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A Pilot Study of Oxaloacetate in Subjects With Treated PD

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oxaloacetate (OAA)
Placebo
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oxaloacetate (OAA)

Placebo

Arm Description

active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily

placebo capsules that contain only 100 mg ascorbate, taken daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
December 1, 2012
Last Updated
February 18, 2016
Sponsor
University of Kansas Medical Center
Collaborators
Terra Biological LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01741701
Brief Title
A Pilot Study of Oxaloacetate in Subjects With Treated PD
Official Title
A Pilot Double-Blind, Parallel Group, Placebo Controlled Study of Oxaloacetate in Subjects With Treated Parkinson's Disease (PD)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center
Collaborators
Terra Biological LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxaloacetate (OAA)
Arm Type
Experimental
Arm Description
active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo capsules that contain only 100 mg ascorbate, taken daily
Intervention Type
Drug
Intervention Name(s)
Oxaloacetate (OAA)
Other Intervention Name(s)
benaGene™
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Unified Parkinson's Disease Rating Scale (UPDRS) ADL + Motor Score
Description
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.
Time Frame
4 months
Title
Parkinson's Disease Questionnaire - 39 (PDQ-39)
Description
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.
Time Frame
4 months
Title
Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
4 months
Title
Geriatric Depression Scale (GDS)
Description
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.
Time Frame
4 months
Title
NonMotor Symptom Questionnaire (NMSQuest)
Description
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.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajesh Pahwa, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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A Pilot Study of Oxaloacetate in Subjects With Treated PD

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