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

Completed

Conditions

Restless Legs Syndrome

Study Type

Observational

Enrollment (Actual)

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
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  - Aham, Germany
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  - Ahaus, Germany
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  - Ahlen, Germany
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  - Ahorntal, Germany
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  - Aichach, Germany
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  - Aislingen, Germany
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  - Albstadt, Germany
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  - Aldenhoven, Germany
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  - Aldingen, Germany
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  - Alfeld, Germany
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  - Alpirsbach, Germany
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  - Alsdorf, Germany
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  - Altena, Germany
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  - Altenstadt, Germany
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  - Altomünster, Germany
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  - Alveslohe, Germany
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  - Amberg, Germany
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  - Ammerbuch, Germany
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  - Andernach, Germany
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  - Anklam, Germany
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  - Apolda, Germany
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  - Armsheim, Germany
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  - Arzberg, Germany
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  - Aschaffenburg, Germany
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  - Aschersleben, Germany
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  - Aschheim, Germany
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  - Attendorn, Germany
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  - Auerbach, Germany
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  - Augsburg, Germany
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  - Aurich, Germany
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  - Babensham, Germany
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  - Backnang, Germany
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  - 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
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  - Baltmannsweiler, Germany
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  - Bamberg, Germany
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  - Barleben, Germany
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  - Baunatal, Germany
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  - Bautzen, Germany
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  - Bayreuth, Germany
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  - Beckum, Germany
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  - Beeskow, Germany
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  - Bellheim, Germany
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  - Belm, Germany
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  - Bensheim, Germany
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  - Berching, Germany
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  - Bergfelde, Germany
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  - Bergheim, Germany
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  - Bergisch Gladbach, Germany
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  - Berkheim, Germany
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  - Berlin, Germany
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  - Berne, Germany
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  - Bernsdorf, Germany
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  - Betzdorf, Germany
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  - Biebertal, Germany
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  - Bielefeld, Germany
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  - Bienenbüttel, Germany
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  - Bippen, Germany
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  - Birkenfeld, Germany
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  - Birkenwerder, Germany
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  - Blankenhain, Germany
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  - Blaustein, Germany
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  - Blieskastel, Germany
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  - Bobritzsch, Germany
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  - Bocholt, Germany
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  - Bochum, Germany
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  - Bockenem, Germany
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  - Bodelshausen, Germany
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  - Bodenfelde, Germany
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  - Bodenkirchen, Germany
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  - Bodenwöhr, Germany
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  - Bodman-Ludwigshafen, Germany
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  - Bollendorf, Germany
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  - Bonn, Germany
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  - Bopfingen, Germany
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  - Borgholzhausen, Germany
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  - Borken, Germany
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  - Borna, Germany
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  - Bornheim, Germany
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  - Bottendorf, Germany
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  - Bottmersdorf, Germany
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  - Bottrop, Germany
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  - Bovenden, Germany
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  - Brake, Germany
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  - Brandenburg, Germany
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  - Brannenburg, Germany
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  - Braunschweig, Germany
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  - Brechen, Germany
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  - Breitenbrunn, Germany
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  - Bremen, Germany
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  - Bremerhaven, Germany
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  - Brensbach, Germany
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  - Breuberg, Germany
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  - Bruchköbel, Germany
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  - Brunsbüttel, Germany
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  - Buchbach, Germany
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  - Buckow, Germany
    - Boehringer Ingelheim Investigational Site
  - Bunde, Germany
    - Boehringer Ingelheim Investigational Site
  - Burg, Germany
    - Boehringer Ingelheim Investigational Site
  - Burgau, Germany
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  - Burgdorf, Germany
    - Boehringer Ingelheim Investigational Site
  - Burgpreppach, Germany
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  - Burtenbach, Germany
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  - Buttstädt, Germany
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  - Butzbach, Germany
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  - Bärnau, Germany
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  - Böhlen, Germany
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  - Bösel, Germany
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  - Bückeburg, Germany
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  - 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
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  - Chemnitz, Germany
    - Boehringer Ingelheim Investigational Site
  - Cochem, Germany
    - Boehringer Ingelheim Investigational Site
  - Coppenbrügge, Germany
    - Boehringer Ingelheim Investigational Site
  - Crimmitschau, Germany
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  - 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
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  - Datteln, Germany
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  - Daun, Germany
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  - Deggendorf, Germany
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  - Deidesheim, Germany
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  - Deining, Germany
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  - Delitzsch, Germany
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  - Demen, Germany
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  - Denkendorf, Germany
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  - Dessau, Germany
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  - Detmold, Germany
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  - Dettenheim, Germany
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  - Deuben, Germany
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  - Deutzen, Germany
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  - Diepholz, Germany
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  - Dillingen, Germany
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  - Dingolfing, Germany
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  - Dinkelsbühl, Germany
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  - Dinslaken, Germany
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  - Dissen, Germany
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  - 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
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  - Dummerstorf, Germany
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  - Dörentrup, Germany
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  - Dörpen, Germany
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  - Düren, Germany
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  - Düsseldorf, Germany
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  - Ebergötzen, Germany
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  - Ebermannstadt, Germany
    - Boehringer Ingelheim Investigational Site
  - Eberstadt, Germany
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  - Ebhausen, Germany
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  - Edewecht, Germany
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  - 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
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  - Emmendingen, Germany
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  - Emsdetten, Germany
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  - Enger, Germany
    - Boehringer Ingelheim Investigational Site
  - Enkenbach-Alsenborn, Germany
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  - Ennepetal, Germany
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  - Ennigerloh, Germany
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  - Eppstein, Germany
    - Boehringer Ingelheim Investigational Site
  - Erding, Germany
    - Boehringer Ingelheim Investigational Site
  - Erftstadt, Germany
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  - Erkrath, Germany
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  - Erligheim, Germany
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  - Erndtebrück, Germany
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  - Erolzheim, Germany
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  - Eschborn, Germany
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  - Eschelbronn, Germany
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  - Eschweiler, Germany
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  - Eslohe, Germany
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  - Espenhain, Germany
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  - Essen, Germany
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  - Esslingen, Germany
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  - Euskirchen, Germany
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  - Filderstadt, Germany
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  - Floh-Seligenthal, Germany
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  - Flöha, Germany
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  - Forbach, Germany
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  - Forchheim, Germany
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  - Frankenberg, Germany
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  - Frankenthal, Germany
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  - Frankfurt, Germany
    - Boehringer Ingelheim Investigational Site
  - Freiberg, Germany
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  - Freiburg, Germany
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  - Freigericht, Germany
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  - Freudenstadt, Germany
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  - Freyung, Germany
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  - Friedland, Germany
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  - Friedrichshafen, Germany
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  - Friedrichsthal, Germany
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  - Frohburg, Germany
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  - Fulda, Germany
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  - Furtwangen, Germany
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  - Fürstenwalde, Germany
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  - Füssen, Germany
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  - Gangelt, Germany
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  - Gardelegen, Germany
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  - Garmisch-Partenkirchen, Germany
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  - Gars, Germany
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  - Gaußig, Germany
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  - Gebesee, Germany
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  - Geesthacht, Germany
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  - Gelbensande, Germany
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  - Gelsenkirchen, Germany
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  - Gensingen, Germany
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  - Georgsmarienhütte, Germany
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  - Gera, Germany
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  - Gerbstedt, Germany
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  - Germaringen, Germany
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  - Germering, Germany
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  - Germersheim, Germany
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  - Gevelsberg, Germany
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  - Gießen, Germany
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  - Gifhorn, Germany
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  - Gilserberg, Germany
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  - Gladbeck, Germany
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  - Gleichen, Germany
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  - Goch, Germany
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  - Gochsheim, Germany
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  - Gomaringen, Germany
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  - Grafenau, Germany
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  - Gransee, Germany
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  - Grassau, Germany
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  - Greiz, Germany
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  - Greven, Germany
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  - Grevesmühlen, Germany
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  - Griesheim, Germany
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  - Gronau, Germany
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  - Groß Grönau, Germany
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  - Groß Quenstedt, Germany
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  - Groß-Zimmern, Germany
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  - Großalmerode, Germany
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  - Großbottwar, Germany
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  - Großefehn, Germany
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  - Großhabersdorf, Germany
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  - Großkorbetha, Germany
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  - Großlangheim, Germany
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  - Grömitz, Germany
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  - Grünbach, Germany
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  - Gummersbach, Germany
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  - Göllheim, Germany
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  - Göllingen, Germany
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  - Göttingen, Germany
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  - Güstrow, Germany
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  - Haag, Germany
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  - Hagen, Germany
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  - Haigerloch, Germany
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  - Haldensleben, Germany
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  - Halle, Germany
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  - Hamburg, Germany
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  - Hamm, Germany
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  - Hamminkeln, Germany
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  - Hanau, Germany
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  - Hanerau-Hademarschen, Germany
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  - Hannover, Germany
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  - Harpstedt, Germany
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  - Harsefeld, Germany
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  - Harsewinkel, Germany
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  - 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
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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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

