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Parkinson DiseaseNCT00539214

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

An observational study of Parkinson Disease, run by Boehringer Ingelheim at 317 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson Disease
How many people
1,192 participants
Where
317 sitesGermany
Study dates
Mar 2007to Dec 2007
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: PD patients

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

317 sites in 1 country.

300 sites in 1 country

Germany300 sites

  • Boehringer Ingelheim

    Aalen

  • Boehringer Ingelheim

    Aarbergen

  • Boehringer Ingelheim

    Adendorf

  • Boehringer Ingelheim

    Aham

  • Boehringer Ingelheim

    Ahaus

  • Boehringer Ingelheim

    Ahlen

  • Boehringer Ingelheim

    Ahorntal

  • Boehringer Ingelheim

    Aichach

  • Boehringer Ingelheim

    Aislingen

  • Boehringer Ingelheim

    Albstadt

  • Boehringer Ingelheim

    Aldenhoven

  • Boehringer Ingelheim

    Aldingen

  • Boehringer Ingelheim

    Alfeld

  • Boehringer Ingelheim

    Alpirsbach

  • Boehringer Ingelheim

    Alsdorf

  • Boehringer Ingelheim

    Altena

  • Boehringer Ingelheim

    Altenstadt

  • Boehringer Ingelheim

    Altomünster

  • Boehringer Ingelheim

    Alveslohe

  • Boehringer Ingelheim

    Amberg

  • Boehringer Ingelheim

    Ammerbuch

  • Boehringer Ingelheim

    Andernach

  • Boehringer Ingelheim

    Anklam

  • Boehringer Ingelheim

    Apolda

  • Boehringer Ingelheim

    Armsheim

  • Boehringer Ingelheim

    Arzberg

  • Boehringer Ingelheim

    Aschaffenburg

  • Boehringer Ingelheim

    Aschersleben

  • Boehringer Ingelheim

    Aschheim

  • Boehringer Ingelheim

    Attendorn

  • Boehringer Ingelheim

    Auerbach

  • Boehringer Ingelheim

    Augsburg

  • Boehringer Ingelheim

    Aurich

  • Boehringer Ingelheim

    Babensham

  • Boehringer Ingelheim

    Backnang

  • Boehringer Ingelheim

    Bad Arolsen

  • Boehringer Ingelheim

    Bad Berleburg

  • Boehringer Ingelheim

    Bad Bevensen

  • Boehringer Ingelheim

    Bad Düben

  • Boehringer Ingelheim

    Bad Dürrenberg

  • Boehringer Ingelheim

    Bad Dürrheim

  • Boehringer Ingelheim

    Bad Ems

  • Boehringer Ingelheim

    Bad Essen

  • Boehringer Ingelheim

    Bad Kreuznach

  • Boehringer Ingelheim

    Bad Laasphe

  • Boehringer Ingelheim

    Bad Langensalza

  • Boehringer Ingelheim

    Bad Lausick

  • Boehringer Ingelheim

    Bad Münstereifel

  • Boehringer Ingelheim

    Bad Oeynhausen

  • Boehringer Ingelheim

    Bad Salzungen

  • Boehringer Ingelheim

    Bad Schwalbach

  • Boehringer Ingelheim

    Bad Schwartau

  • Boehringer Ingelheim

    Bad Segeberg

  • Boehringer Ingelheim

    Bad Tennstedt

  • Boehringer Ingelheim

    Bad Waldsee

  • Boehringer Ingelheim

    Baden-Baden

  • Boehringer Ingelheim

    Bahrdorf

  • Boehringer Ingelheim

    Baltmannsweiler

  • Boehringer Ingelheim

    Bamberg

  • Boehringer Ingelheim

    Barleben

  • Boehringer Ingelheim

    Bärnau

  • Boehringer Ingelheim

    Baunatal

  • Boehringer Ingelheim

    Bautzen

  • Boehringer Ingelheim

    Bayreuth

  • Boehringer Ingelheim

    Beckum

  • Boehringer Ingelheim

    Beeskow

  • Boehringer Ingelheim

    Bellheim

  • Boehringer Ingelheim

    Belm

  • Boehringer Ingelheim

    Bensheim

  • Boehringer Ingelheim

    Berching

  • Boehringer Ingelheim

    Bergfelde

  • Boehringer Ingelheim

    Bergheim

  • Boehringer Ingelheim

    Bergisch Gladbach

  • Boehringer Ingelheim

    Berkheim

  • Boehringer Ingelheim

    Berlin

  • Boehringer Ingelheim

    Berne

  • Boehringer Ingelheim

    Bernsdorf

  • Boehringer Ingelheim

    Betzdorf

  • Boehringer Ingelheim

    Biebertal

  • Boehringer Ingelheim

    Bielefeld

  • Boehringer Ingelheim

    Bienenbüttel

  • Boehringer Ingelheim

    Bippen

  • Boehringer Ingelheim

    Birkenfeld

  • Boehringer Ingelheim

    Birkenwerder

  • Boehringer Ingelheim

    Blankenhain

  • Boehringer Ingelheim

    Blaustein

  • Boehringer Ingelheim

    Blieskastel

  • Boehringer Ingelheim

    Bobritzsch

  • Boehringer Ingelheim

    Bocholt

  • Boehringer Ingelheim

    Bochum

  • Boehringer Ingelheim

    Bockenem

  • Boehringer Ingelheim

    Bodelshausen

  • Boehringer Ingelheim

    Bodenfelde

  • Boehringer Ingelheim

    Bodenkirchen

  • Boehringer Ingelheim

    Bodenwöhr

  • Boehringer Ingelheim

    Bodman-Ludwigshafen

  • Boehringer Ingelheim

    Böhlen

  • Boehringer Ingelheim

    Bollendorf

  • Boehringer Ingelheim

    Bonn

  • Boehringer Ingelheim

    Bopfingen

  • Boehringer Ingelheim

    Borgholzhausen

  • Boehringer Ingelheim

    Borken

  • Boehringer Ingelheim

    Borna

  • Boehringer Ingelheim

    Bornheim

  • Boehringer Ingelheim

    Bösel

  • Boehringer Ingelheim

    Bottendorf

  • Boehringer Ingelheim

    Bottmersdorf

  • Boehringer Ingelheim

    Bottrop

  • Boehringer Ingelheim

    Bovenden

  • Boehringer Ingelheim

    Brake

  • Boehringer Ingelheim

    Brandenburg

  • Boehringer Ingelheim

    Brannenburg

  • Boehringer Ingelheim

    Braunschweig

  • Boehringer Ingelheim

    Brechen

  • Boehringer Ingelheim

    Breitenbrunn

  • Boehringer Ingelheim

    Bremen

  • Boehringer Ingelheim

    Bremerhaven

  • Boehringer Ingelheim

    Brensbach

  • Boehringer Ingelheim

    Breuberg

  • Boehringer Ingelheim

    Bruchköbel

  • Boehringer Ingelheim

    Brunsbüttel

  • Boehringer Ingelheim

    Buchbach

  • Boehringer Ingelheim

    Bückeburg

  • Boehringer Ingelheim

    Buckow

  • Boehringer Ingelheim

    Buedelsdorf

  • Boehringer Ingelheim

    Bünde

  • Boehringer Ingelheim

    Burg

  • Boehringer Ingelheim

    Burgau

  • Boehringer Ingelheim

    Burgdorf, Hanover

  • Boehringer Ingelheim

    Burgpreppach

  • Boehringer Ingelheim

    Burtenbach

  • Boehringer Ingelheim

    Büttelborn

  • Boehringer Ingelheim

    Buttstädt

  • Boehringer Ingelheim

    Butzbach

  • Boehringer Ingelheim

    Cadolzburg

  • Boehringer Ingelheim

    Calbe

  • Boehringer Ingelheim

    Calberlah

  • Boehringer Ingelheim

    Castrop-Rauxel

  • Boehringer Ingelheim

    Celle

  • Boehringer Ingelheim

    Chemnitz

  • Boehringer Ingelheim

    Cochem

  • Boehringer Ingelheim

    Coppenbrügge

  • Boehringer Ingelheim

    Crimmitschau

  • Boehringer Ingelheim

    Crivitz

  • Boehringer Ingelheim

    Cuxhaven

  • Boehringer Ingelheim

    Dabel

  • Boehringer Ingelheim

    Darmstadt

  • Boehringer Ingelheim

    Dassow

  • Boehringer Ingelheim

    Datteln

  • Boehringer Ingelheim

    Daun

  • Boehringer Ingelheim

    Deggendorf

  • Boehringer Ingelheim

    Deidesheim

  • Boehringer Ingelheim

    Deining

  • Boehringer Ingelheim

    Delitzsch

  • Boehringer Ingelheim

    Demen

  • Boehringer Ingelheim

    Denkendorf

  • Boehringer Ingelheim

    Dessau

  • Boehringer Ingelheim

    Detmold

  • Boehringer Ingelheim

    Dettenheim

  • Boehringer Ingelheim

    Deuben

  • Boehringer Ingelheim

    Deutzen

  • Boehringer Ingelheim

    Diepholz

  • Boehringer Ingelheim

    Dillingen

  • Boehringer Ingelheim

    Dingolfing

  • Boehringer Ingelheim

    Dinkelsbühl

  • Boehringer Ingelheim

    Dinslaken

  • Boehringer Ingelheim

    Dissen

  • Boehringer Ingelheim

    Dogern

  • Boehringer Ingelheim

    Dollern

  • Boehringer Ingelheim

    Donaueschingen

  • Boehringer Ingelheim

    Dörentrup

  • Boehringer Ingelheim

    Dormagen

  • Boehringer Ingelheim

    Dornstetten

  • Boehringer Ingelheim

    Dörpen

  • Boehringer Ingelheim

    Dorsten

  • Boehringer Ingelheim

    Dortmund

  • Boehringer Ingelheim

    Dreieich

  • Boehringer Ingelheim

    Drensteinfurt

  • Boehringer Ingelheim

    Dresden

  • Boehringer Ingelheim

    Driedorf

  • Boehringer Ingelheim

    Duderstadt

  • Boehringer Ingelheim

    Duisburg

  • Boehringer Ingelheim

    Dummerstorf

  • Boehringer Ingelheim

    Düren

  • Boehringer Ingelheim

    Düsseldorf

  • Boehringer Ingelheim

    Ebergötzen

  • Boehringer Ingelheim

    Ebermannstadt

  • Boehringer Ingelheim

    Eberstadt

  • Boehringer Ingelheim

    Ebhausen

  • Boehringer Ingelheim

    Edewecht

  • Boehringer Ingelheim

    Edling

  • Boehringer Ingelheim

    Egelsbach

  • Boehringer Ingelheim

    Ehingen

  • Boehringer Ingelheim

    Eilenburg

  • Boehringer Ingelheim

    Eisenhüttenstadt

  • Boehringer Ingelheim

    Eiterfeld

  • Boehringer Ingelheim

    Eitorf

  • Boehringer Ingelheim

    Ellwangen

  • Boehringer Ingelheim

    Elmshorn

  • Boehringer Ingelheim

    Emersacker

  • Boehringer Ingelheim

    Emmendingen

  • Boehringer Ingelheim

    Emsdetten

  • Boehringer Ingelheim

    Enger

  • Boehringer Ingelheim

    Enkenbach-Alsenborn

  • Boehringer Ingelheim

    Ennepetal

  • Boehringer Ingelheim

    Ennigerloh

  • Boehringer Ingelheim

    Eppstein

  • Boehringer Ingelheim

    Erding

  • Boehringer Ingelheim

    Erftstadt

  • Boehringer Ingelheim

    Erkrath

  • Boehringer Ingelheim

    Erligheim

  • Boehringer Ingelheim

    Erndtebrück

  • Boehringer Ingelheim

    Erolzheim

  • Boehringer Ingelheim

    Eschborn

  • Boehringer Ingelheim

    Eschelbronn

  • Boehringer Ingelheim

    Eschweiler

  • Boehringer Ingelheim

    Eslohe

  • Boehringer Ingelheim

    Espenhain

  • Boehringer Ingelheim

    Essen

  • Boehringer Ingelheim

    Esslingen am Neckar

  • Boehringer Ingelheim

    Euskirchen

  • Boehringer Ingelheim

    Filderstadt

  • Boehringer Ingelheim

    Floh-Seligenthal

  • Boehringer Ingelheim

    Flöha

  • Boehringer Ingelheim

    Forbach

  • Boehringer Ingelheim

    Forchheim

  • Boehringer Ingelheim

    Frankenberg

  • Boehringer Ingelheim

    Frankenthal

  • Boehringer Ingelheim

    Frankfurt

  • Boehringer Ingelheim

    Freiberg

  • Boehringer Ingelheim

    Freiburg im Breisgau

  • Boehringer Ingelheim

    Freigericht

  • Boehringer Ingelheim

    Freudenstadt

  • Boehringer Ingelheim

    Freyung

  • Boehringer Ingelheim

    Friedland

  • Boehringer Ingelheim

    Friedrichshafen

  • Boehringer Ingelheim

    Friedrichsthal

  • Boehringer Ingelheim

    Frohburg

  • Boehringer Ingelheim

    Fulda

  • Boehringer Ingelheim

    Fürstenwalde

  • Boehringer Ingelheim

    Furtwangen im Schwarzwald

  • Boehringer Ingelheim

    Füssen

  • Boehringer Ingelheim

    Gangelt

  • Boehringer Ingelheim

    Gardelegen

  • Boehringer Ingelheim

    Garmisch-Partenkirchen

  • Boehringer Ingelheim

    Gars

  • Boehringer Ingelheim

    Gebesee

  • Boehringer Ingelheim

    Geesthacht

  • Boehringer Ingelheim

    Gelbensande

  • Boehringer Ingelheim

    Gelsenkirchen

  • Boehringer Ingelheim

    Gensingen

  • Boehringer Ingelheim

