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

January 15, 2010 updated by: Uppsala University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, 75646
        • Uppsala University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference in Treatment Response Scale between the treatments.
Time Frame: 3 days
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

Swedish Society for Medical Research
Swedish Parkinson's Disease Foundation

Investigators

  • Principal Investigator: Dag Nyholm, MD, PhD, Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

May 19, 2009

First Submitted That Met QC Criteria

May 20, 2009

First Posted (Estimate)

May 21, 2009

Study Record Updates

Last Update Posted (Estimate)

January 18, 2010

Last Update Submitted That Met QC Criteria

January 15, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DuoCOMT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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