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Completed

NCT Number: NCT01741701

A Pilot Study of Oxaloacetate in Subjects With Treated 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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxaloacetate (OAA)

Drug

Other names: benaGene™

Placebo

Drug

Primary outcomes

  1. Unified Parkinson's Disease Rating Scale (UPDRS) Total Score

    Time frame: 4 months

    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 outcomes

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

    Time frame: 4 months

    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.

  2. Parkinson's Disease Questionnaire - 39 (PDQ-39)

    Time frame: 4 months

    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.

  3. Montreal Cognitive Assessment (MoCA)

    Time frame: 4 months

    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. Geriatric Depression Scale (GDS)

    Time frame: 4 months

    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.

  5. NonMotor Symptom Questionnaire (NMSQuest)

    Time frame: 4 months

    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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • Terra Biological LLC

Registry information

Official study title

A Pilot Double-Blind, Parallel Group, Placebo Controlled Study of Oxaloacetate in Subjects With Treated Parkinson's Disease (PD)

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 5, 2012
Registry last updated
Mar 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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