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

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ClinicalTrials.gov Identifier: NCT00906828
Recruitment Status : Completed
First Posted : May 21, 2009
Last Update Posted : January 18, 2010
Sponsor:
Collaborators:
Swedish Parkinson's Disease Foundation
Swedish Society for Medical Research
Information provided by:
Uppsala University

Study Description
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Brief 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.

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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (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
Study Start Date : October 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Difference in Treatment Response Scale between the treatments. [ Time Frame: 3 days ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00906828


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

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Responsible Party: Dag Nyholm, MD, PhD, Uppsala University
ClinicalTrials.gov Identifier: NCT00906828    
Other Study ID Numbers: DuoCOMT
First Posted: May 21, 2009    Key Record Dates
Last Update Posted: January 18, 2010
Last Verified: January 2010
Keywords provided by Uppsala University:
Levodopa/carbidopa infusion
entacapone
tolcapone
 efficacy
pharmacokinetic
pharmacodynamics
Additional relevant MeSH terms:
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Entacapone
Tolcapone
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
 Carbidopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Catechol O-Methyltransferase Inhibitors