OFF-Time - time when the medication is not working to its full potential and symptoms are not well controlled. This can be predictable such as wearing off between doses when symptoms return at the end of one dose before the next dose is taken; or this can be unpredictable where medication suddenly loses its effect or when a particular dose of medication does not take effect.
A Pilot Study of Oxaloacetate in Subjects With Treated PD
Purpose: The purpose of this study is to determine if Oxaloacetate (OAA) is a safe and effective treatment for Parkinson's disease.
Duration: 4 months
Study Design: Randomized, double-blind, placebo controlled
Both genders ≥ 30 years and older
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
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