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

NCT ID: NCT00888186

Last Updated: 2009-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-05-31

Brief Summary

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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

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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.

Conditions

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Parkinson Disease Dyskinesias

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1. Duodopa optimal dose

Group Type ACTIVE_COMPARATOR

levodopa/carbidopa

Intervention Type DRUG

intestinal gel, for continuous daytime infusion

2. Duodopa 20% too high dose

Group Type EXPERIMENTAL

levodopa/carbidopa

Intervention Type DRUG

intestinal gel, for continuous daytime infusion

3. Duodopa 10% too low dose

Group Type EXPERIMENTAL

levodopa/carbidopa

Intervention Type DRUG

intestinal gel, for continuous daytime infusion

4. Duodopa 20% too low dose

Group Type EXPERIMENTAL

levodopa/carbidopa

Intervention Type DRUG

intestinal gel, for continuous daytime infusion

5. Duodopa 10% too high dose

Group Type EXPERIMENTAL

levodopa/carbidopa

Intervention Type DRUG

intestinal gel, for continuous daytime infusion

Interventions

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levodopa/carbidopa

intestinal gel, for continuous daytime infusion

Intervention Type DRUG

Other Intervention Names

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Duodopa

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swedish Parkinson's Disease Foundation

UNKNOWN

Sponsor Role collaborator

Swedish Society for Medical Research

OTHER

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Uppsala University

Locations

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Uppsala University Hospital

Uppsala, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 15668416 (View on PubMed)

Other Identifiers

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DYSK-PD-2007

Identifier Type: -

Identifier Source: org_study_id

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