Duodenal Levodopa Infusion, Quality of Life and Autonomic Nervous System in Parkinson's Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Duodenal Levodopa Infusion on Quality of Life and Autonomic Dysfunction in Patients With Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: Levodopa infusion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levodopa Infusion<br>Patients with advanced Parkinson's disease and motor fluctuations that cannot be adequately controlled with oral medication. | Drug: Levodopa infusion<br>* 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.<br>* Other names: Duodopa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Autonomic nervous system, Levodopa infusion