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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at weeks 2, 4, 6, 8, 10, and 12
Awards & highlights

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.

Eligible Conditions
  • Myasthenia Gravis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at weeks 2, 4, 6, 8, 10, and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and at weeks 2, 4, 6, 8, 10, and 12 for reporting.

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 either 500mg BID, 1000mg BID, or 2000mg BID each day for 4 weeks, depending on which cohort they are assigned to.
Group II: PlaceboPlacebo Group1 Intervention
Subjects will take either 500mg BID, 1000mg BID, or 2000mg BID each day for 4 weeks, depending on which cohort they are assigned to.

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Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
488 Previous Clinical Trials
172,443 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
~3 spots leftby Sep 2025
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