary relief by activity, worsening of symptoms later in the day or at night, are eligible for this study, if it is planned to initiate therapy with pramipexole or to add pramipexole to a previously given, insufficient therapy. Three visits are planned to be documented in this PMS study, one baseline visit, visit two after the end of pramipexole titration and visit three after 12 weeks of treatment. Evaluations and visits are to be carried out and documented only if part of routine medical practice. The main goal of observational studies is to determine how pramipexole treatment works when applied in actual practice and thus maximise external validity. In actual practice patients who have been excluded in the clinical registration trials of PPX in moderate to severe primary RLS (i.e. those with certain disease histories, co-morbidities and/or demographic characteristics) will be treated with PPX. Thus in addition during this observational study information on the efficacy and safety of PPX in those patients will be obtained. The objectives of this PMS study are:

  • To evaluate the treatment effect of pramipexole on RLS severity and general improvement as measured by IRLS and CGI-I.
  • To evaluate quality of life of RLS patients as measured by the Restless Legs Syndrome Quality of Life questionnaire (RLS-QoL).
  • To evaluate the safety profile of PPX in a natural study population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2023

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aalen, Germany
        • Boehringer Ingelheim Investigational Site
      • Aarbergen, Germany
        • Boehringer Ingelheim Investigational Site
      • Adendorf, Germany
        • Boehringer Ingelheim Investigational Site
      • Aham, Germany
        • Boehringer Ingelheim Investigational Site
      • Ahaus, Germany
        • Boehringer Ingelheim Investigational Site
      • Ahlen, Germany
        • Boehringer Ingelheim Investigational Site
      • Ahorntal, Germany
        • Boehringer Ingelheim Investigational Site
      • Aichach, Germany
        • Boehringer Ingelheim Investigational Site
      • Aislingen, Germany
        • Boehringer Ingelheim Investigational Site
      • Albstadt, Germany
        • Boehringer Ingelheim Investigational Site
      • Aldenhoven, Germany
        • Boehringer Ingelheim Investigational Site
      • Aldingen, Germany
        • Boehringer Ingelheim Investigational Site
      • Alfeld, Germany
        • Boehringer Ingelheim Investigational Site
      • Alpirsbach, Germany
        • Boehringer Ingelheim Investigational Site
      • Alsdorf, Germany
        • Boehringer Ingelheim Investigational Site
      • Altena, Germany
        • Boehringer Ingelheim Investigational Site
      • Altenstadt, Germany
        • Boehringer Ingelheim Investigational Site
      • Altomünster, Germany
        • Boehringer Ingelheim Investigational Site
      • Alveslohe, Germany
        • Boehringer Ingelheim Investigational Site
      • Amberg, Germany
        • Boehringer Ingelheim Investigational Site
      • Ammerbuch, Germany
        • Boehringer Ingelheim Investigational Site
      • Andernach, Germany
        • Boehringer Ingelheim Investigational Site
      • Anklam, Germany
        • Boehringer Ingelheim Investigational Site
      • Apolda, Germany
        • Boehringer Ingelheim Investigational Site
      • Armsheim, Germany
        • Boehringer Ingelheim Investigational Site
      • Arzberg, Germany
        • Boehringer Ingelheim Investigational Site
      • Aschaffenburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Aschersleben, Germany
        • Boehringer Ingelheim Investigational Site
      • Aschheim, Germany
        • Boehringer Ingelheim Investigational Site
      • Attendorn, Germany
        • Boehringer Ingelheim Investigational Site
      • Auerbach, Germany
        • Boehringer Ingelheim Investigational Site
      • Augsburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Aurich, Germany
        • Boehringer Ingelheim Investigational Site
      • Babensham, Germany
        • Boehringer Ingelheim Investigational Site
      • Backnang, Germany
        • Boehringer Ingelheim Investigational Site
      • Bad Arolsen, Germany
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      • Bad Berleburg, Germany
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      • Bad Bevensen, Germany
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      • Bad Düben, Germany
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      • Bad Dürrenberg, Germany
