Natural History of Levodopa-Induced Dyskinesia (LID)

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Parkinson's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Levodopa (delivered intravenously)

Intervention Type DRUG

One mg/kg/hr of Levodopa will be given intravenously during inpatient testing days from 0900 to 1100.

Interventions

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Levodopa (delivered intravenously)

One mg/kg/hr of Levodopa will be given intravenously during inpatient testing days from 0900 to 1100.

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

21 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No