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

Sponsor
University of Helsinki (Other)
Overall Status
Completed
CT.gov ID
NCT00914134
Collaborator
Solvay Pharmaceuticals (Industry)
12
Enrollment
1
Location
1
Arm
21
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Levodopa infusion
 Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Apr 1, 2009
Actual Primary Completion Date :
Jan 1, 2011
Actual Study Completion Date :
Jan 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Duodopa

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Sweating measured by evaporimeter [Before levodopa infusion, after 3-5 days of levodopa infusion, 2 months after levodopa infusion was started]

    2. Autonomic nervous system symptoms questionnaire (NMSS) [Before levodopa infusion and 2 months after levodopa infusion was started]

    3. Quality of life questionnaire (PDQ-39) [Before levodopa infusion and 2 months after levodopa infusion was started]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Helsinki University Central Hospital, Department of Neurology Helsinki Finland 00250

    Sponsors and Collaborators

    • University of Helsinki
    • Solvay Pharmaceuticals

    Investigators

    • Study Director: Eero Pekkonen, MD, PhD, Helsinki University Central Hospital, Department of Neurology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00914134
    Other Study ID Numbers:
    • PDAUT2009
    First Posted:
    Jun 4, 2009
    Last Update Posted:
    Feb 24, 2011
    Last Verified:
    Feb 1, 2011
    Keywords provided by , ,
    Parkinson's disease
    Autonomic nervous system
    Levodopa infusion
    Additional relevant MeSH terms:
    Parkinson Disease
    Levodopa

    Study Results

    No Results Posted as of Feb 24, 2011