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Completed

NCT Number: NCT00906828

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Uppsala University Hospital

Uppsala, 75646, Sweden

About this study

The aim is to measure variability in plasma levodopa levels during the following three treatments:

Day 1: Duodopa in individually optimised dose Day 2: 80% of optimised Duodopa dose + two tablets of entacapone at t=0 hours and at t= 6 hours Day 3: 80% of optimised Duodopa dose + two tablets of tolcapone at t=0 hours and at t= 6 hours Plasma samples for determination of levodopa concentrations will be taken every 30 minutes during 8 hours. Video recordings will be performed every 30 min during 8 hours, for later blinded assessments by 2-3 experts. Sequences will be in randomised order. Patient self-scores regarding mobility will be recorded, every 30 min during 8 hours.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parkinson's disease
  • Duodopa treatment ongoing
  • Hoehn & Yahr stage 3-5 at worst

Exclusion criteria

  • Ongoing treatment with COMT inhibitors
  • Dementia
  • Psychosis
  • Treatment with typical neuroleptics
  • Contraindications for entacapone or tolcapone

Treatment and study plan

Levodopa/carbidopa

Drug

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

Other names: Duodopa

Entacapone

Drug

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

Other names: Comtess, Comtan.

Tolcapone

Drug

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

Other names: Tasmar

Primary outcomes

  1. Difference in coefficient of variation of levodopa in plasma between baseline (day 1) and each of the days on COMT inhibitors.

    Time frame: 3 days

Secondary outcomes

  1. Difference in Treatment Response Scale between the treatments.

    Time frame: 3 days

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Swedish Parkinson's Disease Foundation
  • Swedish Society for Medical Research

Registry information

Official study title

Pharmacokinetics of Levodopa in Patients With Parkinson's Disease Treated With Levodopa/Carbidopa Infusion With and Without Oral COMT Inhibitors

Acronym: DuoCOMT

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 21, 2009
Registry last updated
Jan 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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