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Natural History of Levodopa-Induced Dyskinesia (LID)

Determining the Natural History of Levodopa-Induced Dyskinesia (LID)

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01003002
Enrollment
0
Registered
2009-10-28
Start date
2010-12-31
Completion date
2020-12-31
Last updated
2016-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Parkinson's disease, Dyskinesia, Movement Disorders

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.

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.

Interventions

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

Sponsors

Oregon Clinical and Translational Research Institute
CollaboratorOTHER
Oregon Health and Science University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Levodopa-Induced Dyskinesia5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026