Different Dyskinesias in Parkinson's Disease and Their Relation to Levodopa Pharmacokinetics
DYSK-PD-2007
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 parkinson-disease
Started Feb 2008
Shorter than P25 for phase_4 parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 24, 2009
CompletedFirst Posted
Study publicly available on registry
April 27, 2009
CompletedApril 27, 2009
April 1, 2009
3 months
April 24, 2009
April 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Correlation between plasma levodopa concentration and choreatic dyskinesia, dystonia, and parkinsonism
3 days
Secondary Outcomes (1)
Correlation between choreatic dyskinesia, dystonia, and parkinsonism.
3 days
Study Arms (5)
1. Duodopa optimal dose
ACTIVE COMPARATOR2. Duodopa 20% too high dose
EXPERIMENTAL3. Duodopa 10% too low dose
EXPERIMENTAL4. Duodopa 20% too low dose
EXPERIMENTAL5. Duodopa 10% too high dose
EXPERIMENTALInterventions
intestinal gel, for continuous daytime infusion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Treatment with dopamine agonist or glutamate antagonist
- Dementia
- Psychosis
- Treatment with typical neuroleptics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uppsala Universitylead
- Swedish Parkinson's Disease Foundationcollaborator
- Swedish Society for Medical Researchcollaborator
Study Sites (1)
Uppsala University Hospital
Uppsala, 75185, Sweden
Related Publications (1)
Nyholm D, Nilsson Remahl AI, Dizdar N, Constantinescu R, Holmberg B, Jansson R, Aquilonius SM, Askmark H. Duodenal levodopa infusion monotherapy vs oral polypharmacy in advanced Parkinson disease. Neurology. 2005 Jan 25;64(2):216-23. doi: 10.1212/01.WNL.0000149637.70961.4C.
PMID: 15668416BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 24, 2009
First Posted
April 27, 2009
Study Start
February 1, 2008
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
April 27, 2009
Record last verified: 2009-04