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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00297778 |
Parkinsons Disease (PD) is caused by a decrease of dopamine in a particular part of the brain. Dopamine is a messenger substance (neurotransmitter) that is used by the cells of the brain (nerve cells) to control and harmonize muscle movements. Consequently, the main manifestations of the disease aff ect movement and include tremor, muscular rigidity, slowness in performing movements and loss of balance.
However, the disease affects also other, non motor functions and may cause other disorders, such as depression. Depression may be a reaction to the disability caused by the disease, but many studies show that depression is more common in PD than in other chronic debilitating illnesses. Moreover, t here is also a biological explanation for the phenomenon: dopamine is also used in brain circuits involved in the experience of pleasure, and loss of pleasure in daily physical or social activity is one of the key manifestations of depression.
The objective of the study is to assess whether pramipexole, at doses approved for the treatment of PD symptoms, is more effective than placebo in resolving depressive symptoms in PD patients. Also data on the safety of the product in the disease will be collected.
Condition | Intervention | Phase |
---|---|---|
Parkinson Disease Depression |
Drug: Pramipexole |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Efficacy Study of Pramipexole and Placebo Administered Orally Over a 12 Week Treatment Phase in Parkinson's Disease Patients With Stable Motor Function and Depressive Symptoms |
Enrollment: | 296 |
Study Start Date: | March 2006 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 30 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Austria | |
248.596.43001 Boehringer Ingelheim Investigational Site | |
Innsbruck, Austria | |
248.596.43002 Boehringer Ingelheim Investigational Site | |
Wien, Austria | |
248.596.43003 Boehringer Ingelheim Investigational Site | |
Graz, Austria | |
248.596.43004 Boehringer Ingelheim Investigational Site | |
St. Pölten, Austria | |
248.596.43005 Boehringer Ingelheim Investigational Site | |
Linz, Austria | |
Finland | |
248.596.35801 Boehringer Ingelheim Investigational Site | |
Oulu, Finland | |
France | |
248.596.3303A Hôpital La Timone | |
Marseille cedex 5, France | |
248.596.3305A Hôpital du Haut Levêque | |
Pessac cédex, France | |
248.596.3305B Hôpital du Haut Levêque | |
Pessac cédex, France | |
248.596.3306A Hôpital Pierre Wertheimer | |
Bron cedex, France | |
248.596.3307A Hôpital Roger Salengro | |
Lille cedex, France | |
248.596.3301A Hôpital Guillaume et René Laennec | |
Saint Herblain, France | |
248.596.3302A Centre Hospitalier du Pays d'Aix | |
Aix en Provence, France | |
248.596.3302B Centre Hospitalier du Pays d'Aix | |
Aix en Provence cedex 1, France | |
248.596.3308A Hôpital Gabriel Montpied | |
Clermont Ferrand, France | |
248.596.3307B Hôpital Roger Salengro | |
Lille cedex, France | |
248.596.3307C Hôpital Roger Salengro | |
Lille cedex, France | |
248.596.3309A Cabinet Médical | |
Evreux, France | |
Germany | |
248.596.49001 Boehringer Ingelheim Investigational Site | |
Karlsruhe, Germany | |
248.596.49002 Boehringer Ingelheim Investigational Site | |
Berlin, Germany | |
248.596.49003 Boehringer Ingelheim Investigational Site | |
Bremerhaven, Germany | |
248.596.49004 Boehringer Ingelheim Investigational Site | |
Gera, Germany | |
248.596.49005 Boehringer Ingelheim Investigational Site | |
Marburg, Germany | |
248.596.49008 Boehringer Ingelheim Investigational Site | |
München, Germany | |
248.596.49014 Boehringer Ingelheim Investigational Site | |
Mittweida, Germany | |
248.596.49016 Boehringer Ingelheim Investigational Site | |
Köln, Germany | |
248.596.49012 Boehringer Ingelheim Investigational Site | |
Berlin-Steglitz, Germany | |
248.596.49013 Boehringer Ingelheim Investigational Site | |
Berlin, Germany | |
248.596.49015 Boehringer Ingelheim Investigational Site | |
Berlin, Germany | |
Italy | |
248.596.39001 Ospedale Civile S. Spirito, Università "G. D'Annunzio" | |
Pescara, Italy | |
248.596.39002 Università degli studi di Genova | |
Genova, Italy | |
248.596.39003 Università degli studi di Napoli "Federico II" | |
Napoli, Italy | |
248.596.39004 Neurologia Ospedale della Misericordia | |
Grosseto, Italy | |
248.596.39005 Clinica Neurologica Policlinico G. Martino | |
Messina, Italy | |
248.596.39006 Neurologia Ospedale Evangelico Valdese | |
Torino, Italy | |
248.596.39007 Clinica Neurologica Policlinico Tor Vergata | |
Roma, Italy | |
248.596.39008 Clinica Neurologica I Policlinico di Catania | |
Catania, Italy | |
248.596.39009 Istituti Clinici di Perfezionamento | |
Milano, Italy | |
Netherlands | |
248.596.31002 Canisius-Wilhelmina Ziekenhuis | |
Nijmegen, Netherlands | |
248.596.31001 Maasland Ziekenhuis | |
Sittard, Netherlands | |
248.596.31003 Jeroen Bosch Ziekenhuis, locatie WA | |
's-Hertogenbosch, Netherlands | |
248.596.31005 Ziekenhuis Gooi-Noord | |
Blaricum, Netherlands | |
248.596.31004 Amphia ziekenhuis, Locatie Molengracht | |
Breda, Netherlands | |
248.596.31007 Afdeling neurologie | |
Amsterdam, Netherlands | |
Norway | |
248.596.47002 Boehringer Ingelheim Investigational Site | |
ARENDAL, Norway | |
248.596.47003 Boehringer Ingelheim Investigational Site | |
SANDVIKA, Norway | |
248.596.47004 Boehringer Ingelheim Investigational Site | |
LILLEHAMMER, Norway | |
Romania | |
248.596.40001 Boehringer Ingelheim Investigational Site | |
Cluj Napoca, Romania | |
248.596.40002 Boehringer Ingelheim Investigational Site | |
Iasi, Romania | |
248.596.40003 Boehringer Ingelheim Investigational Site | |
Bucharest, Romania | |
248.596.40004 Boehringer Ingelheim Investigational Site | |
Bucharest, Romania | |
248.596.40005 Boehringer Ingelheim Investigational Site | |
Bucharest, Romania | |
248.596.40006 Country Clinical Emergency Hospital | |
Targu-Mures, Romania | |
Russian Federation | |
248.596.70003 Boehringer Ingelheim Investigational Site | |
Moscow, Russian Federation | |
248.596.70004 Boehringer Ingelheim Investigational Site | |
St. Petersburg, Russian Federation | |
248.596.70002 Boehringer Ingelheim Investigational Site | |
St. Petersburg, Russian Federation | |
248.596.70001 Boehringer Ingelheim Investigational Site | |
Moscow, Russian Federation | |
248.596.70005 Boehringer Ingelheim Investigational Site | |
St. Petersburg, Russian Federation | |
South Africa | |
248.596.27001 Boehringer Ingelheim Investigational Site | |
Cape Town, South Africa | |
248.596.27003 Boehringer Ingelheim Investigational Site | |
Cape Town, South Africa | |
248.596.27004 Boehringer Ingelheim Investigational Site | |
Pretoria, South Africa | |
248.596.27006 Boehringer Ingelheim Investigational Site | |
Richards Bay, South Africa | |
248.596.27007 Boehringer Ingelheim Investigational Site | |
Cape Town, South Africa | |
248.596.27008 Boehringer Ingelheim Investigational Site | |
Johannesburg, South Africa | |
Spain | |
248.596.34005 Hosp. Univ. Vall d'Hebron. Departamento de Neurología | |
Barcelona, Spain | |
248.596.34002 Hospital Clinic i Provincial. Departamento de Neurología | |
Barcelona, Spain | |
248.596.34003 Hospital de Alcorcón. Departamento de Neurología | |
Alcorcon (Madrid), Spain | |
248.596.34004 Hospital General de Catalunya. Departamento de Neurología | |
San Cugat del Valles (Barcelona), Spain | |
248.596.34001 Hospital Sta Creu i Sant Pau. Departamento de Neurología | |
Barcelona, Spain | |
248.596.34007 Hosp Gral Univ Gregorio Marañón. Departamento de Neurología | |
Madrid, Spain | |
Sweden | |
248.596.46001 Boehringer Ingelheim Investigational Site | |
Stockholm, Sweden | |
248.596.46002 Boehringer Ingelheim Investigational Site | |
Stockholm, Sweden | |
248.596.46004 Boehringer Ingelheim Investigational Site | |
Linköping, Sweden | |
Ukraine | |
248.596.38003 Boehringer Ingelheim Investigational Site | |
Vinnytzya, Ukraine | |
248.596.38002 Boehringer Ingelheim Investigational Site | |
Kiev, Ukraine | |
248.596.38005 Boehringer Ingelheim Investigational Site | |
Kharkiv, Ukraine | |
248.596.38006 Boehringer Ingelheim Investigational Site | |
Simferopol, Ukraine | |
248.596.38004 Boehringer Ingelheim Investigational Site | |
Donetsk, Ukraine |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 248.596, Eudract 2005-003788-22 |
Study First Received: | February 28, 2006 |
Last Updated: | April 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00297778 History of Changes |
Health Authority: | Austria: Federal Office for Safety in Health Care; Finland: National Agency for Medicines; France: Afssaps; Germany: Ethikkommission bei der Landesaerztekammer Baden-Wuerttemberg; Italy: Comitato Etico Ospedale Civile S. Spirito, Università "G. D'Annunzio"; Netherlands: Medish Etische toetsingscommissie Atrium MC; Norway: Norwegian Medicines Agency (Statens Legemiddelverk); Romania: National Medicines Agency, Bucharest; Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow; South Africa: Medicines Council Country; Spain: Unidad de Registro y Tasas, Agencia Espanola del medicamento y productos sanitarios; Sweden: Medical Products Agency; Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine) |
Neurotransmitter Agents Depression Ganglion Cysts Antioxidants Basal Ganglia Diseases Central Nervous System Diseases Dopamine Agonists Depressive Disorder Brain Diseases |
Neurodegenerative Diseases Pramipexol Behavioral Symptoms Dopamine Parkinson Disease Movement Disorders Dopamine Agents Parkinsonian Disorders |
Neurotransmitter Agents Depression Antioxidants Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Basal Ganglia Diseases Nervous System Diseases Antiparkinson Agents Central Nervous System Diseases Dopamine Agonists Brain Diseases |
Neurodegenerative Diseases Protective Agents Pharmacologic Actions Pramipexol Behavioral Symptoms Parkinson Disease Movement Disorders Therapeutic Uses Dopamine Agents Parkinsonian Disorders Central Nervous System Agents |