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      • Bad Dürrheim, Germany
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      • Bad Ems, Germany
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      • Bad Essen, Germany
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      • Bad Kreuznach, Germany
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      • Bad Laasphe, Germany
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      • Bad Langensalza, Germany
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      • Bad Lausick, Germany
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      • Bad Münstereifel, Germany
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      • Bad Oeynhausen, Germany
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      • Bad Salzungen, Germany
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      • Bad Schwalbach, Germany
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      • Bad Schwartau, Germany
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      • Bad Segeberg, Germany
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      • Bad Tennstedt, Germany
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      • Bad Waldsee, Germany
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      • Baden-Baden, Germany
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      • Bahrdorf, Germany
        • Boehringer Ingelheim Investigational Site
      • Baltmannsweiler, Germany
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      • Bamberg, Germany
        • Boehringer Ingelheim Investigational Site
      • Barleben, Germany
        • Boehringer Ingelheim Investigational Site
      • Baunatal, Germany
        • Boehringer Ingelheim Investigational Site
      • Bautzen, Germany
        • Boehringer Ingelheim Investigational Site
      • Bayreuth, Germany
        • Boehringer Ingelheim Investigational Site
      • Beckum, Germany
        • Boehringer Ingelheim Investigational Site
      • Beeskow, Germany
        • Boehringer Ingelheim Investigational Site
      • Bellheim, Germany
        • Boehringer Ingelheim Investigational Site
      • Belm, Germany
        • Boehringer Ingelheim Investigational Site
      • Bensheim, Germany
        • Boehringer Ingelheim Investigational Site
      • Berching, Germany
        • Boehringer Ingelheim Investigational Site
      • Bergfelde, Germany
        • Boehringer Ingelheim Investigational Site
      • Bergheim, Germany
        • Boehringer Ingelheim Investigational Site
      • Bergisch Gladbach, Germany
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      • Berkheim, Germany
        • Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • Boehringer Ingelheim Investigational Site
      • Berne, Germany
        • Boehringer Ingelheim Investigational Site
      • Bernsdorf, Germany
        • Boehringer Ingelheim Investigational Site
      • Betzdorf, Germany
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      • Biebertal, Germany
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      • Bielefeld, Germany
        • Boehringer Ingelheim Investigational Site
      • Bienenbüttel, Germany
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      • Bippen, Germany
        • Boehringer Ingelheim Investigational Site
      • Birkenfeld, Germany
        • Boehringer Ingelheim Investigational Site
      • Birkenwerder, Germany
        • Boehringer Ingelheim Investigational Site
      • Blankenhain, Germany
        • Boehringer Ingelheim Investigational Site
      • Blaustein, Germany
        • Boehringer Ingelheim Investigational Site
      • Blieskastel, Germany
        • Boehringer Ingelheim Investigational Site
      • Bobritzsch, Germany
        • Boehringer Ingelheim Investigational Site
      • Bocholt, Germany
        • Boehringer Ingelheim Investigational Site
      • Bochum, Germany
        • Boehringer Ingelheim Investigational Site
      • Bockenem, Germany
        • Boehringer Ingelheim Investigational Site
      • Bodelshausen, Germany
        • Boehringer Ingelheim Investigational Site
      • Bodenfelde, Germany
        • Boehringer Ingelheim Investigational Site
      • Bodenkirchen, Germany
        • Boehringer Ingelheim Investigational Site
      • Bodenwöhr, Germany
        • Boehringer Ingelheim Investigational Site
      • Bodman-Ludwigshafen, Germany
        • Boehringer Ingelheim Investigational Site
      • Bollendorf, Germany
        • Boehringer Ingelheim Investigational Site
      • Bonn, Germany
        • Boehringer Ingelheim Investigational Site
      • Bopfingen, Germany
