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| Name | Class |
|---|---|
| Terra Biological LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxaloacetate (OAA) | Experimental | active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily |
|
| Placebo | Placebo Comparator | placebo capsules that contain only 100 mg ascorbate, taken daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxaloacetate (OAA) | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rajesh Pahwa, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxaloacetate (OAA) | active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily Oxaloacetate (OAA) |
| FG001 | Placebo | placebo capsules that contain only 100 mg ascorbate, taken daily Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxaloacetate (OAA) | active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily Oxaloacetate (OAA) |
| BG001 | Placebo | placebo capsules that contain only 100 mg ascorbate, taken daily Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis. | Posted | Mean | Standard Deviation | units on a scale | 4 months |
|
Adverse effects for each subject were collected throughout the 4 month study period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxaloacetate (OAA) | active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily Oxaloacetate (OAA) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| insomnia/stimulant | General disorders | Systematic Assessment | Subjects had difficulty sleeping and felt jittery - described as a stimulant effect by one |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rajesh Pahwa | University of Kansas Medical Center | 913-588-6782 | rpahwa@kumc.edu |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D062907 | Oxaloacetic Acid |
| ID | Term |
|---|---|
| D010071 | Oxaloacetates |
| D010070 | Oxalates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
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| Drug |
|
| 4 months |
| 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 |
| 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 |
| 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 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| PD Duration | Mean | Standard Deviation | years |
|
| OG001 | Placebo | placebo capsules that contain only 100 mg ascorbate, taken daily Placebo |
|
|
|
| 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. | Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis. | Posted | Mean | Standard Deviation | units on a scale | 4 months |
|
|
|
|
| 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. | Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis. | Posted | Mean | Standard Deviation | percentage of total possible score | 4 months |
|
|
|
|
| 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. | Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis. | Posted | Mean | Standard Deviation | units on a scale | 4 months |
|
|
|
|
| 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. | Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis. | Posted | Mean | Standard Deviation | units on a scale | 4 months |
|
|
|
|
| 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. | Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis. | Posted | Mean | Standard Deviation | units on a scale | 4 months |
|
|
|
|
| 0 |
| 18 |
| 11 |
| 18 |
| EG001 | Placebo | placebo capsules that contain only 100 mg ascorbate, taken daily Placebo | 0 | 15 | 4 | 15 |
|
| Worsening of Parkinson's disease | Nervous system disorders | Systematic Assessment |
|
| GI upset | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | Nervous system disorders | Systematic Assessment |
|
| dizziness | General disorders | Systematic Assessment |
|
| Cognitive worsening | Psychiatric disorders | Systematic Assessment |
|
| Increased urination | Gastrointestinal disorders | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D007651 | Keto Acids |