CClinicalTrials.gg
CompletedNCT00888186DYSK-PD-2007Updated Apr 27, 2009

Different Dyskinesias in Parkinson's Disease and Their Relation to Levodopa Pharmacokinetics

A Phase 4 interventional study of levodopa/carbidopa in Parkinson Disease and Dyskinesias, sponsored by Uppsala University. Completed at 1 site in Sweden. Open to participants aged 30 Years to 90 Years. Per ClinicalTrials.gov, last updated 2009-04-27.

Sponsored by Uppsala University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
5
Allocation
Non-randomized
Ages
30 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Parkinson Disease
  • Dyskinesias

Keywords

  • Dyskinesias
  • Duodenal levodopa infusion
  • Dose optimization
  • Pharmacokinetics
  • Pharmacodynamics
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 5 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Uppsala University is the lead sponsor of 381 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Treatment with dopamine agonist or glutamate antagonist
  • Dementia
  • Psychosis
  • Treatment with typical neuroleptics
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
Double (Participant, Outcomes assessor)
Enrollment
5 participants (actual)

Study arms

  • Active comparator
    1. Duodopa optimal dose

    Drug: levodopa/carbidopa

  • Experimental
    2. Duodopa 20% too high dose

    Drug: levodopa/carbidopa

  • Experimental
    3. Duodopa 10% too low dose

    Drug: levodopa/carbidopa

  • Experimental
    4. Duodopa 20% too low dose

    Drug: levodopa/carbidopa

  • Experimental
    5. Duodopa 10% too high dose

    Drug: levodopa/carbidopa

Interventions

  • Druglevodopa/carbidopa

    intestinal gel, for continuous daytime infusion

    Also known as: Duodopa

06

What researchers measure

Primary outcomes

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

    Time frame: 3 days

Secondary outcomes

  1. Correlation between choreatic dyskinesia, dystonia, and parkinsonism.

    Time frame: 3 days

07

Study locations

1 site
  • Uppsala University Hospital
    Uppsala, 75185, Sweden
08

References and documents

Publications

  • 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. PubMed 15668416 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00888186
Lead sponsor
Uppsala University
Collaborators
Swedish Parkinson's Disease Foundation, Swedish Society for Medical Research
First posted
Apr 27, 2009
Start date
Feb 2008
Primary completion
May 2008
Completion
May 2008
Last update
Apr 27, 2009

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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