        • Boehringer Ingelheim Investigational Site
      • Borgholzhausen, Germany
        • Boehringer Ingelheim Investigational Site
      • Borken, Germany
        • Boehringer Ingelheim Investigational Site
      • Borna, Germany
        • Boehringer Ingelheim Investigational Site
      • Bornheim, Germany
        • Boehringer Ingelheim Investigational Site
      • Bottendorf, Germany
        • Boehringer Ingelheim Investigational Site
      • Bottmersdorf, Germany
        • Boehringer Ingelheim Investigational Site
      • Bottrop, Germany
        • Boehringer Ingelheim Investigational Site
      • Bovenden, Germany
        • Boehringer Ingelheim Investigational Site
      • Brake, Germany
        • Boehringer Ingelheim Investigational Site
      • Brandenburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Brannenburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Braunschweig, Germany
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      • Brechen, Germany
        • Boehringer Ingelheim Investigational Site
      • Breitenbrunn, Germany
        • Boehringer Ingelheim Investigational Site
      • Bremen, Germany
        • Boehringer Ingelheim Investigational Site
      • Bremerhaven, Germany
        • Boehringer Ingelheim Investigational Site
      • Brensbach, Germany
        • Boehringer Ingelheim Investigational Site
      • Breuberg, Germany
        • Boehringer Ingelheim Investigational Site
      • Bruchköbel, Germany
        • Boehringer Ingelheim Investigational Site
      • Brunsbüttel, Germany
        • Boehringer Ingelheim Investigational Site
      • Buchbach, Germany
        • Boehringer Ingelheim Investigational Site
      • Buckow, Germany
        • Boehringer Ingelheim Investigational Site
      • Bunde, Germany
        • Boehringer Ingelheim Investigational Site
      • Burg, Germany
        • Boehringer Ingelheim Investigational Site
      • Burgau, Germany
        • Boehringer Ingelheim Investigational Site
      • Burgdorf, Germany
        • Boehringer Ingelheim Investigational Site
      • Burgpreppach, Germany
        • Boehringer Ingelheim Investigational Site
      • Burtenbach, Germany
        • Boehringer Ingelheim Investigational Site
      • Buttstädt, Germany
        • Boehringer Ingelheim Investigational Site
      • Butzbach, Germany
        • Boehringer Ingelheim Investigational Site
      • Bärnau, Germany
        • Boehringer Ingelheim Investigational Site
      • Böhlen, Germany
        • Boehringer Ingelheim Investigational Site
      • Bösel, Germany
        • Boehringer Ingelheim Investigational Site
      • Bückeburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Büdelsdorf, Germany
        • Boehringer Ingelheim Investigational Site
      • Büttelborn, Germany
        • Boehringer Ingelheim Investigational Site
      • Cadolzburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Calbe, Germany
        • Boehringer Ingelheim Investigational Site
      • Calberlah, Germany
        • Boehringer Ingelheim Investigational Site
      • Castrop-Rauxel, Germany
        • Boehringer Ingelheim Investigational Site
      • Celle, Germany
        • Boehringer Ingelheim Investigational Site
      • Chemnitz, Germany
        • Boehringer Ingelheim Investigational Site
      • Cochem, Germany
        • Boehringer Ingelheim Investigational Site
      • Coppenbrügge, Germany
        • Boehringer Ingelheim Investigational Site
      • Crimmitschau, Germany
        • Boehringer Ingelheim Investigational Site
      • Crivitz, Germany
        • Boehringer Ingelheim Investigational Site
      • Cuxhaven, Germany
        • Boehringer Ingelheim Investigational Site
      • Dabel, Germany
        • Boehringer Ingelheim Investigational Site
      • Darmstadt, Germany
        • Boehringer Ingelheim Investigational Site
      • Dassow, Germany
        • Boehringer Ingelheim Investigational Site
      • Datteln, Germany
        • Boehringer Ingelheim Investigational Site
      • Daun, Germany
        • Boehringer Ingelheim Investigational Site
      • Deggendorf, Germany
        • Boehringer Ingelheim Investigational Site
      • Deidesheim, Germany
        • Boehringer Ingelheim Investigational Site
      • Deining, Germany
        • Boehringer Ingelheim Investigational Site
      • Delitzsch, Germany
        • Boehringer Ingelheim Investigational Site
      • Demen, Germany
        • Boehringer Ingelheim Investigational Site
      • Denkendorf, Germany
        • Boehringer Ingelheim Investigational Site
      • Dessau, Germany
        • Boehringer Ingelheim Investigational Site
