Pharmacokinetics of Levodopa/Carbidopa Infusion With and Without Oral Catechol-O-methyl Transferase (COMT) Inhibitors
DuoCOMT
Pharmacokinetics of Levodopa in Patients With Parkinson's Disease Treated With Levodopa/Carbidopa Infusion With and Without Oral COMT Inhibitors
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 parkinson-disease
Started Oct 2008
Shorter than P25 for phase_4 parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 19, 2009
CompletedFirst Posted
Study publicly available on registry
May 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedJanuary 18, 2010
January 1, 2010
1.1 years
May 19, 2009
January 15, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in coefficient of variation of levodopa in plasma between baseline (day 1) and each of the days on COMT inhibitors.
3 days
Secondary Outcomes (1)
Difference in Treatment Response Scale between the treatments.
3 days
Study Arms (3)
1. Duodopa, optimised dose
ACTIVE COMPARATOR2. 80% Duodopa + entacapone
EXPERIMENTAL80% of optimised Duodopa dose + two tablets of entacapone at t=0 hours and at t= 6 hours
3. 80% Duodopa + tolcapone
EXPERIMENTAL80% of optimised Duodopa dose + two tablets of tolcapone at t=0 hours and at t= 6 hours
Interventions
intestinal gel, continuous infusion (daytime or 24-hour)
Tablet, 200 mg, given twice during the study at t=0h and t=5hrs
Tablet, 100 mg, given twice during study, at t=0h and t=5hrs.
Eligibility Criteria
You may qualify if:
- Parkinson's disease
- Duodopa treatment ongoing
- Hoehn \& Yahr stage 3-5 at worst
You may not qualify if:
- Ongoing treatment with COMT inhibitors
- Dementia
- Psychosis
- Treatment with typical neuroleptics
- Contraindications for entacapone or tolcapone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uppsala Universitylead
- Swedish Parkinson's Disease Foundationcollaborator
- Swedish Society for Medical Researchcollaborator
Study Sites (1)
Uppsala University Hospital
Uppsala, 75646, Sweden
Related Publications (1)
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.
PMID: 17078781BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dag Nyholm, MD, PhD
Uppsala University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 19, 2009
First Posted
May 21, 2009
Study Start
October 1, 2008
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
January 18, 2010
Record last verified: 2010-01