    Georgsmarienhütte

  • Boehringer Ingelheim

    Gera

  • Boehringer Ingelheim

    Gerbstedt

  • Boehringer Ingelheim

    Germering

  • Boehringer Ingelheim

    Germersheim

  • Boehringer Ingelheim

    Gevelsberg

  • Boehringer Ingelheim

    Giessen

  • Boehringer Ingelheim

    Gifhorn

  • Boehringer Ingelheim

    Gilserberg

  • Boehringer Ingelheim

    Gladbeck

  • Boehringer Ingelheim

    Gleichen

  • Boehringer Ingelheim

    Goch

  • Boehringer Ingelheim

    Gochsheim

  • Boehringer Ingelheim

    Göllheim

  • Boehringer Ingelheim

    Göllingen

  • Boehringer Ingelheim

    Gomaringen

  • Boehringer Ingelheim

    Göttingen

  • Boehringer Ingelheim

    Grafenau

  • Boehringer Ingelheim

    Gransee

  • Boehringer Ingelheim

    Grassau

  • Boehringer Ingelheim

    Greiz

  • Boehringer Ingelheim

    Greven

  • Boehringer Ingelheim

    Grevesmühlen

  • Boehringer Ingelheim

    Griesheim

  • Boehringer Ingelheim

    Grömitz

  • Boehringer Ingelheim

    Gronau

  • Boehringer Ingelheim

    Groß Grönau

  • Boehringer Ingelheim

    Groß Quenstedt

  • Boehringer Ingelheim

    Groß-Zimmern

  • Boehringer Ingelheim

    Großalmerode

  • Boehringer Ingelheim

    Großbottwar

  • Boehringer Ingelheim

    Großefehn

  • Boehringer Ingelheim

    Großhabersdorf

  • Boehringer Ingelheim

    Großkorbetha

  • Boehringer Ingelheim

    Großlangheim

  • Boehringer Ingelheim

    Grünbach

  • Boehringer Ingelheim

    Gummersbach

  • Boehringer Ingelheim

    Güstrow

  • Boehringer Ingelheim

    Haag

  • Boehringer Ingelheim

    Hagen

  • Boehringer Ingelheim

    Haigerloch

  • Boehringer Ingelheim

    Haldensleben I

  • Boehringer Ingelheim

    Halle

  • Boehringer Ingelheim

    Hamburg

  • Boehringer Ingelheim

    Hamm

  • Boehringer Ingelheim

    Hamminkeln

  • Boehringer Ingelheim

    Hanau

  • Boehringer Ingelheim

    Hanerau-Hademarschen

  • Boehringer Ingelheim

    Hanover

Other trials in Germany

About this study

Official title: 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)
Read the detailed description

Study Design:

Medical subject headings
Parkinson Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement of depressive symptoms (UPDRS item 3, HADS-D) compared to baseline in early and advanced Parkinsons's disease

    Measured: 9-16 weeks

  2. Change in sum scores of UPDRS Part III (motor examination) from baseline and UPDRS Part I (mentation, behavior and mood) from baseline

    Measured: 9-16 weeks

  3. Change in HADS subscores (anxiety and depression) from baseline

    Measured: 9-16 weeks

Secondary outcomes (3)

  1. Baseline pattern of patient rated symptom list (HADS)

    Measured: 9-16 weeks

  2. Correlation of the change in UPDRS Part I and UPDRS Part III at the final visit

    Measured: 9-16 weeks

  3. Frequency of adverse events

    Measured: 9-16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
1,192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00539214
Sponsor's protocol ID
248.639
Status last verified
Oct 2013
First submitted
28 Sep 2007
Last updated
1 Nov 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease, run by Boehringer Ingelheim at 317 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 317 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement of depressive symptoms (UPDRS item 3, HADS-D) compared to baseline in early and advanced Parkinsons's disease (time frame: 9-16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00539214.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2013.

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