NCT00914134

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

February 24, 2011

Status Verified

February 1, 2011

Enrollment Period

1.8 years

First QC Date

June 1, 2009

Last Update Submit

February 23, 2011

Conditions

Parkinson's Disease

Keywords

Parkinson's diseaseAutonomic nervous systemLevodopa infusion

Outcome Measures

Primary Outcomes (1)

  • Orthostatic blood pressure change

    Before levodopa infusion, after 3-5 days of levodopa infusion and 2 months after levodopa infusion was started

Secondary Outcomes (3)

  • 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

Study Arms (1)

Levodopa Infusion

EXPERIMENTAL

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

Drug: Levodopa infusion

Interventions

Levodopa infusionDRUG

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.

Also known as: Duodopa
Levodopa Infusion

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Severe cognitive symptoms
  • Glaucoma
  • Severe arrythmias
  • Severe asthma or COPD
  • Heart, liver or kidney failure
  • No significant vascular lesions in brain MRI imaging.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Central Hospital, Department of Neurology

Helsinki, 00250, Finland

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

carbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Eero Pekkonen, MD, PhD

    Helsinki University Central Hospital, Department of Neurology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 1, 2009

First Posted

June 4, 2009

Study Start

April 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

February 24, 2011

Record last verified: 2011-02

Locations

FI(1)