Trial | NCT00888186  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    5
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.
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.
Study Started
Feb 29
2008
Primary Completion
May 31
2008
Study Completion
May 31
2008
Last Update
Apr 27
2009
Estimate

Drug levodopa/carbidopa

intestinal gel, for continuous daytime infusion

  • Other names: Duodopa

1. Duodopa optimal dose Active Comparator

2. Duodopa 20% too high dose Experimental

3. Duodopa 10% too low dose Experimental

4. Duodopa 20% too low dose Experimental

5. Duodopa 10% too high dose Experimental

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
Dementia
Psychosis
Treatment with typical neuroleptics
No Results Posted