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Tracking Information | |||||
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First Received Date † | February 28, 2006 | ||||
Last Updated Date | April 24, 2009 | ||||
Start Date † | March 2006 | ||||
Current Primary Outcome Measures † |
The primary endpoint for this study is clinical response after 12 weeks of treatment, defined as a change in total score of baseline symptoms as measured by the BDI total score. [ Time Frame: 12 weeks ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00297778 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
changes from Baseline BDI 50 percent reduction SHAPS total score UPDRS II, III, IV QoL scales PDQ 39 and EQ 5D (CGI-I) VAS for pain adverse events Withdrawals due to AE Change in vital signs [ Time Frame: 12 weeks ] | ||||
Original Secondary Outcome Measures † |
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Descriptive Information | |||||
Brief Title † | Pramipexole Versus Placebo in PD Patients With Depressive Symptoms | ||||
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 | ||||
Brief Summary | 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. |
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Detailed Description | |||||
Study Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Parallel Assignment | ||||
Condition † |
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Intervention † | Drug: Pramipexole | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 296 | ||||
Completion Date | |||||
Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 30 Years to 80 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | Austria, Finland, France, Germany, Italy, Netherlands, Norway, Romania, Russian Federation, South Africa, Spain, Sweden, Ukraine | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00297778 | ||||
Responsible Party | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim | ||||
Secondary IDs †† | Eudract 2005-003788-22 | ||||
Study Sponsor † | Boehringer Ingelheim Pharmaceuticals | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Boehringer Ingelheim Pharmaceuticals | ||||
Verification Date | April 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |