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

This study has been completed.
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by:
Helsinki University
ClinicalTrials.gov Identifier:
NCT00914134
First received: June 1, 2009
Last updated: February 23, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Parkinson's Disease
Drug: Levodopa infusion
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • Orthostatic blood pressure change [ Time Frame: Before levodopa infusion, after 3-5 days of levodopa infusion and 2 months after levodopa infusion was started ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sweating measured by evaporimeter [ Time Frame: Before levodopa infusion, after 3-5 days of levodopa infusion, 2 months after levodopa infusion was started ] [ Designated as safety issue: No ]
  • Autonomic nervous system symptoms questionnaire (NMSS) [ Time Frame: Before levodopa infusion and 2 months after levodopa infusion was started ] [ Designated as safety issue: No ]
  • Quality of life questionnaire (PDQ-39) [ Time Frame: Before levodopa infusion and 2 months after levodopa infusion was started ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: April 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Duodopa

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00914134

Locations
Finland
Helsinki University Central Hospital, Department of Neurology
Helsinki, Finland, 00250
Sponsors and Collaborators
Helsinki University
Solvay Pharmaceuticals
Investigators
Study Director: Eero Pekkonen, MD, PhD Helsinki University Central Hospital, Department of Neurology
  More Information

No publications provided

Responsible Party: Eero Pekkonen, Helsinki University Central Hospital, Department of Neurology
ClinicalTrials.gov Identifier: NCT00914134     History of Changes
Other Study ID Numbers: PDAUT2009
Study First Received: June 1, 2009
Last Updated: February 23, 2011
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Helsinki University:
Parkinson's disease
Autonomic nervous system
Levodopa infusion

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014