drugset / Trial / NCT04244630

Mitochondrial Capacity Boost in ALS (MICABO-ALS) Trial

NCT04244630

Phase 2 Recruiting 60 enrolled Dallas VA Medical Center
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this research is to investigate the validity of a previous clinical trial named EH301, which showed beneficial effects of anti-oxidant therapies in patients with amyotrophic lateral sclerosis (ALS). If validated by this study, providing over-the-counter anti-oxidants would be a simple, low risk, low-cost approach to significantly slow or stop the progression of ALS, for which currently no effective treatment exists. It is currently thought that oxidative stress is a major cause of ALS. The study investigators are therefore planning to expand the original scope of the previous trial by including anti-oxidants at high doses that were not previously used. All of these compounds are considered safe.

Timeline

Start
2023-11-02
Primary completion
2025-12
Completion
2025-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject L-cystine Unknown
Subject NAc cysteine Unknown
Subject Nicotinamide Other / unclassified
Subject Taurursodiol Small molecule
Subject Vitamin E Other / unclassified