      • Detmold, Germany
        • Boehringer Ingelheim Investigational Site
      • Dettenheim, Germany
        • Boehringer Ingelheim Investigational Site
      • Deuben, Germany
        • Boehringer Ingelheim Investigational Site
      • Deutzen, Germany
        • Boehringer Ingelheim Investigational Site
      • Diepholz, Germany
        • Boehringer Ingelheim Investigational Site
      • Dillingen, Germany
        • Boehringer Ingelheim Investigational Site
      • Dingolfing, Germany
        • Boehringer Ingelheim Investigational Site
      • Dinkelsbühl, Germany
        • Boehringer Ingelheim Investigational Site
      • Dinslaken, Germany
        • Boehringer Ingelheim Investigational Site
      • Dissen, Germany
        • Boehringer Ingelheim Investigational Site
      • Dogern, Germany
        • Boehringer Ingelheim Investigational Site
      • Dollern, Germany
        • Boehringer Ingelheim Investigational Site
      • Donaueschingen, Germany
        • Boehringer Ingelheim Investigational Site
      • Dormagen, Germany
        • Boehringer Ingelheim Investigational Site
      • Dornstetten, Germany
        • Boehringer Ingelheim Investigational Site
      • Dorsten, Germany
        • Boehringer Ingelheim Investigational Site
      • Dortmund, Germany
        • Boehringer Ingelheim Investigational Site
      • Dreieich, Germany
        • Boehringer Ingelheim Investigational Site
      • Drensteinfurt, Germany
        • Boehringer Ingelheim Investigational Site
      • Dresden, Germany
        • Boehringer Ingelheim Investigational Site
      • Driedorf, Germany
        • Boehringer Ingelheim Investigational Site
      • Duderstadt, Germany
        • Boehringer Ingelheim Investigational Site
      • Duisburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Dummerstorf, Germany
        • Boehringer Ingelheim Investigational Site
      • Dörentrup, Germany
        • Boehringer Ingelheim Investigational Site
      • Dörpen, Germany
        • Boehringer Ingelheim Investigational Site
      • Düren, Germany
        • Boehringer Ingelheim Investigational Site
      • Düsseldorf, Germany
        • Boehringer Ingelheim Investigational Site
      • Ebergötzen, Germany
        • Boehringer Ingelheim Investigational Site
      • Ebermannstadt, Germany
        • Boehringer Ingelheim Investigational Site
      • Eberstadt, Germany
        • Boehringer Ingelheim Investigational Site
      • Ebhausen, Germany
        • Boehringer Ingelheim Investigational Site
      • Edewecht, Germany
        • Boehringer Ingelheim Investigational Site
      • Edling, Germany
        • Boehringer Ingelheim Investigational Site
      • Egelsbach, Germany
        • Boehringer Ingelheim Investigational Site
      • Ehingen, Germany
        • Boehringer Ingelheim Investigational Site
      • Eilenburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Eisenhüttenstadt, Germany
        • Boehringer Ingelheim Investigational Site
      • Eiterfeld, Germany
        • Boehringer Ingelheim Investigational Site
      • Eitorf, Germany
        • Boehringer Ingelheim Investigational Site
      • Ellwangen, Germany
        • Boehringer Ingelheim Investigational Site
      • Elmshorn, Germany
        • Boehringer Ingelheim Investigational Site
      • Emersacker, Germany
        • Boehringer Ingelheim Investigational Site
      • Emmendingen, Germany
        • Boehringer Ingelheim Investigational Site
      • Emsdetten, Germany
        • Boehringer Ingelheim Investigational Site
      • Enger, Germany
        • Boehringer Ingelheim Investigational Site
      • Enkenbach-Alsenborn, Germany
        • Boehringer Ingelheim Investigational Site
      • Ennepetal, Germany
        • Boehringer Ingelheim Investigational Site
      • Ennigerloh, Germany
        • Boehringer Ingelheim Investigational Site
      • Eppstein, Germany
        • Boehringer Ingelheim Investigational Site
      • Erding, Germany
        • Boehringer Ingelheim Investigational Site
      • Erftstadt, Germany
        • Boehringer Ingelheim Investigational Site
      • Erkrath, Germany
        • Boehringer Ingelheim Investigational Site
      • Erligheim, Germany
        • Boehringer Ingelheim Investigational Site
      • Erndtebrück, Germany
        • Boehringer Ingelheim Investigational Site
      • Erolzheim, Germany
        • Boehringer Ingelheim Investigational Site
      • Eschborn, Germany
        • Boehringer Ingelheim Investigational Site
      • Eschelbronn, Germany
        • Boehringer Ingelheim Investigational Site
      • Eschweiler, Germany
