- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00539214
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
Completed
Conditions
Detailed Description
Study Design:
Study Type
Observational
Enrollment (Actual)
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
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Aalen, Germany
- Boehringer Ingelheim
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Aarbergen, Germany
- Boehringer Ingelheim
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Adendorf, Germany
- Boehringer Ingelheim
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Aham, Germany
- Boehringer Ingelheim
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Ahaus, Germany
- Boehringer Ingelheim
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Ahlen, Germany
- Boehringer Ingelheim
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Ahorntal, Germany
- Boehringer Ingelheim
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Aichach, Germany
- Boehringer Ingelheim
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Aislingen, Germany
- Boehringer Ingelheim
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Albstadt, Germany
- Boehringer Ingelheim
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Aldenhoven, Germany
- Boehringer Ingelheim
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Aldingen, Germany
- Boehringer Ingelheim
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Alfeld, Germany
- Boehringer Ingelheim
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Alpirsbach, Germany
- Boehringer Ingelheim
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Alsdorf, Germany
- Boehringer Ingelheim
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Altena, Germany
- Boehringer Ingelheim
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Altenstadt, Germany
- Boehringer Ingelheim
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Altomünster, Germany
- Boehringer Ingelheim
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Alveslohe, Germany
- Boehringer Ingelheim
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Amberg, Germany
- Boehringer Ingelheim
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Ammerbuch, Germany
- Boehringer Ingelheim
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Andernach, Germany
- Boehringer Ingelheim
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Anklam, Germany
- Boehringer Ingelheim
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Apolda, Germany
- Boehringer Ingelheim
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Armsheim, Germany
- Boehringer Ingelheim
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Arzberg, Germany
- Boehringer Ingelheim
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Aschaffenburg, Germany
- Boehringer Ingelheim
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Aschersleben, Germany
- Boehringer Ingelheim
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Aschheim, Germany
- Boehringer Ingelheim
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Attendorn, Germany
- Boehringer Ingelheim
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Auerbach, Germany
- Boehringer Ingelheim
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Augsburg, Germany
- Boehringer Ingelheim
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Aurich, Germany
- Boehringer Ingelheim
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Babensham, Germany
- Boehringer Ingelheim
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Backnang, Germany
- Boehringer Ingelheim
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Bad Arolsen, Germany
- Boehringer Ingelheim
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Bad Berleburg, Germany
- Boehringer Ingelheim
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Bad Bevensen, Germany
- Boehringer Ingelheim
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Bad Düben, Germany
- Boehringer Ingelheim
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Bad Dürrenberg, Germany
- Boehringer Ingelheim
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Bad Dürrheim, Germany
- Boehringer Ingelheim
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Bad Ems, Germany
- Boehringer Ingelheim
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Bad Essen, Germany
- Boehringer Ingelheim
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Bad Kreuznach, Germany
- Boehringer Ingelheim
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Bad Laasphe, Germany
- Boehringer Ingelheim
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Bad Langensalza, Germany
- Boehringer Ingelheim
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Bad Lausick, Germany
- Boehringer Ingelheim
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Bad Münstereifel, Germany
- Boehringer Ingelheim
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Bad Oeynhausen, Germany
- Boehringer Ingelheim
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Bad Salzungen, Germany
- Boehringer Ingelheim
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Bad Schwalbach, Germany
- Boehringer Ingelheim
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Bad Schwartau, Germany
- Boehringer Ingelheim
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Bad Segeberg, Germany
- Boehringer Ingelheim
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Bad Tennstedt, Germany
- Boehringer Ingelheim
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Bad Waldsee, Germany
- Boehringer Ingelheim
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Baden-Baden, Germany
- Boehringer Ingelheim
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Bahrdorf, Germany
- Boehringer Ingelheim
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Baltmannsweiler, Germany
- Boehringer Ingelheim
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Bamberg, Germany
- Boehringer Ingelheim
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Barleben, Germany
- Boehringer Ingelheim
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Baunatal, Germany
- Boehringer Ingelheim
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Bautzen, Germany
- Boehringer Ingelheim
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Bayreuth, Germany
- Boehringer Ingelheim
