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NCT Number: NCT00914134

Duodenal Levodopa Infusion, Quality of Life and Autonomic Nervous System in 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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Helsinki University Central Hospital, Department of Neurology

Helsinki, 00250, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levodopa infusion

Drug

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

Primary outcomes

  1. 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

  1. Sweating measured by evaporimeter

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

  2. Autonomic nervous system symptoms questionnaire (NMSS)

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

  3. Quality of life questionnaire (PDQ-39)

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

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Collaborators

  • Solvay Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 4, 2009
Registry last updated
Feb 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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