Different Dyskinesias in Parkinson's Disease and Their Relation to Levodopa Pharmacokinetics

Study Overview
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Brief Summary
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The purpose of this study is to study different kinds of dyskinesias in advanced Parkinson's disease appearing at different levels of levodopa infusion dose. The hypothesis is that different dyskinesias (dystonia, chorea) correlate to different levels of levodopa concentrations, as detected in plasma.

Detailed Description
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By using duodenal infusion of levodopa/carbidopa, the plasma concentration of levodopa can be kept fairly constant. Different doses, 10-20% higher or lower than the individually optimized dose will be used. Motor performance is captured by video recordings to be compared to/correlated with plasma levodopa concentrations.

Official Title
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Different Dyskinesias in Parkinson's Disease and Their Relation to Levodopa Pharmacokinetics

Conditions
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Parkinson Disease, Dyskinesias

Intervention / Treatment
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* Drug: levodopa/carbidopa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of idiopathic Parkinson's disease Ongoing treatment with Duodopa Occurrence of dyskinesias, difficult to manage Age 30-90 years Hoehn & Yahr stage 3-5 at worst Exclusion Criteria: Treatment with dopamine agonist or glutamate antagonist Dementia Psychosis Treatment with typical neuroleptics

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1. Duodopa optimal dose<br> | Drug: levodopa/carbidopa<br>* intestinal gel, for continuous daytime infusion<br>* Other names: Duodopa;|
| Experimental: 2. Duodopa 20% too high dose<br> | Drug: levodopa/carbidopa<br>* intestinal gel, for continuous daytime infusion<br>* Other names: Duodopa;|
| Experimental: 3. Duodopa 10% too low dose<br> | Drug: levodopa/carbidopa<br>* intestinal gel, for continuous daytime infusion<br>* Other names: Duodopa;|
| Experimental: 4. Duodopa 20% too low dose<br> | Drug: levodopa/carbidopa<br>* intestinal gel, for continuous daytime infusion<br>* Other names: Duodopa;|
| Experimental: 5. Duodopa 10% too high dose<br> | Drug: levodopa/carbidopa<br>* intestinal gel, for continuous daytime infusion<br>* Other names: Duodopa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between plasma levodopa concentration and choreatic dyskinesia, dystonia, and parkinsonism |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between choreatic dyskinesia, dystonia, and parkinsonism. |  | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dyskinesias, Duodenal levodopa infusion, Dose optimization, Pharmacokinetics, Pharmacodynamics