A Pilot Study of Oxaloacetate in Subjects With Treated PD

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Kansas Medical Center
• Collaborator: Terra Biological LLC

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