Phase 3
Completed N=33
A Pilot Study of Oxaloacetate in Subjects With Treated PD
Source: ClinicalTrials.gov NCT01741701 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Unified Parkinson's Disease Rating Scale (UPDRS) Total Score — 41.1; 42.9; 34.9; 34.4 units on a scale — p=0.50
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Unified Parkinson's Disease Rating Scale (UPDRS) Total Score |
41.1; 42.9; 34.9; 34.4 | 0.50 |
| SECONDARY Unified Parkinson's Disease Rating Scale (UPDRS) ADL + Motor Score |
39.4; 42.2; 33.4; 33.9 | 0.51 |
| SECONDARY Parkinson's Disease Questionnaire - 39 (PDQ-39) |
13.0; 10.1; 14.4; 11.3 | 0.97 |
| SECONDARY Montreal Cognitive Assessment (MoCA) |
27.4; 27.2; 28.1; 27.6 | .77 |
| SECONDARY Geriatric Depression Scale (GDS) |
5.3; 3.3; 5.8; 3.8 | .90 |
| SECONDARY NonMotor Symptom Questionnaire (NMSQuest) |
7.1; 6.2; 7.9; 6.9 | .95 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01741701). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.