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

April 24, 2009
April 24, 2009
February 2008
May 2008   (final data collection date for primary outcome measure)
Correlation between plasma levodopa concentration and choreatic dyskinesia, dystonia, and parkinsonism [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Correlation between choreatic dyskinesia, dystonia, and parkinsonism. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Different Dyskinesias in Parkinson's Disease and Their Relation to Levodopa Pharmacokinetics
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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Parkinson Disease
  • Dyskinesias
Drug: levodopa/carbidopa
intestinal gel, for continuous daytime infusion
Other Name: Duodopa
  • Active Comparator: 1. Duodopa optimal dose
    Intervention: Drug: levodopa/carbidopa
  • Experimental: 2. Duodopa 20% too high dose
    Intervention: Drug: levodopa/carbidopa
  • Experimental: 3. Duodopa 10% too low dose
    Intervention: Drug: levodopa/carbidopa
  • Experimental: 4. Duodopa 20% too low dose
    Intervention: Drug: levodopa/carbidopa
  • Experimental: 5. Duodopa 10% too high dose
    Intervention: Drug: levodopa/carbidopa
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
30 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00888186
DYSK-PD-2007
Yes
Dag Nyholm, MD, PhD, Uppsala University
Uppsala University
  • Swedish Parkinson's Disease Foundation
  • Swedish Society for Medical Research
Not Provided
Uppsala University
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP