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

February 23, 2011 updated by: University of Helsinki

Effect of Duodenal Levodopa Infusion on Quality of Life and Autonomic Dysfunction in Patients With 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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00250
        • Helsinki University Central Hospital, Department of Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Orthostatic blood pressure change
Time Frame: Before levodopa infusion, after 3-5 days of levodopa infusion and 2 months after levodopa infusion was started
Before levodopa infusion, after 3-5 days of levodopa infusion and 2 months after levodopa infusion was started

Secondary Outcome Measures

Outcome Measure
Time Frame
Sweating measured by evaporimeter
Time Frame: Before levodopa infusion, after 3-5 days of levodopa infusion, 2 months after levodopa infusion was started
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
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
Before levodopa infusion and 2 months after levodopa infusion was started

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Collaborators

Solvay Pharmaceuticals

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

June 1, 2009

First Submitted That Met QC Criteria

June 3, 2009

First Posted (Estimate)

June 4, 2009

Study Record Updates

Last Update Posted (Estimate)

February 24, 2011

Last Update Submitted That Met QC Criteria

February 23, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDAUT2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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