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

NCT00914134 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2011-02-24

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Solvay Pharmaceuticals

    collaborator INDUSTRY
  • University of Helsinki

    lead OTHER

Principal Investigators

  • Eero Pekkonen, MD, PhD · Helsinki University Central Hospital, Department of Neurology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • Finland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00914134 on ClinicalTrials.gov