Trial Outcomes & Findings for A Pilot Study of Oxaloacetate in Subjects With Treated PD (NCT NCT01741701)
NCT ID: NCT01741701
Last Updated: 2016-03-17
Results Overview
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.
COMPLETED
PHASE2/PHASE3
33 participants
4 months
2016-03-17
Participant Flow
Participant milestones
| Measure |
Oxaloacetate (OAA)
active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily
Oxaloacetate (OAA)
|
Placebo
placebo capsules that contain only 100 mg ascorbate, taken daily
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
15
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Oxaloacetate (OAA)
active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily
Oxaloacetate (OAA)
|
Placebo
placebo capsules that contain only 100 mg ascorbate, taken daily
Placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Pilot Study of Oxaloacetate in Subjects With Treated PD
Baseline characteristics by cohort
| Measure |
Oxaloacetate (OAA)
n=18 Participants
active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily
Oxaloacetate (OAA)
|
Placebo
n=15 Participants
placebo capsules that contain only 100 mg ascorbate, taken daily
Placebo
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
62.4 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
64.6 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
63.4 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
15 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
PD Duration
|
2.9 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
3.1 years
STANDARD_DEVIATION 1.7 • n=7 Participants
|
3.0 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.
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.
Outcome measures
| Measure |
Oxaloacetate (OAA)
n=13 Participants
active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily
Oxaloacetate (OAA)
|
Placebo
n=13 Participants
placebo capsules that contain only 100 mg ascorbate, taken daily
Placebo
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
UPDRS Total Score at Baseline
|
41.1 units on a scale
Standard Deviation 6.7
|
42.9 units on a scale
Standard Deviation 10.8
|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
UPDRS Total Score at 4 months
|
34.9 units on a scale
Standard Deviation 10.4
|
34.4 units on a scale
Standard Deviation 12.4
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.
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.
Outcome measures
| Measure |
Oxaloacetate (OAA)
n=13 Participants
active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily
Oxaloacetate (OAA)
|
Placebo
n=13 Participants
placebo capsules that contain only 100 mg ascorbate, taken daily
Placebo
|
|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS) ADL + Motor Score
UPDRS ADL + Motor at Baseline
|
39.4 units on a scale
Standard Deviation 6.9
|
42.2 units on a scale
Standard Deviation 10.7
|
|
Unified Parkinson's Disease Rating Scale (UPDRS) ADL + Motor Score
UPDRS ADL + Motor at 4 months
|
33.4 units on a scale
Standard Deviation 10.2
|
33.9 units on a scale
Standard Deviation 11.7
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.
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.
Outcome measures
| Measure |
Oxaloacetate (OAA)
n=13 Participants
active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily
Oxaloacetate (OAA)
|
Placebo
n=13 Participants
placebo capsules that contain only 100 mg ascorbate, taken daily
Placebo
|
|---|---|---|
|
Parkinson's Disease Questionnaire - 39 (PDQ-39)
PDQ-39 Total Score at Baseline
|
13.0 percentage of total possible score
Standard Deviation 8.9
|
10.1 percentage of total possible score
Standard Deviation 7.8
|
|
Parkinson's Disease Questionnaire - 39 (PDQ-39)
PDQ-39 total score at 4 months
|
14.4 percentage of total possible score
Standard Deviation 11.2
|
11.3 percentage of total possible score
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.
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.
Outcome measures
| Measure |
Oxaloacetate (OAA)
n=13 Participants
active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily
Oxaloacetate (OAA)
|
Placebo
n=13 Participants
placebo capsules that contain only 100 mg ascorbate, taken daily
Placebo
|
|---|---|---|
|
Montreal Cognitive Assessment (MoCA)
MoCA at Baseline
|
27.4 units on a scale
Standard Deviation 2.0
|
27.2 units on a scale
Standard Deviation 2.4
|
|
Montreal Cognitive Assessment (MoCA)
MoCA at 4 months
|
28.1 units on a scale
Standard Deviation 1.6
|
27.6 units on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.
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.
Outcome measures
| Measure |
Oxaloacetate (OAA)
n=13 Participants
active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily
Oxaloacetate (OAA)
|
Placebo
n=13 Participants
placebo capsules that contain only 100 mg ascorbate, taken daily
Placebo
|
|---|---|---|
|
Geriatric Depression Scale (GDS)
GDS at Baseline
|
5.3 units on a scale
Standard Deviation 4.4
|
3.3 units on a scale
Standard Deviation 3.1
|
|
Geriatric Depression Scale (GDS)
GDS at 4 months
|
5.8 units on a scale
Standard Deviation 5.4
|
3.8 units on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.
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.
Outcome measures
| Measure |
Oxaloacetate (OAA)
n=13 Participants
active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily
Oxaloacetate (OAA)
|
Placebo
n=13 Participants
placebo capsules that contain only 100 mg ascorbate, taken daily
Placebo
|
|---|---|---|
|
NonMotor Symptom Questionnaire (NMSQuest)
NMSQuest at 4 months
|
7.9 units on a scale
Standard Deviation 6.3
|
6.9 units on a scale
Standard Deviation 4.6
|
|
NonMotor Symptom Questionnaire (NMSQuest)
NMSQuest at Baseline
|
7.1 units on a scale
Standard Deviation 4.4
|
6.2 units on a scale
Standard Deviation 4.4
|
Adverse Events
Oxaloacetate (OAA)
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oxaloacetate (OAA)
n=18 participants at risk
active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily
Oxaloacetate (OAA)
|
Placebo
n=15 participants at risk
placebo capsules that contain only 100 mg ascorbate, taken daily
Placebo
|
|---|---|---|
|
General disorders
insomnia/stimulant
|
16.7%
3/18 • Number of events 3 • Adverse effects for each subject were collected throughout the 4 month study period
|
6.7%
1/15 • Number of events 1 • Adverse effects for each subject were collected throughout the 4 month study period
|
|
Nervous system disorders
Worsening of Parkinson's disease
|
38.9%
7/18 • Number of events 7 • Adverse effects for each subject were collected throughout the 4 month study period
|
6.7%
1/15 • Number of events 1 • Adverse effects for each subject were collected throughout the 4 month study period
|
|
Gastrointestinal disorders
GI upset
|
22.2%
4/18 • Number of events 4 • Adverse effects for each subject were collected throughout the 4 month study period
|
0.00%
0/15 • Adverse effects for each subject were collected throughout the 4 month study period
|
|
Nervous system disorders
Fatigue
|
11.1%
2/18 • Number of events 2 • Adverse effects for each subject were collected throughout the 4 month study period
|
0.00%
0/15 • Adverse effects for each subject were collected throughout the 4 month study period
|
|
General disorders
dizziness
|
5.6%
1/18 • Number of events 1 • Adverse effects for each subject were collected throughout the 4 month study period
|
0.00%
0/15 • Adverse effects for each subject were collected throughout the 4 month study period
|
|
Psychiatric disorders
Cognitive worsening
|
5.6%
1/18 • Number of events 1 • Adverse effects for each subject were collected throughout the 4 month study period
|
6.7%
1/15 • Number of events 1 • Adverse effects for each subject were collected throughout the 4 month study period
|
|
Gastrointestinal disorders
Increased urination
|
0.00%
0/18 • Adverse effects for each subject were collected throughout the 4 month study period
|
6.7%
1/15 • Number of events 1 • Adverse effects for each subject were collected throughout the 4 month study period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place