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Natural History of Levodopa-Induced Dyskinesia (LID)

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ClinicalTrials.gov Identifier: NCT01003002
Recruitment Status : Withdrawn (Funding not secured.)
First Posted : October 28, 2009
Last Update Posted : April 6, 2016
Sponsor:
Collaborator:
Oregon Clinical and Translational Research Institute
Information provided by:
Oregon Health and Science University

Brief Summary:
Levodopa is the main drug treatment for Parkinson's disease. Levodopa can cause unwanted and uncontrolled movements called dyskinesias (LID). The severity of these movements can range from subtle to extremely debilitating. These movements may or may not interfere with normal activities such as putting on a coat or brushing ones teeth. Current estimates of the occurrence rate of LID range from 12 % to 100% after one year of levodopa treatment. These estimates used reporting mechanisms such as self-report and doctor-reported. These reporting mechanisms are not reliable. We will use an objective measure of dyskinesia in the first 5 years of treatment for Parkinson's disease. The purpose of this protocol is to use an objective measure to estimate dyskinesia onset.

Condition or disease Intervention/treatment
Parkinson's Disease Drug: Levodopa (delivered intravenously)

Detailed Description:
Nearly all Parkinson's disease (PD) patients eventually develop abnormal and unwanted movements (dyskinesias; LID) caused by the gold standard treatment, Levodopa. The severity of these movements can range from subtle to extremely debilitating and may or may not interfere with normal activities such as putting on a coat or brushing ones teeth. Current estimates of the prevalence of LID widely range from 12 % to 100% affected after one year. The purpose of this study is to estimate the median onset time of levodopa induced dyskinesia in newly treated Parkinson's disease patients. All participants will complete seven overnight visits at the OCTRI Inpatient unit over 5 years. During the next day, participants will complete a mental task while standing on a force plate for one minute every half hour until the end of the study. A levodopa IV infusion will occur from 0900 to 1100.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determining the Natural History of Levodopa-Induced Dyskinesia (LID)
Study Start Date : December 2010
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa

Group/Cohort Intervention/treatment
PD Cohort
The cohort for this study is Parkinson's disease patients that are beginning oral levodopa treatment within one month of the screening visit. This cohort has not previously (to the screening visit) been treated with oral levodopa.
Drug: Levodopa (delivered intravenously)
One mg/kg/hr of Levodopa will be given intravenously during inpatient testing days from 0900 to 1100.




Primary Outcome Measures :
  1. Levodopa-Induced Dyskinesia [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Parkinson's disease
Criteria

Inclusion Criteria:

  • Diagnosis of Parkinson's disease
  • At least 21 years of age
  • Levodopa treatment that will be orally initiated no more than 1 month after the screening visit for the study.

Exclusion Criteria:

  • Unable to stand for 1 minute intervals
  • Sensory deficits in the feet
  • Significant cognitive impairment
  • Unstable medical or psychiatric conditions (including hallucinations)
  • History of dopamine receptor blocking medications (Haldol, Orap, Zyprexa)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01003002


Locations
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United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Oregon Clinical and Translational Research Institute
Investigators
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Principal Investigator: Kathryn Chung, MD Oregon Health and Science University
Publications of Results:
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Responsible Party: Kathryn Chung, MD, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT01003002    
Other Study ID Numbers: e4773
First Posted: October 28, 2009    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: October 2009
Keywords provided by Oregon Health and Science University:
Parkinson's disease
Dyskinesia
Movement Disorders
Additional relevant MeSH terms:
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Parkinson Disease
Dyskinesias
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs