Actively Recruiting

Phase 2
Age: 21Years - 80Years
All Genders
NCT04244630

Mitochondrial Capacity Boost in ALS (MICABO-ALS) Trial

Led by Dallas VA Medical Center · Updated on 2025-08-24

60

Participants Needed

1

Research Sites

108 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Mitochondrial Capacity Boost in ALS (MICABO-ALS) Trial

Who Can Participate

Age: 21Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • A clinical diagnosis of laboratory-supported probable, probable, or definite ALS by a study investigator according to a modified El Escorial criterion
  • Age between 21 and 80 years inclusive
  • If taking riluzole for ALS, must be on a stable dose for at least 30 days before baseline
  • Willing and able to provide signed informed consent approved by the Institutional Review Board (IRB)
Not Eligible

You will not qualify if you...

  • Diagnosis of other neurodegenerative diseases such as Parkinson disease or Alzheimer disease
  • History of unstable medical illness (e.g., unstable angina, advanced cancer) in the last 30 days
  • Infection with human immunodeficiency virus (HIV)
  • Limited mental capacity preventing informed consent or compliance with study procedures
  • History of recent alcohol or drug abuse or noncompliance with treatment or other experimental protocols
  • Receipt of any investigational drug within the past 30 days

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

VA North Texas Health Care System

Dallas, Texas, United States, 75216

Actively Recruiting

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Research Team

R

Rehana Hussain, M.Sc.

CONTACT

S

Shirley OLeary, NP

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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