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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
History of Changes

June 1, 2009
February 23, 2011
April 2009
January 2011   (final data collection date for primary outcome measure)
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 ]
Orthostatic blood pressure change [ Time Frame: Before levodopa infusion, after 3-5 days of levodopa infusion, 2 and 6 months after levodopa infusion was started ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00914134 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Sweating measured by evaporimeter [ Time Frame: Before levodopa infusion, after 3-5 days of levodopa infusion, 2 and 6 months after levodopa infusion was started ] [ Designated as safety issue: No ]
  • Autonomic nervous system symptoms questionnaire (NMSS) [ Time Frame: Before levodopa infusion, 2 and 6 months after levodopa infusion was started ] [ Designated as safety issue: No ]
  • Quality of life questionnaire (PDQ-39) [ Time Frame: Before levodopa infusion, 2 and 6 months after levodopa infusion was started ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Duodenal Levodopa Infusion, Quality of Life and Autonomic Nervous System in Parkinson's Disease
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.

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.
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Parkinson's Disease
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
Experimental: Levodopa Infusion
Patients with advanced Parkinson's disease and motor fluctuations that cannot be adequately controlled with oral medication.
Intervention: Drug: Levodopa infusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
January 2011
January 2011   (final data collection date for primary outcome measure)

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.
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00914134
PDAUT2009
No
Eero Pekkonen, Helsinki University Central Hospital, Department of Neurology
Helsinki University
Solvay Pharmaceuticals
Study Director: Eero Pekkonen, MD, PhD Helsinki University Central Hospital, Department of Neurology
Helsinki University
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP