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

Phase 4

Completed

• Conditions: Parkinson Disease
• Interventions: Drug: levodopa/carbidopa; Drug: entacapone; Drug: tolcapone

• Registration Number: NCT00906828
• Lead Sponsor: Uppsala University

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-05-19
• Study First Submitted QC: 2009-05-20
• Study First Posted: 2009-05-21
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-15
• Last Update Posted: 2010-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1. Duodopa, optimised dose	levodopa/carbidopa	-
2. 80% Duodopa + entacapone	entacapone	80% of optimised Duodopa dose + two tablets of entacapone at t=0 hours and at t= 6 hours
3. 80% Duodopa + tolcapone	tolcapone	80% of optimised Duodopa dose + two tablets of tolcapone at t=0 hours and at t= 6 hours

Primary Outcome Measures

Name	Time	Method
Difference in coefficient of variation of levodopa in plasma between baseline (day 1) and each of the days on COMT inhibitors.	3 days

Secondary Outcome Measures

Name	Time	Method
Difference in Treatment Response Scale between the treatments.	3 days

Trial Locations

Locations (1)

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden