Pharmacokinetics of Levodopa/Carbidopa Infusion With and Without Oral Catechol-O-methyl Transferase (COMT) Inhibitors (DuoCOMT)
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
levodopa/carbidopa
entacapone
tolcapone
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Levodopa/carbidopa infusion, entacapone, tolcapone, efficacy, pharmacokinetic, pharmacodynamics
Eligibility 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
Sites / Locations
- Uppsala University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
1. Duodopa, optimised dose
2. 80% Duodopa + entacapone
3. 80% Duodopa + tolcapone
Arm Description
80% of optimised Duodopa dose + two tablets of entacapone at t=0 hours and at t= 6 hours
80% of optimised Duodopa dose + two tablets of tolcapone at t=0 hours and at t= 6 hours
Outcomes
Primary Outcome Measures
Difference in coefficient of variation of levodopa in plasma between baseline (day 1) and each of the days on COMT inhibitors.
Secondary Outcome Measures
Difference in Treatment Response Scale between the treatments.
Full Information
NCT ID
NCT00906828
First Posted
May 19, 2009
Last Updated
January 15, 2010
Sponsor
Uppsala University
Collaborators
Swedish Parkinson's Disease Foundation, Swedish Society for Medical Research
1. Study Identification
Unique Protocol Identification Number
NCT00906828
Brief Title
Pharmacokinetics of Levodopa/Carbidopa Infusion With and Without Oral Catechol-O-methyl Transferase (COMT) Inhibitors
Acronym
DuoCOMT
Official Title
Pharmacokinetics of Levodopa in Patients With Parkinson's Disease Treated With Levodopa/Carbidopa Infusion With and Without Oral COMT Inhibitors
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Uppsala University
Collaborators
Swedish Parkinson's Disease Foundation, Swedish Society for Medical Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Levodopa/carbidopa infusion, entacapone, tolcapone, efficacy, pharmacokinetic, pharmacodynamics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1. Duodopa, optimised dose
Arm Type
Active Comparator
Arm Title
2. 80% Duodopa + entacapone
Arm Type
Experimental
Arm Description
80% of optimised Duodopa dose + two tablets of entacapone at t=0 hours and at t= 6 hours
Arm Title
3. 80% Duodopa + tolcapone
Arm Type
Experimental
Arm Description
80% of optimised Duodopa dose + two tablets of tolcapone at t=0 hours and at t= 6 hours
Intervention Type
Drug
Intervention Name(s)
levodopa/carbidopa
Other Intervention Name(s)
Duodopa
Intervention Description
intestinal gel, continuous infusion (daytime or 24-hour)
Intervention Type
Drug
Intervention Name(s)
entacapone
Other Intervention Name(s)
Comtess, Comtan.
Intervention Description
Tablet, 200 mg, given twice during the study at t=0h and t=5hrs
Intervention Type
Drug
Intervention Name(s)
tolcapone
Other Intervention Name(s)
Tasmar
Intervention Description
Tablet, 100 mg, given twice during study, at t=0h and t=5hrs.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Difference in Treatment Response Scale between the treatments.
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dag Nyholm, MD, PhD
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
75646
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
17078781
Citation
Nyholm D. Enteral levodopa/carbidopa gel infusion for the treatment of motor fluctuations and dyskinesias in advanced Parkinson's disease. Expert Rev Neurother. 2006 Oct;6(10):1403-11. doi: 10.1586/14737175.6.10.1403.
Results Reference
background
Learn more about this trial
Pharmacokinetics of Levodopa/Carbidopa Infusion With and Without Oral Catechol-O-methyl Transferase (COMT) Inhibitors
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