Back to resultsDuodenal Levodopa Infusion, Quality of Life and Autonomic Nervous System in Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Levodopa infusion
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Autonomic nervous system, Levodopa infusion
Eligibility 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.
Sites / Locations
- Helsinki University Central Hospital, Department of Neurology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Levodopa Infusion
Arm Description
Patients with advanced Parkinson's disease and motor fluctuations that cannot be adequately controlled with oral medication.
Outcomes
Primary Outcome Measures
Orthostatic blood pressure change
Secondary Outcome Measures
Sweating measured by evaporimeter
Autonomic nervous system symptoms questionnaire (NMSS)
Quality of life questionnaire (PDQ-39)
Full Information
NCT ID
NCT00914134
First Posted
June 1, 2009
Last Updated
February 23, 2011
Sponsor
University of Helsinki
Collaborators
Solvay Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00914134
Brief Title
Duodenal Levodopa Infusion, Quality of Life and Autonomic Nervous System in Parkinson's Disease
Official Title
Effect of Duodenal Levodopa Infusion on Quality of Life and Autonomic Dysfunction in Patients With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Helsinki
Collaborators
Solvay Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Autonomic nervous system, Levodopa infusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levodopa Infusion
Arm Type
Experimental
Arm Description
Patients with advanced Parkinson's disease and motor fluctuations that cannot be adequately controlled with oral medication.
Intervention Type
Drug
Intervention Name(s)
Levodopa infusion
Other Intervention Name(s)
Duodopa
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Sweating measured by evaporimeter
Time Frame
Before levodopa infusion, after 3-5 days of levodopa infusion, 2 months after levodopa infusion was started
Title
Autonomic nervous system symptoms questionnaire (NMSS)
Time Frame
Before levodopa infusion and 2 months after levodopa infusion was started
Title
Quality of life questionnaire (PDQ-39)
Time Frame
Before levodopa infusion and 2 months after levodopa infusion was started
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eero Pekkonen, MD, PhD
Organizational Affiliation
Helsinki University Central Hospital, Department of Neurology
Official's Role
Study Director
Facility Information:
Facility Name
Helsinki University Central Hospital, Department of Neurology
City
Helsinki
ZIP/Postal Code
00250
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Duodenal Levodopa Infusion, Quality of Life and Autonomic Nervous System in Parkinson's Disease
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