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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 |
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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:
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 |