A Pilot Study of Oxaloacetate in Subjects With Treated PD
NCT ID: NCT01741701
Last Updated: 2016-03-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
33 participants
INTERVENTIONAL
2012-12-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Oxaloacetate (OAA)
active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily
Oxaloacetate (OAA)
Placebo
placebo capsules that contain only 100 mg ascorbate, taken daily
Placebo
Interventions
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Oxaloacetate (OAA)
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of idiopathic PD within 7 years of diagnosis
* Taking stable doses of levodopa and would not predictably need adjustment in PD medications for 4 months
* Unified Parkinson's Disease Rating Scale (UPDRS) II + III at least 30 points at baseline
Exclusion Criteria
* Participation in other drug studies or use of other investigational products within 30 days prior to baseline
* In the Investigator's opinion, any unstable or clinically significant condition that would impair the subjects' ability to comply with study follow-up
* Other known or suspected cause of parkinsonism
30 Years
ALL
No
Sponsors
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Terra Biological LLC
INDUSTRY
University of Kansas Medical Center
OTHER
Responsible Party
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Rajesh Pahwa, MD
Professor, Director PD and Movement Disorder Center
Principal Investigators
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Rajesh Pahwa, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
Countries
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Other Identifiers
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13397
Identifier Type: -
Identifier Source: org_study_id
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