A Pilot Study of Oxaloacetate in Subjects With Treated PD
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ClinicalTrials.gov Identifier: NCT01741701 |
Recruitment Status :
Completed
First Posted : December 5, 2012
Results First Posted : March 17, 2016
Last Update Posted : March 17, 2016
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Sponsor:
University of Kansas Medical Center
Collaborator:
Terra Biological LLC
Information provided by (Responsible Party):
Rajesh Pahwa, MD, University of Kansas Medical Center
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
Parkinson's Disease |
Interventions |
Drug: Oxaloacetate (OAA) Drug: Placebo |
Enrollment | 33 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Oxaloacetate (OAA) | Placebo |
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active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily Oxaloacetate (OAA) |
placebo capsules that contain only 100 mg ascorbate, taken daily Placebo |
Period Title: Overall Study | ||
Started | 18 | 15 |
Completed | 13 | 13 |
Not Completed | 5 | 2 |
Reason Not Completed | ||
Adverse Event | 5 | 1 |
Withdrawal by Subject | 0 | 1 |
Baseline Characteristics
Arm/Group Title | Oxaloacetate (OAA) | Placebo | Total | |
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active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily Oxaloacetate (OAA) |
placebo capsules that contain only 100 mg ascorbate, taken daily Placebo |
Total of all reporting groups | |
Overall Number of Baseline Participants | 18 | 15 | 33 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 18 participants | 15 participants | 33 participants | |
<=18 years |
0 0.0%
|
0 0.0%
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0 0.0%
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Between 18 and 65 years |
11 61.1%
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10 66.7%
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21 63.6%
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>=65 years |
7 38.9%
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5 33.3%
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12 36.4%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 18 participants | 15 participants | 33 participants | |
62.4 (11.4) | 64.6 (9.4) | 63.4 (10.5) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 18 participants | 15 participants | 33 participants | |
Female |
3 16.7%
|
1 6.7%
|
4 12.1%
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Male |
15 83.3%
|
14 93.3%
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29 87.9%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 18 participants | 15 participants | 33 participants |
18 | 15 | 33 | ||
PD Duration
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 18 participants | 15 participants | 33 participants | |
2.9 (1.5) | 3.1 (1.7) | 3.0 (1.6) |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Dr. Rajesh Pahwa |
Organization: | University of Kansas Medical Center |
Phone: | 913-588-6782 |
EMail: | rpahwa@kumc.edu |
Responsible Party: | Rajesh Pahwa, MD, University of Kansas Medical Center |
ClinicalTrials.gov Identifier: | NCT01741701 |
Other Study ID Numbers: |
13397 |
First Submitted: | December 1, 2012 |
First Posted: | December 5, 2012 |
Results First Submitted: | January 18, 2016 |
Results First Posted: | March 17, 2016 |
Last Update Posted: | March 17, 2016 |