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Beckum, Germany
- Boehringer Ingelheim
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Beeskow, Germany
- Boehringer Ingelheim
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Bellheim, Germany
- Boehringer Ingelheim
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Belm, Germany
- Boehringer Ingelheim
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Bensheim, Germany
- Boehringer Ingelheim
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Berching, Germany
- Boehringer Ingelheim
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Bergfelde, Germany
- Boehringer Ingelheim
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Bergheim, Germany
- Boehringer Ingelheim
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Bergisch Gladbach, Germany
- Boehringer Ingelheim
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Berkheim, Germany
- Boehringer Ingelheim
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Berlin, Germany
- Boehringer Ingelheim
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Berne, Germany
- Boehringer Ingelheim
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Bernsdorf, Germany
- Boehringer Ingelheim
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Betzdorf, Germany
- Boehringer Ingelheim
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Biebertal, Germany
- Boehringer Ingelheim
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Bielefeld, Germany
- Boehringer Ingelheim
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Bienenbüttel, Germany
- Boehringer Ingelheim
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Bippen, Germany
- Boehringer Ingelheim
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Birkenfeld, Germany
- Boehringer Ingelheim
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Birkenwerder, Germany
- Boehringer Ingelheim
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Blankenhain, Germany
- Boehringer Ingelheim
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Blaustein, Germany
- Boehringer Ingelheim
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Blieskastel, Germany
- Boehringer Ingelheim
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Bobritzsch, Germany
- Boehringer Ingelheim
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Bocholt, Germany
- Boehringer Ingelheim
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Bochum, Germany
- Boehringer Ingelheim
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Bockenem, Germany
- Boehringer Ingelheim
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Bodelshausen, Germany
- Boehringer Ingelheim
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Bodenfelde, Germany
- Boehringer Ingelheim
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Bodenkirchen, Germany
- Boehringer Ingelheim
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Bodenwöhr, Germany
- Boehringer Ingelheim
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Bodman-Ludwigshafen, Germany
- Boehringer Ingelheim
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Bollendorf, Germany
- Boehringer Ingelheim
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Bonn, Germany
- Boehringer Ingelheim
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Bopfingen, Germany
- Boehringer Ingelheim
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Borgholzhausen, Germany
- Boehringer Ingelheim
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Borken, Germany
- Boehringer Ingelheim
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Borna, Germany
- Boehringer Ingelheim
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Bornheim, Germany
- Boehringer Ingelheim
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Bottendorf, Germany
- Boehringer Ingelheim
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Bottmersdorf, Germany
- Boehringer Ingelheim
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Bottrop, Germany
- Boehringer Ingelheim
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Bovenden, Germany
- Boehringer Ingelheim
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Brake, Germany
- Boehringer Ingelheim
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Brandenburg, Germany
- Boehringer Ingelheim
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Brannenburg, Germany
- Boehringer Ingelheim
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Braunschweig, Germany
- Boehringer Ingelheim
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Brechen, Germany
- Boehringer Ingelheim
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Breitenbrunn, Germany
- Boehringer Ingelheim
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Bremen, Germany
- Boehringer Ingelheim
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Bremerhaven, Germany
- Boehringer Ingelheim
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Brensbach, Germany
- Boehringer Ingelheim
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Breuberg, Germany
- Boehringer Ingelheim
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Bruchköbel, Germany
- Boehringer Ingelheim
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Brunsbüttel, Germany
- Boehringer Ingelheim
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Buchbach, Germany
- Boehringer Ingelheim
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Buckow, Germany
- Boehringer Ingelheim
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Bunde, Germany
- Boehringer Ingelheim
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Burg, Germany
- Boehringer Ingelheim
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Burgau, Germany
- Boehringer Ingelheim
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Burgdorf, Germany
- Boehringer Ingelheim
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Burgpreppach, Germany
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Burtenbach, Germany
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Buttstädt, Germany
- Boehringer Ingelheim
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Butzbach, Germany
- Boehringer Ingelheim
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Bärnau, Germany
- Boehringer Ingelheim
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Böhlen, Germany
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Bösel, Germany
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Bückeburg, Germany
- Boehringer Ingelheim
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Büdelsdorf, Germany
- Boehringer Ingelheim
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Büttelborn, Germany
- Boehringer Ingelheim
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Cadolzburg, Germany
- Boehringer Ingelheim
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Calbe, Germany
- Boehringer Ingelheim
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Calberlah, Germany
- Boehringer Ingelheim
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Castrop-Rauxel, Germany
- Boehringer Ingelheim
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Celle, Germany
- Boehringer Ingelheim
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Chemnitz, Germany
- Boehringer Ingelheim
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Cochem, Germany
- Boehringer Ingelheim
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Coppenbrügge, Germany
- Boehringer Ingelheim
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Crimmitschau, Germany
- Boehringer Ingelheim
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Crivitz, Germany
- Boehringer Ingelheim
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Cuxhaven, Germany
- Boehringer Ingelheim
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Dabel, Germany
- Boehringer Ingelheim
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Darmstadt, Germany
- Boehringer Ingelheim
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Dassow, Germany
- Boehringer Ingelheim
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Datteln, Germany
- Boehringer Ingelheim
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Daun, Germany
- Boehringer Ingelheim
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Deggendorf, Germany
- Boehringer Ingelheim
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Deidesheim, Germany
- Boehringer Ingelheim
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Deining, Germany
- Boehringer Ingelheim
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Delitzsch, Germany
- Boehringer Ingelheim
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Demen, Germany
- Boehringer Ingelheim
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Denkendorf, Germany
- Boehringer Ingelheim
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Dessau, Germany
- Boehringer Ingelheim
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Detmold, Germany
- Boehringer Ingelheim
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Dettenheim, Germany
- Boehringer Ingelheim
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Deuben, Germany
- Boehringer Ingelheim
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Deutzen, Germany
- Boehringer Ingelheim
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Diepholz, Germany
- Boehringer Ingelheim
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Dillingen, Germany
- Boehringer Ingelheim
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Dingolfing, Germany
- Boehringer Ingelheim
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Dinkelsbühl, Germany
- Boehringer Ingelheim
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Dinslaken, Germany
- Boehringer Ingelheim
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Dissen, Germany
- Boehringer Ingelheim
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Dogern, Germany
- Boehringer Ingelheim
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Dollern, Germany
- Boehringer Ingelheim
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Donaueschingen, Germany
- Boehringer Ingelheim
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Dormagen, Germany
- Boehringer Ingelheim
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Dornstetten, Germany
- Boehringer Ingelheim
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Dorsten, Germany
- Boehringer Ingelheim
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Dortmund, Germany
- Boehringer Ingelheim
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Dreieich, Germany
- Boehringer Ingelheim
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Drensteinfurt, Germany
- Boehringer Ingelheim
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Dresden, Germany
- Boehringer Ingelheim
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Driedorf, Germany
- Boehringer Ingelheim
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Duderstadt, Germany
- Boehringer Ingelheim
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Duisburg, Germany
- Boehringer Ingelheim
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Dummerstorf, Germany
- Boehringer Ingelheim
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Dörentrup, Germany
- Boehringer Ingelheim
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Dörpen, Germany
- Boehringer Ingelheim
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Düren, Germany
- Boehringer Ingelheim
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Düsseldorf, Germany
- Boehringer Ingelheim
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Ebergötzen, Germany
- Boehringer Ingelheim
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Ebermannstadt, Germany
- Boehringer Ingelheim
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Eberstadt, Germany
- Boehringer Ingelheim
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Ebhausen, Germany
- Boehringer Ingelheim
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Edewecht, Germany
- Boehringer Ingelheim
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Edling, Germany
- Boehringer Ingelheim
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Egelsbach, Germany
- Boehringer Ingelheim
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Ehingen, Germany
- Boehringer Ingelheim
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Eilenburg, Germany
- Boehringer Ingelheim
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Eisenhüttenstadt, Germany
- Boehringer Ingelheim
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Eiterfeld, Germany
- Boehringer Ingelheim
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Eitorf, Germany
- Boehringer Ingelheim
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Ellwangen, Germany
- Boehringer Ingelheim
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Elmshorn, Germany
- Boehringer Ingelheim
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Emersacker, Germany
- Boehringer Ingelheim
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Emmendingen, Germany
- Boehringer Ingelheim
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Emsdetten, Germany
- Boehringer Ingelheim
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Enger, Germany
- Boehringer Ingelheim
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Enkenbach-Alsenborn, Germany
- Boehringer Ingelheim
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Ennepetal, Germany
- Boehringer Ingelheim
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Ennigerloh, Germany
- Boehringer Ingelheim
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Eppstein, Germany
- Boehringer Ingelheim
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Erding, Germany
- Boehringer Ingelheim
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Erftstadt, Germany
- Boehringer Ingelheim
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Erkrath, Germany
- Boehringer Ingelheim
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Erligheim, Germany
- Boehringer Ingelheim
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Erndtebrück, Germany
- Boehringer Ingelheim
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Erolzheim, Germany
- Boehringer Ingelheim
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Eschborn, Germany
- Boehringer Ingelheim
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Eschelbronn, Germany
- Boehringer Ingelheim
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Eschweiler, Germany
- Boehringer Ingelheim
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Eslohe, Germany
- Boehringer Ingelheim
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Espenhain, Germany
- Boehringer Ingelheim
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Essen, Germany
- Boehringer Ingelheim
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Esslingen, Germany
- Boehringer Ingelheim
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Euskirchen, Germany
- Boehringer Ingelheim
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Filderstadt, Germany
- Boehringer Ingelheim
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Floh-Seligenthal, Germany
- Boehringer Ingelheim
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Flöha, Germany
- Boehringer Ingelheim
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Forbach, Germany
- Boehringer Ingelheim
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Forchheim, Germany
- Boehringer Ingelheim
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Frankenberg, Germany
- Boehringer Ingelheim
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Frankenthal, Germany
- Boehringer Ingelheim
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Frankfurt, Germany
- Boehringer Ingelheim
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Freiberg, Germany
- Boehringer Ingelheim
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Freiburg, Germany
- Boehringer Ingelheim
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Freigericht, Germany
- Boehringer Ingelheim
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Freudenstadt, Germany
- Boehringer Ingelheim
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Freyung, Germany
- Boehringer Ingelheim
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Friedland, Germany
- Boehringer Ingelheim
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Friedrichshafen, Germany
- Boehringer Ingelheim
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Friedrichsthal, Germany
- Boehringer Ingelheim
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Frohburg, Germany
- Boehringer Ingelheim
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Fulda, Germany
- Boehringer Ingelheim
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Furtwangen, Germany
- Boehringer Ingelheim
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Fürstenwalde, Germany
- Boehringer Ingelheim
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Füssen, Germany
- Boehringer Ingelheim
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Gangelt, Germany
- Boehringer Ingelheim
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Gardelegen, Germany
- Boehringer Ingelheim
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Garmisch-Partenkirchen, Germany
- Boehringer Ingelheim
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Gars, Germany
- Boehringer Ingelheim
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Gaußig, Germany
- Boehringer Ingelheim
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Gebesee, Germany
- Boehringer Ingelheim
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Geesthacht, Germany
- Boehringer Ingelheim
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Gelbensande, Germany
- Boehringer Ingelheim
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Gelsenkirchen, Germany
- Boehringer Ingelheim
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Gensingen, Germany
- Boehringer Ingelheim
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Georgsmarienhütte, Germany
- Boehringer Ingelheim
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Gera, Germany
- Boehringer Ingelheim
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Gerbstedt, Germany
- Boehringer Ingelheim
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Germaringen, Germany
- Boehringer Ingelheim
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Germering, Germany
- Boehringer Ingelheim
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Germersheim, Germany
- Boehringer Ingelheim
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Gevelsberg, Germany
- Boehringer Ingelheim
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Gießen, Germany
- Boehringer Ingelheim
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Gifhorn, Germany
- Boehringer Ingelheim
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Gilserberg, Germany
- Boehringer Ingelheim
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Gladbeck, Germany
- Boehringer Ingelheim
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Gleichen, Germany
- Boehringer Ingelheim
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Goch, Germany
- Boehringer Ingelheim
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Gochsheim, Germany
- Boehringer Ingelheim
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Gomaringen, Germany
- Boehringer Ingelheim
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Grafenau, Germany
- Boehringer Ingelheim
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Gransee, Germany
- Boehringer Ingelheim
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Grassau, Germany
- Boehringer Ingelheim
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Greiz, Germany
- Boehringer Ingelheim
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Greven, Germany
- Boehringer Ingelheim
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Grevesmühlen, Germany
- Boehringer Ingelheim
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Griesheim, Germany
- Boehringer Ingelheim
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Gronau, Germany
- Boehringer Ingelheim
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Groß Grönau, Germany
- Boehringer Ingelheim
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Groß Quenstedt, Germany
- Boehringer Ingelheim
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Groß-Zimmern, Germany
- Boehringer Ingelheim
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Großalmerode, Germany
- Boehringer Ingelheim
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Großbottwar, Germany
- Boehringer Ingelheim
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Großefehn, Germany
- Boehringer Ingelheim
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Großhabersdorf, Germany
- Boehringer Ingelheim
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Großkorbetha, Germany
- Boehringer Ingelheim
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Großlangheim, Germany
- Boehringer Ingelheim
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Grömitz, Germany
- Boehringer Ingelheim
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Grünbach, Germany
- Boehringer Ingelheim
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Gummersbach, Germany
- Boehringer Ingelheim
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Göllheim, Germany
- Boehringer Ingelheim
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Göllingen, Germany
- Boehringer Ingelheim
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Göttingen, Germany
- Boehringer Ingelheim
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Güstrow, Germany
- Boehringer Ingelheim
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Haag, Germany
- Boehringer Ingelheim
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Hagen, Germany
- Boehringer Ingelheim
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Haigerloch, Germany
- Boehringer Ingelheim
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Haldensleben, Germany
- Boehringer Ingelheim
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Halle, Germany
- Boehringer Ingelheim
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Hamburg, Germany
- Boehringer Ingelheim
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Hamm, Germany
- Boehringer Ingelheim
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Hamminkeln, Germany
- Boehringer Ingelheim
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Hanau, Germany
- Boehringer Ingelheim
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Hanerau-Hademarschen, Germany
- Boehringer Ingelheim
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Hannover, Germany
- Boehringer Ingelheim
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Harpstedt, Germany
- Boehringer Ingelheim
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Harsefeld, Germany
- Boehringer Ingelheim
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Harsewinkel, Germany
- Boehringer Ingelheim
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Haselünne, Germany
- Boehringer Ingelheim
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Hattersheim, Germany
- Boehringer Ingelheim
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Hattingen, Germany
- Boehringer Ingelheim
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Havixbeck, Germany
- Boehringer Ingelheim
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Hedersleben, Germany
- Boehringer Ingelheim
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Heek, Germany
- Boehringer Ingelheim
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Heide, Germany
- Boehringer Ingelheim
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Heidelberg, Germany
- Boehringer Ingelheim
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Heilbronn, Germany
- Boehringer Ingelheim
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Heimsheim, Germany
- Boehringer Ingelheim
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Heinsberg, Germany
- Boehringer Ingelheim
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Hellenthal, Germany
- Boehringer Ingelheim
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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
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
PD patients
Description
Inclusion criteria:
- Idiopathic Parkinsons disease with or without fluctuations
- Indication for treatment with Sifrol®
- Male or female patients of age
- Presence of at least mild depressive symptoms (as judged by the treating physician)
- Ability to reliably complete a self-rating scale (HADS)
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®.
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 |
|---|---|
|
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
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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
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
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
March 1, 2007
Primary Completion (Actual)
December 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
- 248.639
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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