Parkinson's Disease
Conditions
Keywords
Parkinson's disease, Autonomic nervous system, Levodopa infusion
Brief summary
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.
Detailed description
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.
Interventions
DRUGLevodopa 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.
Sponsors
Solvay Pharmaceuticals
University of Helsinki
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of idiopathic Parkinson's disease: diagnosis made at least five years earlier * Positive response to levodopa * Motor fluctuations that cannot be adequately controlled with oral medication * No signs or symptoms of cerebellar dysfunction or vascular parkinsonism
Exclusion criteria
* Severe cognitive symptoms * Glaucoma * Severe arrythmias * Severe asthma or COPD * Heart, liver or kidney failure * No significant vascular lesions in brain MRI imaging.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Orthostatic blood pressure change | Before levodopa infusion, after 3-5 days of levodopa infusion and 2 months after levodopa infusion was started |
Secondary
| Measure | Time frame |
|---|---|
| Sweating measured by evaporimeter | Before levodopa infusion, after 3-5 days of levodopa infusion, 2 months after levodopa infusion was started |
| Autonomic nervous system symptoms questionnaire (NMSS) | Before levodopa infusion and 2 months after levodopa infusion was started |
| Quality of life questionnaire (PDQ-39) | Before levodopa infusion and 2 months after levodopa infusion was started |
Countries
Finland
Outcome results
None listed