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| Name | Class |
|---|---|
| Swedish Parkinson's Disease Foundation | UNKNOWN |
| Swedish Society for Medical Research | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Duodopa, optimised dose | Active Comparator |
| |
| 2. 80% Duodopa + entacapone | Experimental | 80% of optimised Duodopa dose + two tablets of entacapone at t=0 hours and at t= 6 hours |
|
| 3. 80% Duodopa + tolcapone | Experimental | 80% of optimised Duodopa dose + two tablets of tolcapone at t=0 hours and at t= 6 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levodopa/carbidopa | Drug | intestinal gel, continuous infusion (daytime or 24-hour) |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Treatment Response Scale between the treatments. | 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dag Nyholm, MD, PhD | Uppsala University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uppsala University Hospital | Uppsala | 75646 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17078781 | Background | 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. doi: 10.1586/14737175.6.10.1403. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C009265 | carbidopa, levodopa drug combination |
| C071192 | entacapone |
| D000077867 | Tolcapone |
| ID | Term |
|---|---|
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| entacapone | Drug | Tablet, 200 mg, given twice during the study at t=0h and t=5hrs |
|
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| tolcapone | Drug | Tablet, 100 mg, given twice during study, at t=0h and t=5hrs. |
|
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D009596 | Nitrophenols |
| D010636 | Phenols |
| D007659 | Ketones |
| D009574 | Nitro Compounds |