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

Phase 4

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: Levodopa infusion

• Registration Number: NCT00914134
• Lead Sponsor: University of Helsinki

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.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-06-01
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-04
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-23
• Last Update Posted: 2011-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Levodopa Infusion	Levodopa infusion	Patients with advanced Parkinson's disease and motor fluctuations that cannot be adequately controlled with oral medication.

Primary Outcome Measures

Name	Time	Method
Orthostatic blood pressure change	Before levodopa infusion, after 3-5 days of levodopa infusion and 2 months after levodopa infusion was started

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Helsinki University Central Hospital, Department of Neurology; 🇫🇮 Helsinki, Finland