Trial of Oxaloacetate in ALS

• Status: Recruiting
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Omar Jawdat
• Collaborators: Clinical Research in ALS and Related Disorders for Therapeutic Development; Rare Diseases Clinical Research Network; Terra Biological LLC

Criteria

Inclusion Criteria:

• A clinical diagnosis by a study investigator of laboratory-supported probable, probable, or definite ALS, according to the modified El Escorial criteria[1]

• Vital capacity (VC) greater or equal to 50% of predicted

• Diagnosis with ALS within 3 years prior to enrollment

• If patients are taking riluzole for ALS, they must be on a stable dose for at least thirty days prior to the baseline visit

• Women of childbearing age must use protection against pregnancy.

Exclusion Criteria:

• Requirement for tracheotomy ventilation or non-invasive ventilation for > 23 hours per day

• Diagnosis of other neurodegenerative diseases (e.g., Parkinson disease, Alzheimer disease)

• Clinically significant history of unstable medical illness (e.g., unstable angina, advanced cancer) over the last 30 days

• Current pregnancy or lactation

• Limited mental capacity such that the patient cannot provide written informed consent or comply with evaluation procedures

• Receipt of any investigational drug within the past 30 days from enrollment