        • Boehringer Ingelheim Investigational Site
      • Eslohe, Germany
        • Boehringer Ingelheim Investigational Site
      • Espenhain, Germany
        • Boehringer Ingelheim Investigational Site
      • Essen, Germany
        • Boehringer Ingelheim Investigational Site
      • Esslingen, Germany
        • Boehringer Ingelheim Investigational Site
      • Euskirchen, Germany
        • Boehringer Ingelheim Investigational Site
      • Filderstadt, Germany
        • Boehringer Ingelheim Investigational Site
      • Floh-Seligenthal, Germany
        • Boehringer Ingelheim Investigational Site
      • Flöha, Germany
        • Boehringer Ingelheim Investigational Site
      • Forbach, Germany
        • Boehringer Ingelheim Investigational Site
      • Forchheim, Germany
        • Boehringer Ingelheim Investigational Site
      • Frankenberg, Germany
        • Boehringer Ingelheim Investigational Site
      • Frankenthal, Germany
        • Boehringer Ingelheim Investigational Site
      • Frankfurt, Germany
        • Boehringer Ingelheim Investigational Site
      • Freiberg, Germany
        • Boehringer Ingelheim Investigational Site
      • Freiburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Freigericht, Germany
        • Boehringer Ingelheim Investigational Site
      • Freudenstadt, Germany
        • Boehringer Ingelheim Investigational Site
      • Freyung, Germany
        • Boehringer Ingelheim Investigational Site
      • Friedland, Germany
        • Boehringer Ingelheim Investigational Site
      • Friedrichshafen, Germany
        • Boehringer Ingelheim Investigational Site
      • Friedrichsthal, Germany
        • Boehringer Ingelheim Investigational Site
      • Frohburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Fulda, Germany
        • Boehringer Ingelheim Investigational Site
      • Furtwangen, Germany
        • Boehringer Ingelheim Investigational Site
      • Fürstenwalde, Germany
        • Boehringer Ingelheim Investigational Site
      • Füssen, Germany
        • Boehringer Ingelheim Investigational Site
      • Gangelt, Germany
        • Boehringer Ingelheim Investigational Site
      • Gardelegen, Germany
        • Boehringer Ingelheim Investigational Site
      • Garmisch-Partenkirchen, Germany
        • Boehringer Ingelheim Investigational Site
      • Gars, Germany
        • Boehringer Ingelheim Investigational Site
      • Gaußig, Germany
        • Boehringer Ingelheim Investigational Site
      • Gebesee, Germany
        • Boehringer Ingelheim Investigational Site
      • Geesthacht, Germany
        • Boehringer Ingelheim Investigational Site
      • Gelbensande, Germany
        • Boehringer Ingelheim Investigational Site
      • Gelsenkirchen, Germany
        • Boehringer Ingelheim Investigational Site
      • Gensingen, Germany
        • Boehringer Ingelheim Investigational Site
      • Georgsmarienhütte, Germany
        • Boehringer Ingelheim Investigational Site
      • Gera, Germany
        • Boehringer Ingelheim Investigational Site
      • Gerbstedt, Germany
        • Boehringer Ingelheim Investigational Site
      • Germaringen, Germany
        • Boehringer Ingelheim Investigational Site
      • Germering, Germany
        • Boehringer Ingelheim Investigational Site
      • Germersheim, Germany
        • Boehringer Ingelheim Investigational Site
      • Gevelsberg, Germany
        • Boehringer Ingelheim Investigational Site
      • Gießen, Germany
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      • Gifhorn, Germany
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      • Gilserberg, Germany
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      • Gladbeck, Germany
        • Boehringer Ingelheim Investigational Site
      • Gleichen, Germany
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      • Goch, Germany
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      • Gochsheim, Germany
        • Boehringer Ingelheim Investigational Site
      • Gomaringen, Germany
        • Boehringer Ingelheim Investigational Site
      • Grafenau, Germany
        • Boehringer Ingelheim Investigational Site
      • Gransee, Germany
        • Boehringer Ingelheim Investigational Site
      • Grassau, Germany
        • Boehringer Ingelheim Investigational Site
      • Greiz, Germany
        • Boehringer Ingelheim Investigational Site
      • Greven, Germany
        • Boehringer Ingelheim Investigational Site
      • Grevesmühlen, Germany
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      • Griesheim, Germany
        • Boehringer Ingelheim Investigational Site
