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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:
Collaborators:
Swedish Parkinson's Disease Foundation
Swedish Society for Medical Research
Information provided by:
Uppsala University
ClinicalTrials.gov Identifier:
NCT00888186
First received: April 24, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Different Dyskinesias in Parkinson's Disease and Their Relation to Levodopa Pharmacokinetics

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation between choreatic dyskinesia, dystonia, and parkinsonism. [ Time Frame: 3 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: April 24, 2009
Last Updated: April 24, 2009
Health Authority: Sweden: Medical Products Agency

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

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

ClinicalTrials.gov processed this record on May 19, 2013