NCT00906828

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

Pharmacokinetics of Levodopa in Patients With Parkinson's Disease Treated With Levodopa/Carbidopa Infusion With and Without Oral COMT Inhibitors

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 30 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	levodopa/carbidopa	intestinal gel, continuous infusion (daytime or 24-hour)
DRUG	entacapone	Tablet, 200 mg, given twice during the study at t=0h and t=5hrs
DRUG	tolcapone	Tablet, 100 mg, given twice during study, at t=0h and t=5hrs.

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2009-05-21
• Last updated: 2010-01-18

Locations

1 site across 1 country: Sweden