A Pilot Study of Oxaloacetate in Subjects With Treated PD
| Status: | Completed |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 30 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2012 |
| End Date: | October 2014 |
A Pilot Double-Blind, Parallel Group, Placebo Controlled Study of Oxaloacetate in Subjects With Treated Parkinson's Disease (PD)
The purpose of this study is to determine if Oxaloacetate (OAA) is a safe and effective
treatment for Parkinson's disease. Each subject will be asked to make 3 study visits and
complete two safety follow-up phone calls over a 4 month period.
treatment for Parkinson's disease. Each subject will be asked to make 3 study visits and
complete two safety follow-up phone calls over a 4 month period.
Inclusion Criteria:
- Able to give informed consent and follow instructions per the protocol
- 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:
- Previously taken Oxaloacetate
- 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
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