Intravenous Levodopa for the Diagnosis of Parkinson's Disease

NCT ID: NCT00001928

Last Updated: 2008-03-04

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

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-03-31

Study Completion Date

2000-07-31

Brief Summary

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Patients with Parkinson's disease have low levels of the neurotransmitter dopamine. Dopamine is responsible for motor function and normal physical activity. Patients with Parkinson's disease typically suffer from tremors, rigid muscles, stooped postures, and walk with a shuffle. The drug levodopa acts as a replacement for dopamine and has been has been used effectively for over 30 years as treatment for Parkinsons disease. Because of its effectiveness, levodopa has been used to distinguish Parkinson's disease from other conditions that may resemble Parkinson's disease.

Traditionally, levodopa has been given as a pill. In this study, researchers would like to inject levodopa directly into a vein (intravenous) in order to diagnose cases of Parkinson's disease. This method provides immediate results and allows doctors to adjust the dose of levodopa very carefully. Because the intravenous method of giving levodopa is less practical than oral medication, it is not an available alternative for the routine treatment of Parkinson's disease. However, it may be useful for faster diagnosis of the disease and for determining effective doses of oral medication.

Detailed Description

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A positive response to levodopa is now considered a condition sine qua non for the diagnosis of idiopathic Parkinson's disease. Under this protocol, patients with parkinsonism of uncertain etiology will be tested for their motor response to intravenous levodopa to aid in the diagnosis of Parkinson's disease. This protocol regulates and stipulates the acute administration of intravenous levodopa and associated safety issues.

Conditions

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Parkinson Disease

Eligibility Criteria

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Inclusion Criteria

No presence or history of any medical condition that can reasonably be expected to subject the patient to unwarranted risks, specifically those who have the following: a history of convulsive, hepatic, or renal disorders; currently receiving treatment for myocardial infarction, arrhythmia or cardiac failure; and pregnant women or anyone not practicing an effective means of birth control.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role lead

Locations

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National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, United States

Site Status

Countries

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United States

References

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Fabbrini G, Juncos J, Mouradian MM, Serrati C, Chase TN. Levodopa pharmacokinetic mechanisms and motor fluctuations in Parkinson's disease. Ann Neurol. 1987 Apr;21(4):370-6. doi: 10.1002/ana.410210409.

Reference Type BACKGROUND
PMID: 3579222 (View on PubMed)

Mouradian MM, Juncos JL, Fabbrini G, Chase TN. Motor fluctuations in Parkinson's disease: pathogenetic and therapeutic studies. Ann Neurol. 1987 Oct;22(4):475-9. doi: 10.1002/ana.410220406.

Reference Type BACKGROUND
PMID: 3435068 (View on PubMed)

Fabbrini G, Mouradian MM, Juncos JL, Schlegel J, Mohr E, Chase TN. Motor fluctuations in Parkinson's disease: central pathophysiological mechanisms, Part I. Ann Neurol. 1988 Sep;24(3):366-71. doi: 10.1002/ana.410240303.

Reference Type BACKGROUND
PMID: 3228270 (View on PubMed)

Other Identifiers

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99-N-0072

Identifier Type: -

Identifier Source: secondary_id

990072

Identifier Type: -

Identifier Source: org_study_id

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