Measuring Parkinson's Disease Progression (MPDP)
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|ClinicalTrials.gov Identifier: NCT03205956|
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : March 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Drug: Levodopa||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All participants receive oral carbidopa before, and i.v. levodopa during brain imaging, to measure regional cerebral blood flow responses to levodopa.|
|Masking:||None (Open Label)|
|Official Title:||Dopamine Buffering Capacity Measured by phMRI as a Novel Biomarker of Disease Progression in PD|
|Actual Study Start Date :||October 19, 2017|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||September 30, 2019|
Experimental: PD Group
A broad range of Parkinson's disease severity and disease duration. Some subjects will not be treated currently with levodopa, and thus likely will be early in the disease process.
At least 1 hour after 200mg carbidopa p.o., each subject will receive an intravenous solution of levodopa in saline at a rate based on age and body mass according to the "final dose" described in Black et al 2003.The total dose for a 70-year-old, 70kg subject will be approximately 65mg.
Subjects with untreated PD will then take 6 ± 1 weeks of clinically dosed oral carbidopa-levodopa tablets for clinical purposes and then repeat the carbidopa plus intravenous levodopa dose as above.
Other Name: Carbidopa
- Ke measured by phMRI [ Time Frame: 2 hours ]Effect site rate constant measured by serum levodopa concentrations and regional cerebral blood flow. Note, there are no outcome measures relevant to clinical care. This is not a placebo-controlled treatment study.
- Side effect ratings [ Time Frame: 2 hours ]Nausea/vomiting, sleepiness, dizziness or lightheadedness, and overall feeling poorly or well, are each measured on a horizontal visual analog scale before and at the end of the i.v. levodopa infusion
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): NCT03205956
|Contact: Kevin J Black, MD||3143625041||kevin@WUSTL.edu|
|Contact: Emily C Bihun, M.Ed.||firstname.lastname@example.org|
|United States, Missouri|
|Washington University School of Medicine, Movement Disorders Center||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Emily C. Bihun, M.Ed. 314-362-2083 EmilyBihun@wustl.edu|
|Contact: Kevin J Black, MD 314-362-5041 kevin@WUSTL.edu|
|Principal Investigator: Kevin J. Black, MD|
|Principal Investigator:||Kevin J Black, MD||Washington University School of Medicine|