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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, there 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 o ne 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, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 280 |
Estimated Study Completion Date: | October 2008 |
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 Study Coordinator | BI France S.A.S. |
Study ID Numbers: | 248.596, EudraCT No.: 2005-003788-22 |
Study First Received: | February 28, 2006 |
Last Updated: | July 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00297778 |
Health Authority: | Finland: National Agency for Medicines; Norway: Norwegian Medicines Agency (Statens Legemiddelverk); Spain: Unidad de Registro y Tasas, Agencia Espanola del medicamento y productos sanitarios; Sweden: Medical Products Agency; Germany: Ethikkommission bei der Landesaerztekammer Baden-Wuerttemberg; Austria: National Medicines Agency, Bucharest; Austria: Bundesministerium fur Gesundheit und Frauen; Italy: Comitato Etico Ospedale Civile S. Spirito, Universita "G. D'Annunzio"; Netherlands: Medish Etische toetsingscommissie Atrium MC; Great Britain: Medicines and Healthcare products Regulatory Agency; France: Afssaps; South Africa: Medicines Council Country; Austria: Bundesamt fur Sicherheit im Gesundheitswesen, A-1030 Vienna |
Depression Ganglion Cysts Basal Ganglia Diseases Central Nervous System Diseases Depressive Disorder Brain Diseases Neurodegenerative Diseases |
Pramipexol Behavioral Symptoms Dopamine Parkinson Disease Movement Disorders Parkinsonian Disorders |
Neurotransmitter Agents Antioxidants Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Nervous System Diseases Physiological Effects of Drugs Antiparkinson Agents |
Dopamine Agonists Protective Agents Pharmacologic Actions Therapeutic Uses Dopamine Agents Central Nervous System Agents |