      • Gronau, Germany
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      • Groß Grönau, Germany
        • Boehringer Ingelheim Investigational Site
      • Groß Quenstedt, Germany
        • Boehringer Ingelheim Investigational Site
      • Groß-Zimmern, Germany
        • Boehringer Ingelheim Investigational Site
      • Großalmerode, Germany
        • Boehringer Ingelheim Investigational Site
      • Großbottwar, Germany
        • Boehringer Ingelheim Investigational Site
      • Großefehn, Germany
        • Boehringer Ingelheim Investigational Site
      • Großhabersdorf, Germany
        • Boehringer Ingelheim Investigational Site
      • Großkorbetha, Germany
        • Boehringer Ingelheim Investigational Site
      • Großlangheim, Germany
        • Boehringer Ingelheim Investigational Site
      • Grömitz, Germany
        • Boehringer Ingelheim Investigational Site
      • Grünbach, Germany
        • Boehringer Ingelheim Investigational Site
      • Gummersbach, Germany
        • Boehringer Ingelheim Investigational Site
      • Göllheim, Germany
        • Boehringer Ingelheim Investigational Site
      • Göllingen, Germany
        • Boehringer Ingelheim Investigational Site
      • Göttingen, Germany
        • Boehringer Ingelheim Investigational Site
      • Güstrow, Germany
        • Boehringer Ingelheim Investigational Site
      • Haag, Germany
        • Boehringer Ingelheim Investigational Site
      • Hagen, Germany
        • Boehringer Ingelheim Investigational Site
      • Haigerloch, Germany
        • Boehringer Ingelheim Investigational Site
      • Haldensleben, Germany
        • Boehringer Ingelheim Investigational Site
      • Halle, Germany
        • Boehringer Ingelheim Investigational Site
      • Hamburg, Germany
        • Boehringer Ingelheim Investigational Site
      • Hamm, Germany
        • Boehringer Ingelheim Investigational Site
      • Hamminkeln, Germany
        • Boehringer Ingelheim Investigational Site
      • Hanau, Germany
        • Boehringer Ingelheim Investigational Site
      • Hanerau-Hademarschen, Germany
        • Boehringer Ingelheim Investigational Site
      • Hannover, Germany
        • Boehringer Ingelheim Investigational Site
      • Harpstedt, Germany
        • Boehringer Ingelheim Investigational Site
      • Harsefeld, Germany
        • Boehringer Ingelheim Investigational Site
      • Harsewinkel, Germany
        • Boehringer Ingelheim Investigational Site
      • Haselünne, Germany
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      • Hattersheim, Germany
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      • Hattingen, Germany
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      • Havixbeck, Germany
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      • Hedersleben, Germany
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      • Heek, Germany
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      • Heide, Germany
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      • Heidelberg, Germany
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      • Heilbronn, Germany
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      • Heimsheim, Germany
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      • Heinsberg, Germany
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      • Hellenthal, Germany
        • Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

RLS patients

Description

Inclusion Criteria:

  1. Diagnosis of primary RLS
  2. Indication for RLS treatment with Sifrol® (pramipexole)
  3. Male or female patients aged at least 18 years.

Exclusion Criteria:

  1. Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients.
  2. Ongoing treatment with Sifrol® (pramipexole).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in IRLS total score after 12 weeks
Time Frame: 12 weeks
12 weeks
CGI-I responder rate after 12 weeks
Time Frame: 12 weeks
12 weeks
Time to reach maintenance dose
Time Frame: 12 weeks
12 weeks
Change from baseline in RLS-QoL total score after 12 weeks
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline in IRLS score after 1-4 weeks
Time Frame: 4 weeks
4 weeks
Change in IRLS items after 12 weeks
Time Frame: 12 weeks
12 weeks
Final dose distribution
Time Frame: 12 weeks
12 weeks
Incidence, relationship and seriousness of adverse events
Time Frame: 12 weeks
12 weeks
Number of premature discontinuations
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 248.638

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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