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A Pilot Study of Oxaloacetate in Subjects With Treated PD

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ClinicalTrials.gov Identifier: NCT01741701
Recruitment Status : Completed
First Posted : December 5, 2012
Results First Posted : March 17, 2016
Last Update Posted : March 17, 2016
Sponsor:
Collaborator:
Terra Biological LLC
Information provided by (Responsible Party):
Rajesh Pahwa, MD, University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Oxaloacetate (OAA) Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Double-Blind, Parallel Group, Placebo Controlled Study of Oxaloacetate in Subjects With Treated Parkinson's Disease (PD)
Study Start Date : December 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oxaloacetate (OAA)
active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily
Drug: Oxaloacetate (OAA)
Other Name: benaGene™

Placebo Comparator: Placebo
placebo capsules that contain only 100 mg ascorbate, taken daily
Drug: Placebo



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741701


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Terra Biological LLC
Investigators
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Principal Investigator: Rajesh Pahwa, MD University of Kansas Medical Center

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Responsible Party: Rajesh Pahwa, MD, Professor, Director PD and Movement Disorder Center, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT01741701     History of Changes
Other Study ID Numbers: 13397
First Posted: December 5, 2012    Key Record Dates
Results First Posted: March 17, 2016
Last Update Posted: March 17, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases