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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 below

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My myasthenia gravis is classified as mild, moderate, or severe.

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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:

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I have a chronic illness that causes weakness or fatigue, but it's not myasthenia gravis.

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I have not had any major illnesses in the last 6 months.

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I am not pregnant, breastfeeding, and I use effective birth control methods.

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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

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 1000mg OAA BID for 8 weeks.

Group II: PlaceboPlacebo Group1 Intervention

Subjects will take 1000mg Placebo BID for 8 weeks.

0 / 7Eligibility criteria met