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Oxaloacetate for Myasthenia Gravis
Phase 1
Waitlist Available
Led By Mazen Dimachkie, MD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have prior or current documentation of MGFA MG grades 2, 3, or 4A generalized MG, according to the MGFA classification system. These grades correspond to mild (2), moderate (3), and severe (4).
Patients 18 and older.
Must not have
A history of chronic degenerative, severe psychiatric, or neurologic disorder other than MG that can produce weakness or fatigue.
Other major chronic or debilitating illnesses within six months prior to study entry.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at weeks 2, 4, 6, 8, 10, and 12
Summary
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.
Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
As this is a phase 1 trial primarily focused on safety, specific side effects of oxaloacetate in patients with MG aren't listed but may include typical drug reactions such as gastrointestinal discomfort, allergic reactions, or other symptoms depending on individual tolerance.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My myasthenia gravis is classified as mild, moderate, or severe.
Select...
I am 18 years old or older.
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I will not change my myasthenia gravis medications during the study.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a chronic illness that causes weakness or fatigue, but it's not myasthenia gravis.
Select...
I have not had any major illnesses in the last 6 months.
Select...
I am not pregnant, breastfeeding, and I use effective birth control methods.
Select...
I have had my thymus gland removed in the last 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at weeks 2, 4, 6, 8, 10, and 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at weeks 2, 4, 6, 8, 10, and 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety (Frequency and Severity of Adverse Events)
Secondary study objectives
Myasthenia Gravis-specific Activities of Daily Living Scale (MG-ADL) Score
Myasthenia Gravis
Trial Design
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.
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Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
504 Previous Clinical Trials
174,123 Total Patients Enrolled
2 Trials studying Myasthenia Gravis
66 Patients Enrolled for Myasthenia Gravis
Terra Biological LLCIndustry Sponsor
6 Previous Clinical Trials
289 Total Patients Enrolled
Mazen Dimachkie, MDPrincipal InvestigatorUniversity of Kansas Medical Center
3 Previous Clinical Trials
455 Total Patients Enrolled
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