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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

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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oxaloacetate (OAA) Placebo
Hide 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
Arm/Group Title Oxaloacetate (OAA) Placebo Total
Hide 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
Hide 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
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)
1.Primary Outcome
Title Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
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
Hide 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   --/--      --/--    
Hide Serious Adverse Events
Oxaloacetate (OAA) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      0/15 (0.00%)    
Hide 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
[Not Specified]
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    
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