A Pilot Study of Oxaloacetate in Subjects With Treated PD

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741701
• Other study ID #: 13397
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 1, 2012
• Last updated: February 18, 2016
• Start date: December 2012
• Est. completion date: October 2014

Study information

• Verified date: February 2016
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Oxaloacetate (OAA)

• Placebo

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Terra Biological LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	4 months	No
Secondary	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.	4 months	No
Secondary	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.	4 months	No
Secondary	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.	4 months	No
Secondary	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.	4 months	No