RLS patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients.
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

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

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

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

Related Info

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

February 1, 2007

Primary Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

September 28, 2007

First Submitted That Met QC Criteria

October 2, 2007

First Posted (Estimate)

October 4, 2007

Study Record Updates

Last Update Posted (Estimate)

November 1, 2013

Last Update Submitted That Met QC Criteria

October 31, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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Recruiting

Novel Calcium Channel Modulators in RLS and Variants: Efficacy & Safety

Restless Leg Syndrome (RLS) | Variant Restless Legs Syndrome

China
Wenxia Jiang

Not yet recruiting

Study on the Mechanism of Gut Microbiota Mediating Restless Legs Syndrome Through Iron Metabolism

Restless Legs Syndrome (RLS)
Pamukkale University

Completed

Effectiveness of Matrix Rhythm Therapy for Restless Legs Syndrome (MRT-RLS)

Restless Legs Syndrome (RLS)

Turkey (Türkiye)
Walter Reed National Military Medical Center

Withdrawn

Vasculaire Leg Compression Device for the Treatment of Restless Legs Syndrome - A Prospective Clinical Study

Ekbom Syndrome | Restless Legs Syndrome, | Restless Legs,

United States
GlaxoSmithKline

Completed

Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome)

Restless Legs Syndrome | Restless Legs Syndrome (RLS)

United States
Otsuka Pharmaceutical Co., Ltd.

Completed

A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome (RLS)

Idiopathic Restless Legs Syndrome
Clinica ARS Medica

Not yet recruiting

Study on the Efficacy of Spinal Cord Stimulation in Patients With Severe Refractory Primary or Secondary RLS (REST-SCS)

Restless Leg Syndrome (RLS)

Switzerland
Pfizer's Upjohn has merged with Mylan to form Viatris...

Completed

Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients (RLS)

Idiopathic Restless Legs Syndrome

United States, Spain, Finland, Italy, Germany, Sweden, Austria, Netherlands, United Kingdom
American Regent, Inc.

Completed

Intravenous (IV) Iron Preparation (VIT-45) in the Treatment of Restless Legs Syndrome (RLS)

Restless Legs Syndrome (RLS)
Seton Healthcare Family

Completed

Efficacy of Tyrosine in Restless Legs Syndrome

Restless Legs Syndrome (RLS)

United States

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

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

Study Overview

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