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

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition	Parkinson's Disease
Interventions	Drug: Oxaloacetate (OAA) Drug: Placebo
Enrollment	33

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Oxaloacetate (OAA)	Placebo
Arm/Group Description	active capsule containing 100 mg OA...	placebo capsules that contain only ...
Arm/Group Description	active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily Oxaloacetate (OAA)	placebo capsules that contain only 100 mg ascorbate, taken daily Placebo
Period Title: Overall Study
Started	18	15
Completed	13	13
Not Completed	5	2
Reason Not Completed
Adverse Event	5	1
Withdrawal by Subject	0	1

Baseline Characteristics

Arm/Group Title		Oxaloacetate (OAA)	Placebo	Total
Arm/Group Description		active capsule containing 100 mg OA...	placebo capsules that contain only ...	Total of all reporting groups
Arm/Group Description		active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily Oxaloacetate (OAA)	placebo capsules that contain only 100 mg ascorbate, taken daily Placebo	Total of all reporting groups
Overall Number of Baseline Participants		18	15	33
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	18 participants	15 participants	33 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	11 61.1%	10 66.7%	21 63.6%
	>=65 years	7 38.9%	5 33.3%	12 36.4%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	18 participants	15 participants	33 participants
		62.4 (11.4)	64.6 (9.4)	63.4 (10.5)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	18 participants	15 participants	33 participants
	Female	3 16.7%	1 6.7%	4 12.1%
	Male	15 83.3%	14 93.3%	29 87.9%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	18 participants	15 participants	33 participants
United States		18	15	33
PD Duration Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	18 participants	15 participants	33 participants
		2.9 (1.5)	3.1 (1.7)	3.0 (1.6)

Outcome Measures

1.Primary Outcome


Title	Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
Description	The UPDRS has 3 subscales including Mentation (4 questions based on pa...
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.


Arm/Group Title	Oxaloacetate (OAA)	Placebo
Arm/Group Description:	active capsule containing 100 mg OA...	placebo capsules that contain only ...
Arm/Group Description:	active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily Oxaloacetate (OAA)	placebo capsules that contain only 100 mg ascorbate, taken daily Placebo
Overall Number of Participants Analyzed	13	13
Mean (Standard Deviation) Unit of Measure: units on a scale
UPDRS Total Score at Baseline	41.1 (6.7)	42.9 (10.8)
UPDRS Total Score at 4 months	34.9 (10.4)	34.4 (12.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Oxaloacetate (OAA), Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.50
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

2.Secondary Outcome


Title	Unified Parkinson's Disease Rating Scale (UPDRS) ADL + Motor Score
Description	The UPDRS has 3 subscales including Mentation (4 questions based on pa...
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.


Arm/Group Title	Oxaloacetate (OAA)	Placebo
Arm/Group Description:	active capsule containing 100 mg OA...	placebo capsules that contain only ...
Arm/Group Description:	active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily Oxaloacetate (OAA)	placebo capsules that contain only 100 mg ascorbate, taken daily Placebo
Overall Number of Participants Analyzed	13	13
Mean (Standard Deviation) Unit of Measure: units on a scale
UPDRS ADL + Motor at Baseline	39.4 (6.9)	42.2 (10.7)
UPDRS ADL + Motor at 4 months	33.4 (10.2)	33.9 (11.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Oxaloacetate (OAA), Placebo
	Comments	Comparison of change between groups from baseline to 4 months
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.51
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

3.Secondary Outcome


Title	Parkinson's Disease Questionnaire - 39 (PDQ-39)
Description	The PDQ-39 is a measure of quality of life in Parkinson's disease pati...
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.


Arm/Group Title	Oxaloacetate (OAA)	Placebo
Arm/Group Description:	active capsule containing 100 mg OA...	placebo capsules that contain only ...
Arm/Group Description:	active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily Oxaloacetate (OAA)	placebo capsules that contain only 100 mg ascorbate, taken daily Placebo
Overall Number of Participants Analyzed	13	13
Mean (Standard Deviation) Unit of Measure: percentage of total possible score
PDQ-39 Total Score at Baseline	13.0 (8.9)	10.1 (7.8)
PDQ-39 total score at 4 months	14.4 (11.2)	11.3 (7.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Oxaloacetate (OAA), Placebo
	Comments	Comparison between groups in the change from baseline to 4 months
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.97
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

4.Secondary Outcome


Title	Montreal Cognitive Assessment (MoCA)
Description	The MoCA is an assessment of cognitive function. The total possible sc...
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.


Arm/Group Title	Oxaloacetate (OAA)	Placebo
Arm/Group Description:	active capsule containing 100 mg OA...	placebo capsules that contain only ...
Arm/Group Description:	active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily Oxaloacetate (OAA)	placebo capsules that contain only 100 mg ascorbate, taken daily Placebo
Overall Number of Participants Analyzed	13	13
Mean (Standard Deviation) Unit of Measure: units on a scale
MoCA at Baseline	27.4 (2.0)	27.2 (2.4)
MoCA at 4 months	28.1 (1.6)	27.6 (2.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Oxaloacetate (OAA), Placebo
	Comments	Comparison between groups in the change from baseline to 4 months
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	.77
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

5.Secondary Outcome


Title	Geriatric Depression Scale (GDS)
Description	The GDS is a measure of depression. The scale has 30 yes/no questions....
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.


Arm/Group Title	Oxaloacetate (OAA)	Placebo
Arm/Group Description:	active capsule containing 100 mg OA...	placebo capsules that contain only ...
Arm/Group Description:	active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily Oxaloacetate (OAA)	placebo capsules that contain only 100 mg ascorbate, taken daily Placebo
Overall Number of Participants Analyzed	13	13
Mean (Standard Deviation) Unit of Measure: units on a scale
GDS at Baseline	5.3 (4.4)	3.3 (3.1)
GDS at 4 months	5.8 (5.4)	3.8 (3.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Oxaloacetate (OAA), Placebo
	Comments	Comparison between groups in change from baseline to 4 months
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	.90
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

6.Secondary Outcome


Title	NonMotor Symptom Questionnaire (NMSQuest)
Description	The NMSQuest is a 30 item questionnaire with 30 yes/no questions. Ther...
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.


Arm/Group Title	Oxaloacetate (OAA)	Placebo
Arm/Group Description:	active capsule containing 100 mg OA...	placebo capsules that contain only ...
Arm/Group Description:	active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily Oxaloacetate (OAA)	placebo capsules that contain only 100 mg ascorbate, taken daily Placebo
Overall Number of Participants Analyzed	13	13
Mean (Standard Deviation) Unit of Measure: units on a scale
NMSQuest at Baseline	7.1 (4.4)	6.2 (4.4)
NMSQuest at 4 months	7.9 (6.3)	6.9 (4.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Oxaloacetate (OAA), Placebo
	Comments	Comparison between groups in change from baseline to 4 months
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	.95
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

Adverse Events

Time Frame	Adverse effects for each subject were collected throughout the 4 month study period
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Oxaloacetate (OAA)		Placebo
Arm/Group Description	active capsule containing 100 mg OA...		placebo capsules that contain only ...
Arm/Group Description	active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily Oxaloacetate (OAA)		placebo capsules that contain only 100 mg ascorbate, taken daily Placebo
All-Cause Mortality
	Oxaloacetate (OAA)		Placebo
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events Serious Adverse Events
	Oxaloacetate (OAA)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0.00%)		0/15 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Oxaloacetate (OAA)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/18 (61.11%)		4/15 (26.67%)
Gastrointestinal disorders
GI upset ^†	4/18 (22.22%)	4	0/15 (0.00%)	0
Increased urination ^†	0/18 (0.00%)	0	1/15 (6.67%)	1
General disorders
insomnia/stimulant ^† [1]	3/18 (16.67%)	3	1/15 (6.67%)	1
dizziness ^†	1/18 (5.56%)	1	0/15 (0.00%)	0
Nervous system disorders
Worsening of Parkinson's disease ^†	7/18 (38.89%)	7	1/15 (6.67%)	1
Fatigue ^†	2/18 (11.11%)	2	0/15 (0.00%)	0
Psychiatric disorders
Cognitive worsening ^†	1/18 (5.56%)	1	1/15 (6.67%)	1
† Indicates events were collected by systematic assessment [1] Subjects had difficulty sleeping and felt jittery - described as a stimulant effect by one

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Dr. Rajesh Pahwa
Organization:	University of Kansas Medical Center
Phone:	913-588-6782
EMail:	rpahwa@kumc.edu

Layout table for additonal information

Responsible Party:	Rajesh Pahwa, MD, University of Kansas Medical Center
ClinicalTrials.gov Identifier:	NCT01741701 History of Changes
Other Study ID Numbers:	13397
First Submitted:	December 1, 2012
First Posted:	December 5, 2012
Results First Submitted:	January 18, 2016
Results First Posted:	March 17, 2016
Last Update Posted:	March 17, 2016

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