Non-interventional Observational Study With Pramipexole: Impact on Non-motor Symptoms in Parkinson's Disease
Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment
1 other identifier
observational
1,192
1 country
317
Brief Summary
- 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
317 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 28, 2007
CompletedFirst Posted
Study publicly available on registry
October 4, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedNovember 1, 2013
October 1, 2013
9 months
September 28, 2007
October 31, 2013
Conditions
Outcome Measures
Primary Outcomes (3)
Improvement of depressive symptoms (UPDRS item 3, HADS-D) compared to baseline in early and advanced Parkinsons's disease
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
9-16 weeks
Change in HADS subscores (anxiety and depression) from baseline
9-16 weeks
Secondary Outcomes (3)
Baseline pattern of patient rated symptom list (HADS)
9-16 weeks
Correlation of the change in UPDRS Part I and UPDRS Part III at the final visit
9-16 weeks
Frequency of adverse events
9-16 weeks
Eligibility Criteria
PD patients
You may qualify if:
- 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)
You may not qualify if:
- Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients.
- Ongoing treatment with Sifrol®.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (317)
Boehringer Ingelheim
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
Boehringer Ingelheim
Aichach, Germany
Boehringer Ingelheim
Aislingen, Germany
Boehringer Ingelheim
Albstadt, Germany
Boehringer Ingelheim
Aldenhoven, Germany
Boehringer Ingelheim
Aldingen, Germany
Boehringer Ingelheim
Alfeld, Germany
Boehringer Ingelheim
Alpirsbach, Germany
Boehringer Ingelheim
Alsdorf, Germany
Boehringer Ingelheim
Altena, Germany
Boehringer Ingelheim
Altenstadt, Germany
Boehringer Ingelheim
Altomünster, Germany
Boehringer Ingelheim
Alveslohe, Germany
Boehringer Ingelheim
Amberg, Germany
Boehringer Ingelheim
Ammerbuch, Germany
Boehringer Ingelheim
Andernach, Germany
Boehringer Ingelheim
Anklam, Germany
Boehringer Ingelheim
Apolda, Germany
Boehringer Ingelheim
Armsheim, Germany
Boehringer Ingelheim
Arzberg, Germany
Boehringer Ingelheim
Aschaffenburg, Germany
Boehringer Ingelheim
Aschersleben, Germany
Boehringer Ingelheim
Aschheim, Germany
Boehringer Ingelheim
Attendorn, Germany
Boehringer Ingelheim
Auerbach, Germany
Boehringer Ingelheim
Augsburg, Germany
Boehringer Ingelheim
Aurich, Germany
Boehringer Ingelheim
Babensham, Germany
Boehringer Ingelheim
Backnang, Germany
Boehringer Ingelheim
Bad Arolsen, Germany
Boehringer Ingelheim
Bad Berleburg, Germany
Boehringer Ingelheim
Bad Bevensen, Germany
Boehringer Ingelheim
Bad Düben, Germany
Boehringer Ingelheim
Bad Dürrenberg, Germany
Boehringer Ingelheim
Bad Dürrheim, Germany
Boehringer Ingelheim
Bad Ems, Germany
Boehringer Ingelheim
Bad Essen, Germany
Boehringer Ingelheim
Bad Kreuznach, Germany
Boehringer Ingelheim
Bad Laasphe, Germany
Boehringer Ingelheim
Bad Langensalza, Germany
Boehringer Ingelheim
Bad Lausick, Germany
Boehringer Ingelheim
Bad Münstereifel, Germany
Boehringer Ingelheim
Bad Oeynhausen, Germany
Boehringer Ingelheim
Bad Salzungen, Germany
Boehringer Ingelheim
Bad Schwalbach, Germany
Boehringer Ingelheim
Bad Schwartau, Germany
Boehringer Ingelheim
Bad Segeberg, Germany
Boehringer Ingelheim
Bad Tennstedt, Germany
Boehringer Ingelheim
Bad Waldsee, Germany
Boehringer Ingelheim
Baden-Baden, Germany
Boehringer Ingelheim
Bahrdorf, Germany
Boehringer Ingelheim
Baltmannsweiler, Germany
Boehringer Ingelheim
Bamberg, Germany
Boehringer Ingelheim
Barleben, Germany
Boehringer Ingelheim
Baunatal, Germany
Boehringer Ingelheim
Bautzen, Germany
Boehringer Ingelheim
Bayreuth, Germany
Boehringer Ingelheim
Bärnau, Germany
Boehringer Ingelheim
Beckum, Germany
Boehringer Ingelheim
Beeskow, Germany
Boehringer Ingelheim
Bellheim, Germany
Boehringer Ingelheim
Belm, Germany
Boehringer Ingelheim
Bensheim, Germany
Boehringer Ingelheim
Berching, Germany
Boehringer Ingelheim
Bergfelde, Germany
Boehringer Ingelheim
Bergheim, Germany
Boehringer Ingelheim
Bergisch Gladbach, Germany
Boehringer Ingelheim
Berkheim, Germany
Boehringer Ingelheim
Berlin, Germany
Boehringer Ingelheim
Berne, Germany
Boehringer Ingelheim
Bernsdorf, Germany
Boehringer Ingelheim
Betzdorf, Germany
Boehringer Ingelheim
Biebertal, Germany
Boehringer Ingelheim
Bielefeld, Germany
Boehringer Ingelheim
Bienenbüttel, Germany
Boehringer Ingelheim
Bippen, Germany
Boehringer Ingelheim
Birkenfeld, Germany
Boehringer Ingelheim
Birkenwerder, Germany
Boehringer Ingelheim
Blankenhain, Germany
Boehringer Ingelheim
Blaustein, Germany
Boehringer Ingelheim
Blieskastel, Germany
Boehringer Ingelheim
Bobritzsch, Germany
Boehringer Ingelheim
Bocholt, Germany
Boehringer Ingelheim
Bochum, Germany
Boehringer Ingelheim
Bockenem, Germany
Boehringer Ingelheim
Bodelshausen, Germany
Boehringer Ingelheim
Bodenfelde, Germany
Boehringer Ingelheim
Bodenkirchen, Germany
Boehringer Ingelheim
Bodenwöhr, Germany
Boehringer Ingelheim
Bodman-Ludwigshafen, Germany
Boehringer Ingelheim
Bollendorf, Germany
Boehringer Ingelheim
Bonn, Germany
Boehringer Ingelheim
Bopfingen, Germany
Boehringer Ingelheim
Borgholzhausen, Germany
Boehringer Ingelheim
Borken, Germany
Boehringer Ingelheim
Borna, Germany
Boehringer Ingelheim
Bornheim, Germany
Boehringer Ingelheim
Bottendorf, Germany
Boehringer Ingelheim
Bottmersdorf, Germany
Boehringer Ingelheim
Bottrop, Germany
Boehringer Ingelheim
Bovenden, Germany
Boehringer Ingelheim
Böhlen, Germany
Boehringer Ingelheim
Bösel, Germany
Boehringer Ingelheim
Brake, Germany
Boehringer Ingelheim
Brandenburg, Germany
Boehringer Ingelheim
Brannenburg, Germany
Boehringer Ingelheim
Braunschweig, Germany
Boehringer Ingelheim
Brechen, Germany
Boehringer Ingelheim
Breitenbrunn, Germany
Boehringer Ingelheim
Bremen, Germany
Boehringer Ingelheim
Bremerhaven, Germany
Boehringer Ingelheim
Brensbach, Germany
Boehringer Ingelheim
Breuberg, Germany
Boehringer Ingelheim
Bruchköbel, Germany
Boehringer Ingelheim
Brunsbüttel, Germany
Boehringer Ingelheim
Buchbach, Germany
Boehringer Ingelheim
Buckow, Germany
Boehringer Ingelheim
Buedelsdorf, Germany
Boehringer Ingelheim
Burg, Germany
Boehringer Ingelheim
Burgau, Germany
Boehringer Ingelheim
Burgdorf, Hanover, Germany
Boehringer Ingelheim
Burgpreppach, Germany
Boehringer Ingelheim
Burtenbach, Germany
Boehringer Ingelheim
Buttstädt, Germany
Boehringer Ingelheim
Butzbach, Germany
Boehringer Ingelheim
Bückeburg, Germany
Boehringer Ingelheim
Bünde, Germany
Boehringer Ingelheim
Büttelborn, Germany
Boehringer Ingelheim
Cadolzburg, Germany
Boehringer Ingelheim
Calbe, Germany
Boehringer Ingelheim
Calberlah, Germany
Boehringer Ingelheim
Castrop-Rauxel, Germany
Boehringer Ingelheim
Celle, Germany
Boehringer Ingelheim
Chemnitz, Germany
Boehringer Ingelheim
Cochem, Germany
Boehringer Ingelheim
Coppenbrügge, Germany
Boehringer Ingelheim
Crimmitschau, Germany
Boehringer Ingelheim
Crivitz, Germany
Boehringer Ingelheim
Cuxhaven, Germany
Boehringer Ingelheim
Dabel, Germany
Boehringer Ingelheim
Darmstadt, Germany
Boehringer Ingelheim
Dassow, Germany
Boehringer Ingelheim
Datteln, Germany
Boehringer Ingelheim
Daun, Germany
Boehringer Ingelheim
Deggendorf, Germany
Boehringer Ingelheim
Deidesheim, Germany
Boehringer Ingelheim
Deining, Germany
Boehringer Ingelheim
Delitzsch, Germany
Boehringer Ingelheim
Demen, Germany
Boehringer Ingelheim
Denkendorf, Germany
Boehringer Ingelheim
Dessau, Germany
Boehringer Ingelheim
Detmold, Germany
Boehringer Ingelheim
Dettenheim, Germany
Boehringer Ingelheim
Deuben, Germany
Boehringer Ingelheim
Deutzen, Germany
Boehringer Ingelheim
Diepholz, Germany
Boehringer Ingelheim
Dillingen, Germany
Boehringer Ingelheim
Dingolfing, Germany
Boehringer Ingelheim
Dinkelsbühl, Germany
Boehringer Ingelheim
Dinslaken, Germany
Boehringer Ingelheim
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
Boehringer Ingelheim
Dörentrup, Germany
Boehringer Ingelheim
Dörpen, Germany
Boehringer Ingelheim
Dreieich, Germany
Boehringer Ingelheim
Drensteinfurt, Germany
Boehringer Ingelheim
Dresden, Germany
Boehringer Ingelheim
Driedorf, Germany
Boehringer Ingelheim
Duderstadt, Germany
Boehringer Ingelheim
Duisburg, Germany
Boehringer Ingelheim
Dummerstorf, Germany
Boehringer Ingelheim
Düren, Germany
Boehringer Ingelheim
Düsseldorf, Germany
Boehringer Ingelheim
Ebergötzen, Germany
Boehringer Ingelheim
Ebermannstadt, Germany
Boehringer Ingelheim
Eberstadt, Germany
Boehringer Ingelheim
Ebhausen, Germany
Boehringer Ingelheim
Edewecht, Germany
Boehringer Ingelheim
Edling, Germany
Boehringer Ingelheim
Egelsbach, Germany
Boehringer Ingelheim
Ehingen, Germany
Boehringer Ingelheim
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
Boehringer Ingelheim
Emmendingen, Germany
Boehringer Ingelheim
Emsdetten, Germany
Boehringer Ingelheim
Enger, Germany
Boehringer Ingelheim
Enkenbach-Alsenborn, Germany
Boehringer Ingelheim
Ennepetal, Germany
Boehringer Ingelheim
Ennigerloh, Germany
Boehringer Ingelheim
Eppstein, Germany
Boehringer Ingelheim
Erding, Germany
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Erftstadt, Germany
Boehringer Ingelheim
Erkrath, Germany
Boehringer Ingelheim
Erligheim, Germany
Boehringer Ingelheim
Erndtebrück, Germany
Boehringer Ingelheim
Erolzheim, Germany
Boehringer Ingelheim
Eschborn, Germany
Boehringer Ingelheim
Eschelbronn, Germany
Boehringer Ingelheim
Eschweiler, Germany
Boehringer Ingelheim
Eslohe, Germany
Boehringer Ingelheim
Espenhain, Germany
Boehringer Ingelheim
Essen, Germany
Boehringer Ingelheim
Esslingen am Neckar, 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 im Breisgau, Germany
Boehringer Ingelheim
Freigericht, Germany
Boehringer Ingelheim
Freudenstadt, Germany
Boehringer Ingelheim
Freyung, Germany
Boehringer Ingelheim
Friedland, Germany
Boehringer Ingelheim
Friedrichshafen, Germany
Boehringer Ingelheim
Friedrichsthal, Germany
Boehringer Ingelheim
Frohburg, Germany
Boehringer Ingelheim
Fulda, Germany
Boehringer Ingelheim
Furtwangen im Schwarzwald, Germany
Boehringer Ingelheim
Fürstenwalde, Germany
Boehringer Ingelheim
Füssen, Germany
Boehringer Ingelheim
Gangelt, Germany
Boehringer Ingelheim
Gardelegen, Germany
Boehringer Ingelheim
Garmisch-Partenkirchen, Germany
Boehringer Ingelheim
Gars, Germany
Boehringer Ingelheim
Gebesee, Germany
Boehringer Ingelheim
Geesthacht, Germany
Boehringer Ingelheim
Gelbensande, Germany
Boehringer Ingelheim
Gelsenkirchen, Germany
Boehringer Ingelheim
Gensingen, Germany
Boehringer Ingelheim
Georgsmarienhütte, Germany
Boehringer Ingelheim
Gera, Germany
Boehringer Ingelheim
Gerbstedt, Germany
Boehringer Ingelheim
Germering, Germany
Boehringer Ingelheim
Germersheim, Germany
Boehringer Ingelheim
Gevelsberg, Germany
Boehringer Ingelheim
Giessen, Germany
Boehringer Ingelheim
Gifhorn, Germany
Boehringer Ingelheim
Gilserberg, Germany
Boehringer Ingelheim
Gladbeck, Germany
Boehringer Ingelheim
Gleichen, Germany
Boehringer Ingelheim
Goch, Germany
Boehringer Ingelheim
Gochsheim, Germany
Boehringer Ingelheim
Gomaringen, Germany
Boehringer Ingelheim
Göllheim, Germany
Boehringer Ingelheim
Göllingen, Germany
Boehringer Ingelheim
Göttingen, Germany
Boehringer Ingelheim
Grafenau, Germany
Boehringer Ingelheim
Gransee, Germany
Boehringer Ingelheim
Grassau, Germany
Boehringer Ingelheim
Greiz, Germany
Boehringer Ingelheim
Greven, Germany
Boehringer Ingelheim
Grevesmühlen, Germany
Boehringer Ingelheim
Griesheim, Germany
Boehringer Ingelheim
Gronau, Germany
Boehringer Ingelheim
Groß Grönau, Germany
Boehringer Ingelheim
Groß Quenstedt, Germany
Boehringer Ingelheim
Groß-Zimmern, Germany
Boehringer Ingelheim
Großalmerode, Germany
Boehringer Ingelheim
Großbottwar, Germany
Boehringer Ingelheim
Großefehn, Germany
Boehringer Ingelheim
Großhabersdorf, Germany
Boehringer Ingelheim
Großkorbetha, Germany
Boehringer Ingelheim
Großlangheim, Germany
Boehringer Ingelheim
Grömitz, Germany
Boehringer Ingelheim
Grünbach, Germany
Boehringer Ingelheim
Gummersbach, Germany
Boehringer Ingelheim
Güstrow, Germany
Boehringer Ingelheim
Haag, Germany
Boehringer Ingelheim
Hagen, Germany
Boehringer Ingelheim
Haigerloch, Germany
Boehringer Ingelheim
Haldensleben I, Germany
Boehringer Ingelheim
Halle, Germany
Boehringer Ingelheim
Hamburg, Germany
Boehringer Ingelheim
Hamm, Germany
Boehringer Ingelheim
Hamminkeln, Germany
Boehringer Ingelheim
Hanau, Germany
Boehringer Ingelheim
Hanerau-Hademarschen, Germany
Boehringer Ingelheim
Hanover, Germany
Boehringer Ingelheim
Harpstedt, Germany
Boehringer Ingelheim
Harsefeld, Germany
Boehringer Ingelheim
Harsewinkel, Germany
Boehringer Ingelheim
Haselünne, Germany
Boehringer Ingelheim
Hattersheim, Germany
Boehringer Ingelheim
Hattingen, Germany
Boehringer Ingelheim
Havixbeck, Germany
Boehringer Ingelheim
Hedersleben, Germany
Boehringer Ingelheim
Heek, Germany
Boehringer Ingelheim
Heide, Germany
Boehringer Ingelheim
Heidelberg, Germany
Boehringer Ingelheim
Heilbronn, Germany
Boehringer Ingelheim
Heimsheim, Germany
Boehringer Ingelheim
Heinsberg, Germany
Boehringer Ingelheim
Hellenthal, Germany
Boehringer Ingelheim
Hermaringen, Germany
Boehringer Ingelheim
Huska, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2007
First Posted
October 4, 2007
Study Start
March 1, 2007
Primary Completion
December 1, 2007
Last Updated
November 1, 2013
Record last verified: 2013-10