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

This study has been completed.
Swedish Parkinson's Disease Foundation
Swedish Society for Medical Research
Information provided by:
Uppsala University Identifier:
First received: May 19, 2009
Last updated: January 15, 2010
Last verified: January 2010
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.

Condition Intervention Phase
Parkinson Disease
Drug: levodopa/carbidopa
Drug: entacapone
Drug: tolcapone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Levodopa in Patients With Parkinson's Disease Treated With Levodopa/Carbidopa Infusion With and Without Oral COMT Inhibitors

Resource links provided by NLM:

Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in Treatment Response Scale between the treatments. [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: October 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1. Duodopa, optimised dose Drug: levodopa/carbidopa
intestinal gel, continuous infusion (daytime or 24-hour)
Other Name: Duodopa
Experimental: 2. 80% Duodopa + entacapone
80% of optimised Duodopa dose + two tablets of entacapone at t=0 hours and at t= 6 hours
Drug: entacapone
Tablet, 200 mg, given twice during the study at t=0h and t=5hrs
Other Name: Comtess, Comtan.
Experimental: 3. 80% Duodopa + tolcapone
80% of optimised Duodopa dose + two tablets of tolcapone at t=0 hours and at t= 6 hours
Drug: tolcapone
Tablet, 100 mg, given twice during study, at t=0h and t=5hrs.
Other Name: Tasmar

Detailed Description:

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.


Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00906828

Uppsala University Hospital
Uppsala, Sweden, 75646
Sponsors and Collaborators
Uppsala University
Swedish Parkinson's Disease Foundation
Swedish Society for Medical Research
Principal Investigator: Dag Nyholm, MD, PhD Uppsala University
  More Information

Responsible Party: Dag Nyholm, MD, PhD, Uppsala University Identifier: NCT00906828     History of Changes
Other Study ID Numbers: DuoCOMT 
Study First Received: May 19, 2009
Last Updated: January 15, 2010
Health Authority: Sweden: Medical Products Agency

Keywords provided by Uppsala University:
Levodopa/carbidopa infusion

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on February 07, 2016