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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00906828

Acronym

DuoCOMT

Enrollment

Registered

2009-05-21

Start date

2008-10-31

Completion date

2009-11-30

Last updated

2010-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Levodopa/carbidopa infusion, entacapone, tolcapone, efficacy, pharmacokinetic, pharmacodynamics

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.

Interventions

DRUGlevodopa/carbidopa

intestinal gel, continuous infusion (daytime or 24-hour)

DRUGentacapone

Tablet, 200 mg, given twice during the study at t=0h and t=5hrs

DRUGtolcapone

Tablet, 100 mg, given twice during study, at t=0h and t=5hrs.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Difference in Treatment Response Scale between the treatments.	3 days

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026