NCT01741701

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

March 17, 2016

Completed
Last Updated

March 17, 2016

Status Verified

February 1, 2016

Enrollment Period

1.8 years

First QC Date

December 1, 2012

Results QC Date

January 18, 2016

Last Update Submit

February 18, 2016

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Unified Parkinson's Disease Rating Scale (UPDRS) ADL + Motor Score

    4 months

  • Parkinson's Disease Questionnaire - 39 (PDQ-39)

    4 months

  • Montreal Cognitive Assessment (MoCA)

    4 months

  • Geriatric Depression Scale (GDS)

    4 months

  • NonMotor Symptom Questionnaire (NMSQuest)

    4 months

Study Arms (2)

Oxaloacetate (OAA)

EXPERIMENTAL

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

Drug: Oxaloacetate (OAA)

Placebo

PLACEBO COMPARATOR

placebo capsules that contain only 100 mg ascorbate, taken daily

Drug: Placebo

Interventions

Oxaloacetate (OAA)DRUG
Also known as: benaGeneâ„¢
Oxaloacetate (OAA)
PlaceboDRUG
Placebo

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Oxaloacetic Acid

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

OxaloacetatesOxalatesDicarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsKeto Acids

Results Point of Contact

Title
Dr. Rajesh Pahwa
Organization
University of Kansas Medical Center
rpahwa@kumc.edu
913-588-6782

Study Officials

  • Rajesh Pahwa, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Director PD and Movement Disorder Center

Study Record Dates

First Submitted

December 1, 2012

First Posted

December 5, 2012

Study Start

December 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

March 17, 2016

Results First Posted

March 17, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)