A Pilot Study of Oxaloacetate in Subjects With Treated PD

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: Placebo; Drug: Oxaloacetate (OAA)

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oxaloacetate (OAA); active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily	Drug: Oxaloacetate (OAA); Other Names: benaGene™
Placebo Comparator: Placebo; placebo capsules that contain only 100 mg ascorbate, taken daily	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unified Parkinson's Disease Rating Scale (UPDRS) Total Score	The UPDRS has 3 subscales including Mentation (4 questions based on patient report with answers on a scale of 0-4, with a total of 16 points), Activities of Daily Living (13 questions based on patient report with answers on a scale of 0-4, with a total of 52 points) and Motor (27 questions based on clinician assessment on a scale of 0-4, with a total of 108 points). The total scores represents the sum of each of these sections for a total of 176 points with a higher score representing greater dysfunction.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unified Parkinson's Disease Rating Scale (UPDRS) ADL + Motor Score	The UPDRS has 3 subscales including Mentation (4 questions based on patient report with answers on a scale of 0-4, with a total of 16 points), Activities of Daily Living (13 questions based on patient report with answers on a scale of 0-4, with a total of 52 points) and Motor (27 questions based on clinician assessment on a scale of 0-4, with a total of 108 points). This measure examined the ADL + Motor subscales which have a total of 160 points with a higher score representing greater dysfunction.	4 months
Parkinson's Disease Questionnaire - 39 (PDQ-39)	The PDQ-39 is a measure of quality of life in Parkinson's disease patients. It has 39 questions each with a response from 0-4 for a total of 156 points. The total score is calculated as a percentage so the scores of the 39 items are added and divided by 156 and multiplied by 100. The higher the score the worse quality of life.	4 months
Montreal Cognitive Assessment (MoCA)	The MoCA is an assessment of cognitive function. The total possible score ranges from 0 to 30 points with a lower score representing greater cognitive impairment.	4 months
Geriatric Depression Scale (GDS)	The GDS is a measure of depression. The scale has 30 yes/no questions. Each question has a maximum score of 1 and a total possible score ranging from 0 to 30. The higher the score the greater the depression.	4 months
NonMotor Symptom Questionnaire (NMSQuest)	The NMSQuest is a 30 item questionnaire with 30 yes/no questions. There is a total of 30 points with each "yes" score representing 1 point and therefore the higher the score the greater number of nonmotor symptoms present. The score can range from 0 to 30.	4 months

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: Terra Biological LLC
• Investigators: Principal Investigator: Rajesh Pahwa, MD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: December 1, 2012
• First Submitted That Met QC Criteria: December 4, 2012
• First Posted (Estimate): December 5, 2012

Study Record Updates

• Last Update Posted (Estimate): March 17, 2016
• Last Update Submitted That Met QC Criteria: February 18, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 13397

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No