Parkinson's DiseasePhase 2/3NCT01741701
A Pilot Study of Oxaloacetate in Subjects With Treated PD
A Phase 2/3 study testing Oxaloacetate (OAA) in people with Parkinson's Disease, run by University of Kansas Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Oxaloacetate (OAA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Oct 2014
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: A Pilot Double-Blind, Parallel Group, Placebo Controlled Study of Oxaloacetate in Subjects With Treated Parkinson's Disease (PD)
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.
- Conditions
- Parkinson's Disease
- Being tested
- Oxaloacetate (OAA), Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxaloacetate (OAA)Drug
Also called benaGene™
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Oxaloacetate (OAA) | Experimental | active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily Receives: Drug: Oxaloacetate (OAA) |
| Placebo | Placebo comparator | placebo capsules that contain only 100 mg ascorbate, taken daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Terra Biological LLC
- Responsible party
- Principal investigator, Rajesh Pahwa, MD, University of Kansas Medical Center
- Investigators
- Rajesh Pahwa, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741701
- Sponsor's protocol ID
- 13397
- Status last verified
- Feb 2016
- First submitted
- 1 Dec 2012
- Last updated
- 17 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Double-Blind, Parallel Group, Placebo Controlled Study of Oxaloacetate in Subjects With Treated Parkinson's Disease (PD)
- ClinicalTrials.gov ID
- NCT01741701
- Acronym / sponsor ID
- 13397
- Conditions
- Parkinson's Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Terra Biological LLC
- Study start
- Dec 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 5 Dec 2012 (estimated)
- Results
- Posted 17 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxaloacetate (OAA) | Experimental | Drug: Oxaloacetate (OAA)active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily |
| Placebo | Placebo comparator | Drug: Placeboplacebo capsules that contain only 100 mg ascorbate, taken daily |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxaloacetate (OAA)Also: benaGene™ | Drug | Oxaloacetate (OAA) |
| Placebo | Drug | Placebo |
Primary outcome
Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
Time frame: 4 months
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.
5 secondary outcomes
Unified Parkinson's Disease Rating Scale (UPDRS) ADL + Motor Score
Time frame: 4 months
Parkinson's Disease Questionnaire - 39 (PDQ-39)
Time frame: 4 months
Montreal Cognitive Assessment (MoCA)
Time frame: 4 months
Geriatric Depression Scale (GDS)
Time frame: 4 months
NonMotor Symptom Questionnaire (NMSQuest)
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajesh Pahwa, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Oxaloacetate (OAA) in people with Parkinson's Disease, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2016; AzTrials last refreshed its copy on 7 Nov 2026.