Non-interventional Observational Study With Pramipexole: Impact on Non-motor Symptoms in Parkinson's Disease

October 31, 2013 updated by: Boehringer Ingelheim

Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment

  • To compare the effect of pramipexole on depressive symptoms in early and advanced PD patients
  • To evaluate the course of depressive symptoms measured with UPDRS Part I (mentation, behavior and mood) and with HADS-D under pramipexole treatment
  • To investigate whether improvement of depressive symptoms is linked to improvement in motor function (UPDRS Part III)

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.

Detailed Description

Study Design:

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.
1192

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
      • Aarbergen, Germany
        • Boehringer Ingelheim
      • Adendorf, Germany
        • Boehringer Ingelheim
      • Aham, Germany
        • Boehringer Ingelheim
      • Ahaus, Germany
        • Boehringer Ingelheim
      • Ahlen, Germany
        • Boehringer Ingelheim
      • Ahorntal, Germany
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      • Aichach, Germany
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      • Aislingen, Germany
        • Boehringer Ingelheim
      • Albstadt, Germany
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      • Aldenhoven, Germany
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      • Aldingen, Germany
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      • Alfeld, Germany
        • Boehringer Ingelheim
      • Alpirsbach, Germany
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      • Alsdorf, Germany
        • Boehringer Ingelheim
      • Altena, Germany
        • Boehringer Ingelheim
      • Altenstadt, Germany
        • Boehringer Ingelheim
      • Altomünster, Germany
        • Boehringer Ingelheim
      • Alveslohe, Germany
        • Boehringer Ingelheim
      • 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
        • Boehringer Ingelheim
      • 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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      • 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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      • 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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      • Borken, Germany
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      • Borna, Germany
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      • Bornheim, 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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      • Büttelborn, Germany
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      • Calbe, Germany
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      • Castrop-Rauxel, Germany
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      • Celle, Germany
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      • Chemnitz, Germany
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      • Cochem, Germany
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      • Coppenbrügge, Germany
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      • Crimmitschau, Germany
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      • Crivitz, Germany
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      • Cuxhaven, Germany
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      • Dabel, Germany
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      • Darmstadt, Germany
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      • 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
        • Boehringer Ingelheim
      • Delitzsch, Germany
        • Boehringer Ingelheim
      • 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
        • Boehringer Ingelheim
      • Dingolfing, Germany
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      • Dinkelsbühl, Germany
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      • Dinslaken, Germany
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      • Dissen, Germany
        • Boehringer Ingelheim
      • Dogern, Germany
        • Boehringer Ingelheim
      • Dollern, Germany
        • Boehringer Ingelheim
      • Donaueschingen, Germany
        • Boehringer Ingelheim
      • Dormagen, Germany
        • Boehringer Ingelheim
      • Dornstetten, Germany
        • Boehringer Ingelheim
      • Dorsten, Germany
        • Boehringer Ingelheim
      • Dortmund, Germany
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      • Dreieich, Germany
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      • Drensteinfurt, Germany
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      • Dresden, Germany
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      • Driedorf, Germany
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      • Duderstadt, Germany
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      • 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
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      • Eberstadt, Germany
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      • Ebhausen, Germany
        • Boehringer Ingelheim
      • Edewecht, Germany
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      • Edling, Germany
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      • Egelsbach, Germany
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      • Ehingen, Germany
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      • Eilenburg, Germany
        • Boehringer Ingelheim
      • Eisenhüttenstadt, Germany
        • Boehringer Ingelheim
      • Eiterfeld, Germany
        • Boehringer Ingelheim
      • Eitorf, Germany
        • Boehringer Ingelheim
      • Ellwangen, Germany
        • Boehringer Ingelheim
      • Elmshorn, Germany
        • Boehringer Ingelheim
      • Emersacker, Germany
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      • Emmendingen, Germany
        • Boehringer Ingelheim
      • Emsdetten, Germany
        • Boehringer Ingelheim
      • Enger, Germany
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      • Enkenbach-Alsenborn, Germany
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      • Ennepetal, Germany
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      • Ennigerloh, Germany
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      • Eppstein, Germany
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      • Erding, Germany
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      • Erftstadt, Germany
        • Boehringer Ingelheim
      • Erkrath, Germany
        • Boehringer Ingelheim
      • Erligheim, Germany
        • Boehringer Ingelheim
      • Erndtebrück, Germany
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      • Erolzheim, Germany
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      • Eschborn, Germany
        • Boehringer Ingelheim
      • Eschelbronn, Germany
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      • Eschweiler, Germany
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      • Eslohe, Germany
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      • Espenhain, Germany
        • Boehringer Ingelheim
      • Essen, Germany
        • Boehringer Ingelheim
      • Esslingen, Germany
        • Boehringer Ingelheim
      • Euskirchen, Germany
        • Boehringer Ingelheim
      • Filderstadt, Germany
        • Boehringer Ingelheim
      • Floh-Seligenthal, Germany
        • Boehringer Ingelheim
      • Flöha, Germany
        • Boehringer Ingelheim
      • Forbach, Germany
        • Boehringer Ingelheim
      • Forchheim, Germany
        • Boehringer Ingelheim
      • Frankenberg, Germany
        • Boehringer Ingelheim
      • Frankenthal, Germany
        • Boehringer Ingelheim
      • Frankfurt, Germany
        • Boehringer Ingelheim
      • Freiberg, Germany
        • Boehringer Ingelheim
      • Freiburg, Germany
        • Boehringer Ingelheim
      • Freigericht, Germany
        • Boehringer Ingelheim
      • Freudenstadt, Germany
        • Boehringer Ingelheim
      • Freyung, Germany
        • Boehringer Ingelheim
      • Friedland, Germany
        • Boehringer Ingelheim
      • Friedrichshafen, Germany
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      • Friedrichsthal, Germany
        • Boehringer Ingelheim
      • Frohburg, Germany
        • Boehringer Ingelheim
      • Fulda, Germany
        • Boehringer Ingelheim
      • 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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      • 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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      • 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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      • 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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      • 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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      • 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
        • Boehringer Ingelheim
      • Göttingen, Germany
        • Boehringer Ingelheim
      • 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
        • Boehringer Ingelheim

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

PD patients

Description

Inclusion criteria:

  1. Idiopathic Parkinsons disease with or without fluctuations
  2. Indication for treatment with Sifrol®
  3. Male or female patients of age
  4. Presence of at least mild depressive symptoms (as judged by the treating physician)
  5. Ability to reliably complete a self-rating scale (HADS)

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®.

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
Improvement of depressive symptoms (UPDRS item 3, HADS-D) compared to baseline in early and advanced Parkinsons's disease
Time Frame: 9-16 weeks
9-16 weeks
Change in sum scores of UPDRS Part III (motor examination) from baseline and UPDRS Part I (mentation, behavior and mood) from baseline
Time Frame: 9-16 weeks
9-16 weeks
Change in HADS subscores (anxiety and depression) from baseline
Time Frame: 9-16 weeks
9-16 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
Baseline pattern of patient rated symptom list (HADS)
Time Frame: 9-16 weeks
9-16 weeks
Correlation of the change in UPDRS Part I and UPDRS Part III at the final visit
Time Frame: 9-16 weeks
9-16 weeks
Frequency of adverse events
Time Frame: 9-16 weeks
9-16 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.
March 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.
December 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.
  • 248.639

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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