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Clinical Trials/NCT00888186
NCT00888186
Completed
Phase 4

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

Uppsala University1 site in 1 country5 target enrollmentFebruary 2008

Overview

Phase
Phase 4
Intervention
levodopa/carbidopa
Conditions
Parkinson Disease
Sponsor
Uppsala University
Enrollment
5
Locations
1
Primary Endpoint
Correlation between plasma levodopa concentration and choreatic dyskinesia, dystonia, and parkinsonism
Status
Completed
Last Updated
17 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
February 2008
End Date
May 2008
Last Updated
17 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Uppsala University

Eligibility Criteria

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
  • Psychosis
  • Treatment with typical neuroleptics

Arms & Interventions

1. Duodopa optimal dose

Intervention: levodopa/carbidopa

2. Duodopa 20% too high dose

Intervention: levodopa/carbidopa

3. Duodopa 10% too low dose

Intervention: levodopa/carbidopa

4. Duodopa 20% too low dose

Intervention: levodopa/carbidopa

5. Duodopa 10% too high dose

Intervention: levodopa/carbidopa

Outcomes

Primary Outcomes

Correlation between plasma levodopa concentration and choreatic dyskinesia, dystonia, and parkinsonism

Time Frame: 3 days

Secondary Outcomes

  • Correlation between choreatic dyskinesia, dystonia, and parkinsonism.(3 days)

Study Sites (1)

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