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Completed

NCT Number: NCT00888186

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dyskinesias Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Uppsala University Hospital

Uppsala, 75185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levodopa/carbidopa

Drug

intestinal gel, for continuous daytime infusion

Other names: Duodopa

Primary outcomes

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

    Time frame: 3 days

Secondary outcomes

  1. Correlation between choreatic dyskinesia, dystonia, and parkinsonism.

    Time frame: 3 days

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Swedish Parkinson's Disease Foundation
  • Swedish Society for Medical Research

Registry information

Acronym: DYSK-PD-2007

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 27, 2009
Registry last updated
Apr 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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