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

Primary Purpose

Parkinson Disease, Dyskinesias

Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
levodopa/carbidopa
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Dyskinesias, Duodenal levodopa infusion, Dose optimization, Pharmacokinetics, Pharmacodynamics

Eligibility Criteria

30 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Uppsala University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

1. Duodopa optimal dose

2. Duodopa 20% too high dose

3. Duodopa 10% too low dose

4. Duodopa 20% too low dose

5. Duodopa 10% too high dose

Arm Description

Outcomes

Primary Outcome Measures

Correlation between plasma levodopa concentration and choreatic dyskinesia, dystonia, and parkinsonism

Secondary Outcome Measures

Correlation between choreatic dyskinesia, dystonia, and parkinsonism.

Full Information

First Posted
April 24, 2009
Last Updated
April 24, 2009
Sponsor
Uppsala University
Collaborators
Swedish Parkinson's Disease Foundation, Swedish Society for Medical Research
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1. Study Identification

Unique Protocol Identification Number
NCT00888186
Brief Title
Different Dyskinesias in Parkinson's Disease and Their Relation to Levodopa Pharmacokinetics
Acronym
DYSK-PD-2007
Official Title
Different Dyskinesias in Parkinson's Disease and Their Relation to Levodopa Pharmacokinetics
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Uppsala University
Collaborators
Swedish Parkinson's Disease Foundation, Swedish Society for Medical Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Dyskinesias
Keywords
Dyskinesias, Duodenal levodopa infusion, Dose optimization, Pharmacokinetics, Pharmacodynamics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1. Duodopa optimal dose
Arm Type
Active Comparator
Arm Title
2. Duodopa 20% too high dose
Arm Type
Experimental
Arm Title
3. Duodopa 10% too low dose
Arm Type
Experimental
Arm Title
4. Duodopa 20% too low dose
Arm Type
Experimental
Arm Title
5. Duodopa 10% too high dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
levodopa/carbidopa
Other Intervention Name(s)
Duodopa
Intervention Description
intestinal gel, for continuous daytime infusion
Primary Outcome Measure Information:
Title
Correlation between plasma levodopa concentration and choreatic dyskinesia, dystonia, and parkinsonism
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Correlation between choreatic dyskinesia, dystonia, and parkinsonism.
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
15668416
Citation
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.
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Different Dyskinesias in Parkinson's Disease and Their Relation to Levodopa Pharmacokinetics

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