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

Sponsor

Uppsala University (Other)

Overall Status

Completed

CT.gov ID

NCT00906828

Collaborator

Swedish Parkinson's Disease Foundation (Other), Swedish Society for Medical Research (Other)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Drug: levodopa/carbidopa Drug: entacapone Drug: tolcapone	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (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

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Nov 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1. Duodopa, optimised dose	Drug: levodopa/carbidopa intestinal gel, continuous infusion (daytime or 24-hour) Other Names: Duodopa
Experimental: 2. 80% Duodopa + entacapone 80% of optimised Duodopa dose + two tablets of entacapone at t=0 hours and at t= 6 hours	Drug: entacapone Tablet, 200 mg, given twice during the study at t=0h and t=5hrs Other Names: 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	Drug: tolcapone Tablet, 100 mg, given twice during study, at t=0h and t=5hrs. Other Names: Tasmar

Arm

Intervention/Treatment

Active Comparator: 1. Duodopa, optimised dose

Drug: levodopa/carbidopa

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

Other Names:

Duodopa

Experimental: 2. 80% Duodopa + entacapone

80% of optimised Duodopa dose + two tablets of entacapone at t=0 hours and at t= 6 hours

Drug: entacapone

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

Other Names: