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

NCT00914134 — Phase 4, Completed, 12 participants, University of Helsinki

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

Registry	NCT00914134
Status	Completed
Phase	Phase 4
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	12 (Actual)
Sponsor	University of Helsinki (Other); collaborators: Solvay Pharmaceuticals
Conditions	Parkinson's Disease
Interventions	Levodopa infusion (Drug)
Dates	start 2009-04-01, primary completion 2011-01-01, completion 2011-01-01, first posted 2009-06-04, last updated 2011-02-24
Locations	1 site in Finland

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Levodopa Infusion	Experimental	Drug: Levodopa infusion	Patients with advanced Parkinson's disease and motor fluctuations that cannot be adequately controlled with oral medication.

Levodopa infusion (Drug), also known as Duodopa: 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.

+Outcome measures

Primary outcomes

Orthostatic blood pressure change [Before levodopa infusion, after 3-5 days of levodopa infusion and 2 months after levodopa infusion was started]

Secondary outcomes

Sweating measured by evaporimeter [Before levodopa infusion, after 3-5 days of levodopa infusion, 2 months after levodopa infusion was started]
Autonomic nervous system symptoms questionnaire (NMSS) [Before levodopa infusion and 2 months after levodopa infusion was started]
Quality of life questionnaire (PDQ-39) [Before levodopa infusion and 2 months after levodopa infusion was started]

+Eligibility

Sex: All, ages: 40 Years to 80 Years

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.

+Locations (1)

Facility	City	Country	Status
Helsinki University Central Hospital, Department of Neurology	Helsinki	Finland

+Investigators

Eero Pekkonen, MD, PhD, Study director, Helsinki University Central Hospital, Department of Neurology