Trial Summary
What is the purpose of this trial?
This trial is testing if oxaloacetate can help people with Myasthenia Gravis. Patients will take different doses of oxaloacetate over a period of time. The goal is to see if oxaloacetate can improve muscle function by boosting energy production in cells.
Eligibility Criteria
This trial is for adults with Myasthenia Gravis (MG) grades 2 to 4A, who can commit to the study schedule and follow-up visits. They must have stable medication doses for at least 30-60 days and cannot be pregnant or breastfeeding without effective birth control. Those with severe psychiatric disorders, recent thymectomy, or participation in another study within the last three months are excluded.Inclusion Criteria
Patients must be willing to give written informed consent before participating in this study. A copy of the signed consent must be kept in the patient's medical record.
My myasthenia gravis is classified as mild, moderate, or severe.
I am willing to complete the study and attend all follow-up visits.
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Exclusion Criteria
My condition has been severe but stable for the last 6 months.
I have a chronic illness that causes weakness or fatigue, but it's not myasthenia gravis.
I have not had any major illnesses in the last 6 months.
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Treatment Details
Interventions
- Oxaloacetate (Other)
- Placebo (Other)
Trial OverviewThe trial tests oxaloacetate's effect on MG over a period of eight weeks: four weeks taking the drug and four weeks on placebo. Participants are divided into three groups receiving different doses to assess safety and potential benefits against muscle weakness caused by MG.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: OxaloacetateActive Control1 Intervention
Oxaloacetate (OAA) is a four-carbon molecule involved in many metabolic pathways, including gluconeogenesis, citric acid cycle, glyoxylate cycle, urea cycle, and amino acid metabolism. In the glyoxylate and citric acid cycles, oxaloacetate is formed as the result of the catalysis by malate dehydrogenase.
Subjects will take 1000mg OAA BID for 8 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Subjects will take 1000mg Placebo BID for 8 weeks.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Kansas Medical CenterKansas City, KS
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Who Is Running the Clinical Trial?
University of Kansas Medical CenterLead Sponsor
Terra Biological LLCIndustry Sponsor