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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00349310
Other study ID # 248.597
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2006
Est. completion date October 1, 2006

Study information

Verified date December 2023
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To explore or establish the relationship between cognitive, mood and motor symptoms in PD to scores on depression rating scales in a naturalistic setting.


Recruitment information / eligibility

Status Completed
Enrollment 1018
Est. completion date October 1, 2006
Est. primary completion date October 1, 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion_Criteria: Observation criteria: - are able to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation - have idiopathic Parkinsons disease according to the United Kingdom Parkinsons Disease Society Brain Bank Diagnostic Criteria for Parkinsons disease - show no impairment of cognitive function (MMSE score ?24) - are with or without symptoms of depression (full range) - are stable on anti-Parkinson/anti-depressive treatment for at least 1 month before entering the study - are or are not on concomitant antidepressant treatment - are in the on state during the observation period - did not previously undergo PD surgery

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Pramipexole


Locations

Country Name City State
Austria Boehringer Ingelheim Investigational Site Innsbruck
Austria Boehringer Ingelheim Investigational Site Wien
Austria Boehringer Ingelheim Investigational Site Wien
France Hopital Purpan Toulouse cedex
France Hopital Rangueil Toulouse cedex 9
Germany Neurologisches Fachkrankenhaus fur Beelitz-Heilstatten
Germany Universitatsklinikum Carl Gustav Carus Dresden Dresden
Germany Boehringer Ingelheim Investigational Site Gera
Germany Gertrudis-Kliniken Biskirchen Leun
Germany Boehringer Ingelheim Investigational Site Unterhaching
Germany Parkinson Klinik Wolfach Wolfach
Italy Policlinico di Catania Catania
Italy Azienda Ospedaliera S. Martino Genova
Italy Universita Federico II Napoli
Italy Universita La Sapienza di Roma Roma
Netherlands Academisch Ziekenhuis Maastricht Maastricht
Spain Hospital de Cruces. Neurology Baracaldo / Bilbao
Spain Hospital Clinic i Provincial. Neurology Barcelona
Spain Hospital Puerta del Mar. Neurology Cadiz
Switzerland Clinica Hildebrand Brissago
Switzerland Hopital Cantonal (HUG) Geneve
Switzerland Kantonsspital St. Gallen St.Gallen
United Kingdom Boehringer Ingelheim Investigational Site London
United Kingdom Boehringer Ingelheim Investigational Site Newark

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Austria,  France,  Germany,  Italy,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary HADS, HAMD-17, BDI-1A, FAB (cognitive), DSM-IV (mood- part A, B, C, E) and UPDRS Up to 6 months
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