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A Pilot Study of Oxaloacetate in Subjects With Treated PD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 1, 2012
First Posted Date  ICMJE December 5, 2012
Results First Submitted Date  ICMJE January 18, 2016
Results First Posted Date  ICMJE March 17, 2016
Last Update Posted Date March 17, 2016
Study Start Date  ICMJE December 2012
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 4, 2012)
safety profile of study drug [ Time Frame: 4 months ]
Evaluate subject safety through data collection with various tests and procedures which include vital signs (blood pressure, heart rate, temperature, respiratory rate, height and weight), number of patients with adverse events and type of adverse events, laboratory blood tests (chem 12 metabolic panel, CBC with differential, serum/plasma amino acids).
Change History Complete list of historical versions of study NCT01741701 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2016)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2012)
efficacy of study drug [ Time Frame: 4 months ]
Evaluate the efficacy of study drug based on change in PD from baseline to 4 months. Includes Unified Parkinson's Disease Rating Scale, Hoehn & Yahr staging, Schwab and England, patient and clinician global impressions, PDQ-39 quality of life assessment, Montreal Cognitive Assessment, Geriatric Depression Scale, Nonmotor Symptoms Questionnaire.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study of Oxaloacetate in Subjects With Treated PD
Official Title  ICMJE A Pilot Double-Blind, Parallel Group, Placebo Controlled Study of Oxaloacetate in Subjects With Treated Parkinson's Disease (PD)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE
  • Drug: Oxaloacetate (OAA)
    Other Name: benaGene™
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Oxaloacetate (OAA)
    active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily
    Intervention: Drug: Oxaloacetate (OAA)
  • Placebo Comparator: Placebo
    placebo capsules that contain only 100 mg ascorbate, taken daily
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2015)
33
Original Estimated Enrollment  ICMJE
 (submitted: December 4, 2012)
30
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01741701
Other Study ID Numbers  ICMJE 13397
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rajesh Pahwa, MD, University of Kansas Medical Center
Study Sponsor  ICMJE University of Kansas Medical Center
Collaborators  ICMJE Terra Biological LLC
Investigators  ICMJE
Principal Investigator: Rajesh Pahwa, MD University of Kansas Medical Center
PRS Account University of Kansas Medical Center
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP