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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

Study Summary

This trial is studying if a drug called oxaloacetate can help people with Myasthenia Gravis. People in the trial will take the drug or a placebo for 4 weeks at a time.

Eligible Conditions

Myasthenia Gravis

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety (Frequency and Severity of Adverse Events)

Secondary outcome measures

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

465 Previous Clinical Trials

169,287 Total Patients Enrolled

2 Trials studying Myasthenia Gravis

66 Patients Enrolled for Myasthenia Gravis

Terra Biological LLCIndustry Sponsor

6 Previous Clinical Trials

295 Total Patients Enrolled

Mazen Dimachkie, MDPrincipal InvestigatorUniversity of Kansas Medical Center

3 Previous Clinical Trials

455 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How detrimental is Oxaloacetate for human health?

"Our internal assessment of Oxaloacetate's safety is rated as a 1 due to its Phase 1 status, connoting that there are only limited supportive data for both efficacy and hazard."

Answered by AI

Are there any open enrollments for this research endeavor?

"According to clinicaltrials.gov, the trial that started on October 1st 2021 is currently inactive and not recruiting participants. However, there are 84 other studies actively accepting enrollments at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Oxaloacetate in Myasthenia Gravis

2021. "Oxaloacetate in Myasthenia Gravis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04965987.

All > Myasthenia Gravis