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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00914134
• Other study ID #: PDAUT2009
• Status: Completed
• Phase: Phase 4
• First received: June 1, 2009
• Last updated: February 23, 2011
• Start date: April 2009
• Est. completion date: January 2011

Study information

• Verified date: February 2011
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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.

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital, Department of Neurology	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University	Solvay Pharmaceuticals

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Orthostatic blood pressure change		Before levodopa infusion, after 3-5 days of levodopa infusion and 2 months after levodopa infusion was started	No
Secondary	Sweating measured by evaporimeter		Before levodopa infusion, after 3-5 days of levodopa infusion, 2 months after levodopa infusion was started	No
Secondary	Autonomic nervous system symptoms questionnaire (NMSS)		Before levodopa infusion and 2 months after levodopa infusion was started	No
Secondary	Quality of life questionnaire (PDQ-39)		Before levodopa infusion and 2 months after levodopa infusion was started	No