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Trial of Oxaloacetate in ALS

NCT04204889 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-06-06

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and the maximal tolerated dose of Oxaloacetate (OAA) in patients with Amyotrophic Lateral Sclerosis (ALS).

Conditions

Interventions

DRUG

Oxaloacetic Acid

The first 3 patients will receive 500 mg twice daily, and subsequent cohorts will increase by 500 mg per dose to a maximum of 2500 mg twice daily.

Sponsors & Collaborators

  • Terra Biological LLC

    collaborator INDUSTRY

  • Omar Jawdat

    lead OTHER

Principal Investigators

  • Omar Jawdat, MD · University of Kansas Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-17
Primary Completion
2023-08-02
Completion
2023-08-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04204889 on ClinicalTrials.gov