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

University of Helsinki12 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Parkinson's Disease

Interventions

Levodopa infusionDRUG

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Helsinki University Central Hospital, Department of Neurology

Helsinki, Finland

Outcomes

Primary Outcomes

Orthostatic blood pressure change

Time frame: Before levodopa infusion, after 3-5 days of levodopa infusion and 2 months after levodopa infusion was started

Secondary Outcomes

Sweating measured by evaporimeter

Time frame: Before levodopa infusion, after 3-5 days of levodopa infusion, 2 months after levodopa infusion was started

Autonomic nervous system symptoms questionnaire (NMSS)

Time frame: Before levodopa infusion and 2 months after levodopa infusion was started

Quality of life questionnaire (PDQ-39)

Time frame: Before levodopa infusion and 2 months after levodopa infusion was started

Data from ClinicalTrials.gov

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