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Pharmacokinetics of Levodopa/Carbidopa Infusion With and Without Oral Catechol-O-methyl Transferase (COMT) Inhibitors

NCT00906828 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2010-01-18

No results posted yet for this study

Summary

The purpose of this study is to determine whether oral intake of COMT inhibitors affects the smooth plasma levodopa levels achieved by intestinal levodopa/carbidopa infusion in advanced Parkinson's disease patients. The hypothesis is that COMT inhibitors make plasma concentrations of levodopa more fluctuating.

Conditions

  • Parkinson Disease

Interventions

DRUG

levodopa/carbidopa

intestinal gel, continuous infusion (daytime or 24-hour)

DRUG

entacapone

Tablet, 200 mg, given twice during the study at t=0h and t=5hrs

DRUG

tolcapone

Tablet, 100 mg, given twice during study, at t=0h and t=5hrs.

Sponsors & Collaborators

  • Swedish Parkinson's Disease Foundation

    collaborator UNKNOWN

  • Swedish Society for Medical Research

    collaborator OTHER

  • Uppsala University

    lead OTHER

Principal Investigators

  • Dag Nyholm, MD, PhD · Uppsala University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • Sweden

Study Locations

More Related Trials

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 NCT00906828 on ClinicalTrials.gov