Parkinson DiseaseNCT00001928
Intravenous Levodopa for the Diagnosis of Parkinson's Disease
An observational study of Parkinson Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1999to Jul 2000
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
All patients will have parkinsonism of undetermined etiology.
Males and females between the ages of 18 and 85 are eligible for the study.
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Intravenous Levodopa in Parkinsonism
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.
Read the detailed description
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
- Parkinson Disease
- Keywords
- Diagnosis, Infusion, Parkinsonism
- Medical subject headings
- Parkinson Disease, Disease, Parkinsonian Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startMar 1999
- Study completionJul 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 25 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001928
- Sponsor's protocol ID
- 990072
- Other IDs
- 99-N-0072
- Status last verified
- Mar 1999
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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.
PubMed 3579222Mouradian 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.
PubMed 3435068Fabbrini 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.
PubMed 3228270
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Levodopa in Parkinsonism
- ClinicalTrials.gov ID
- NCT00001928
- Acronym / sponsor ID
- 990072
- Conditions
- Parkinson Disease
- Keywords
- Diagnosis, Infusion, Parkinsonism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Mar 1999
- Study completion
- Jul 2000
- First posted
- 10 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 3579222Fabbrini 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.
- Background: PubMed 3435068Mouradian 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.
- Background: PubMed 3228270Fabbrini 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001928, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.