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Different Dyskinesias in Parkinson's Disease and Their Relation to Levodopa Pharmacokinetics (DYSK-PD-2007)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00888186
First Posted: April 27, 2009
Last Update Posted: April 27, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Swedish Parkinson's Disease Foundation
Swedish Society for Medical Research
Information provided by:
Uppsala University
  Purpose
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.

Condition Intervention Phase
Parkinson Disease Dyskinesias Drug: levodopa/carbidopa Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Different Dyskinesias in Parkinson's Disease and Their Relation to Levodopa Pharmacokinetics

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Correlation between plasma levodopa concentration and choreatic dyskinesia, dystonia, and parkinsonism [ Time Frame: 3 days ]

Secondary Outcome Measures:
  • Correlation between choreatic dyskinesia, dystonia, and parkinsonism. [ Time Frame: 3 days ]

Enrollment: 5
Study Start Date: February 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1. Duodopa optimal dose Drug: levodopa/carbidopa
intestinal gel, for continuous daytime infusion
Other Name: Duodopa
Experimental: 2. Duodopa 20% too high dose Drug: levodopa/carbidopa
intestinal gel, for continuous daytime infusion
Other Name: Duodopa
Experimental: 3. Duodopa 10% too low dose Drug: levodopa/carbidopa
intestinal gel, for continuous daytime infusion
Other Name: Duodopa
Experimental: 4. Duodopa 20% too low dose Drug: levodopa/carbidopa
intestinal gel, for continuous daytime infusion
Other Name: Duodopa
Experimental: 5. Duodopa 10% too high dose Drug: levodopa/carbidopa
intestinal gel, for continuous daytime infusion
Other Name: Duodopa

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00888186


Locations
Sweden
Uppsala University Hospital
Uppsala, Sweden, 75185
Sponsors and Collaborators
Uppsala University
Swedish Parkinson's Disease Foundation
Swedish Society for Medical Research
  More Information

Publications:
Responsible Party: Dag Nyholm, MD, PhD, Uppsala University
ClinicalTrials.gov Identifier: NCT00888186     History of Changes
Other Study ID Numbers: DYSK-PD-2007
First Submitted: April 24, 2009
First Posted: April 27, 2009
Last Update Posted: April 27, 2009
Last Verified: April 2009

Keywords provided by Uppsala University:
Dyskinesias
Duodenal levodopa infusion
Dose optimization
Pharmacokinetics
Pharmacodynamics

Additional relevant MeSH terms:
Parkinson Disease
Dyskinesias
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Levodopa
Carbidopa
Carbidopa, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists