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

Parkinson Disease Clinical Trial

— DuoCOMT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00906828
• Other study ID #: DuoCOMT
• Status: Completed
• Phase: Phase 4
• First received: May 19, 2009
• Last updated: January 15, 2010
• Start date: October 2008
• Est. completion date: November 2009

Study information

• Verified date: January 2010
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital	Uppsala

Sponsors (3)

Lead Sponsor	Collaborator
Uppsala University	Swedish Parkinson's Disease Foundation, Swedish Society for Medical Research

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Nyholm D. Enteral levodopa/carbidopa gel infusion for the treatment of motor fluctuations and dyskinesias in advanced Parkinson's disease. Expert Rev Neurother. 2006 Oct;6(10):1403-11. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in coefficient of variation of levodopa in plasma between baseline (day 1) and each of the days on COMT inhibitors.		3 days	No
Secondary	Difference in Treatment Response Scale between the treatments.		3 days	No