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

NCT ID: NCT00914134

Last Updated: 2011-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2011-01-31

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Levodopa Infusion

Patients with advanced Parkinson's disease and motor fluctuations that cannot be adequately controlled with oral medication.

Group Type: EXPERIMENTAL

Levodopa infusion

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Duodopa

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Solvay Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

University of Helsinki

OTHER

Sponsor Role: lead

Responsible Party

Helsinki University Central Hospital, Department of Neurology

Principal Investigators

Eero Pekkonen, MD, PhD

Role: STUDY_DIRECTOR

Helsinki University Central Hospital, Department of Neurology

Locations

Helsinki University Central Hospital, Department of Neurology

Helsinki, , Finland

Countries

Finland

Other Identifiers

PDAUT2009

Identifier Type: -

Identifier Source: org_study_id