Duodenal Levodopa Infusion, Quality of Life and Autonomic Nervous System in Parkinson's Disease
The aim of the study is to assess the effect of continuous levodopa infusion on autonomic nervous system in patients with Parkinson's Disease (PD), blood pressure regulation and sweating. The investigators' hypothesis is that levodopa infusion may alleviate hyperhidrosis and orthostatic hypotension.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of Duodenal Levodopa Infusion on Quality of Life and Autonomic Dysfunction in Patients With Parkinson's Disease|
- Orthostatic blood pressure change [ Time Frame: Before levodopa infusion, after 3-5 days of levodopa infusion and 2 months after levodopa infusion was started ] [ Designated as safety issue: No ]
- Sweating measured by evaporimeter [ Time Frame: Before levodopa infusion, after 3-5 days of levodopa infusion, 2 months after levodopa infusion was started ] [ Designated as safety issue: No ]
- Autonomic nervous system symptoms questionnaire (NMSS) [ Time Frame: Before levodopa infusion and 2 months after levodopa infusion was started ] [ Designated as safety issue: No ]
- Quality of life questionnaire (PDQ-39) [ Time Frame: Before levodopa infusion and 2 months after levodopa infusion was started ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Experimental: Levodopa Infusion
Patients with advanced Parkinson's disease and motor fluctuations that cannot be adequately controlled with oral medication.
Drug: Levodopa infusion
Naso-duodenal infusion line is inserted in fluoroscopy control. Levodopa infusion is then tested approximately 5 days. If patient responds favorably to the treatment, PEG-infusion line is inserted in gastroscopy control and patient is followed in hospital for 2 to 4 days to ensure stability of the infusion line. The dosage is individually adjusted, starting dose is estimated from earlier oral levodopa dose.
Other Name: Duodopa
Parkinson's disease (PD) is one of the most common neurodegenerative disorders with increasing prevalence because of aging population. The main symptoms include rigidity, hypokinesia, tremor and impaired balance, but the disease also causes autonomic dysfunction. Motor fluctuations are common treatment related problems in PD, around 50-70% of patients treated with levodopa finally develop motor fluctuations. Continuous duodenal levodopa infusion has been effective in the treatment of motor dysfunction in advanced PD. However, little is known of its effects on autonomic nervous system.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00914134
|Helsinki University Central Hospital, Department of Neurology|
|Helsinki, Finland, 00250|
|Study Director:||Eero Pekkonen, MD, PhD||Helsinki University Central Hospital, Department of Neurology|