Pharmacokinetics of Levodopa/Carbidopa Infusion With and Without Oral Catechol-O-methyl Transferase (COMT) Inhibitors (DuoCOMT)
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ClinicalTrials.gov Identifier: NCT00906828 |
Recruitment Status :
Completed
First Posted : May 21, 2009
Last Update Posted : January 18, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson Disease | Drug: levodopa/carbidopa Drug: entacapone Drug: tolcapone | Phase 4 |
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 (Clinical Trial) |
Estimated 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 : | October 2008 |
Actual Primary Completion Date : | November 2009 |
Actual Study Completion Date : | November 2009 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1. Duodopa, optimised dose |
Drug: levodopa/carbidopa
intestinal gel, continuous infusion (daytime or 24-hour)
Other Name: Duodopa |
Experimental: 2. 80% Duodopa + entacapone
80% of optimised Duodopa dose + two tablets of entacapone at t=0 hours and at t= 6 hours
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Drug: entacapone
Tablet, 200 mg, given twice during the study at t=0h and t=5hrs
Other Name: 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 Name: Tasmar |
- 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 ]
- Difference in Treatment Response Scale between the treatments. [ Time Frame: 3 days ]

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Ages Eligible for Study: | 30 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00906828
Sweden | |
Uppsala University Hospital | |
Uppsala, Sweden, 75646 |
Principal Investigator: | Dag Nyholm, MD, PhD | Uppsala University |
Responsible Party: | Dag Nyholm, MD, PhD, Uppsala University |
ClinicalTrials.gov Identifier: | NCT00906828 |
Other Study ID Numbers: |
DuoCOMT |
First Posted: | May 21, 2009 Key Record Dates |
Last Update Posted: | January 18, 2010 |
Last Verified: | January 2010 |
Levodopa/carbidopa infusion entacapone tolcapone |
efficacy pharmacokinetic pharmacodynamics |
Entacapone Tolcapone Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Levodopa |
Carbidopa Antiparkinson Agents Anti-Dyskinesia Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Aromatic Amino Acid Decarboxylase Inhibitors Enzyme Inhibitors Catechol O-Methyltransferase Inhibitors |