Pharmacokinetics of Levodopa/Carbidopa Infusion With and Without Oral Catechol-O-methyl Transferase (COMT) Inhibitors (DuoCOMT)
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.
|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|
- 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 ]
- Difference in Treatment Response Scale between the treatments. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
|Active Comparator: 1. Duodopa, optimised dose||
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
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
Tablet, 100 mg, given twice during study, at t=0h and t=5hrs.
Other Name: Tasmar
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00906828
|Uppsala University Hospital|
|Uppsala, Sweden, 75646|
|Principal Investigator:||Dag Nyholm, MD, PhD||Uppsala University|