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

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ClinicalTrials.gov Identifier: NCT00888186
Recruitment Status : Completed
First Posted : April 27, 2009
Last Update Posted : April 27, 2009
Sponsor:
Collaborators:
Swedish Parkinson's Disease Foundation
Swedish Society for Medical Research
Information provided by:
Uppsala University

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.

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
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
Study Start Date : February 2008
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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

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


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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

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

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