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

April 24, 2009 updated by: Uppsala University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, 75185
        • Uppsala University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1. Duodopa optimal dose
Drug: levodopa/carbidopa
intestinal gel, for continuous daytime infusion
Other Names:
  • Duodopa
EXPERIMENTAL: 2. Duodopa 20% too high dose
Drug: levodopa/carbidopa
intestinal gel, for continuous daytime infusion
Other Names:
  • Duodopa
EXPERIMENTAL: 3. Duodopa 10% too low dose
Drug: levodopa/carbidopa
intestinal gel, for continuous daytime infusion
Other Names:
  • Duodopa
EXPERIMENTAL: 4. Duodopa 20% too low dose
Drug: levodopa/carbidopa
intestinal gel, for continuous daytime infusion
Other Names:
  • Duodopa
EXPERIMENTAL: 5. Duodopa 10% too high dose
Drug: levodopa/carbidopa
intestinal gel, for continuous daytime infusion
Other Names:
  • Duodopa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation between plasma levodopa concentration and choreatic dyskinesia, dystonia, and parkinsonism
Time Frame: 3 days
3 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation between choreatic dyskinesia, dystonia, and parkinsonism.
Time Frame: 3 days
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

Swedish Society for Medical Research
Swedish Parkinson's Disease Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (ACTUAL)

May 1, 2008

Study Completion (ACTUAL)

May 1, 2008

Study Registration Dates

First Submitted

April 24, 2009

First Submitted That Met QC Criteria

April 24, 2009

First Posted (ESTIMATE)

April 27, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 27, 2009

Last Update Submitted That Met QC Criteria

April 24, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DYSK-PD-2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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