RECRUITING

Mitochondrial Capacity Boost in ALS (MICABO-ALS) Trial

Description

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

Amyotrophic Lateral Sclerosis (ALS)
Talk to us

Related Conditions:

Amyotrophic Lateral Sclerosis (ALS)

Study Overview

On this page

Study Details

Study overview

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.

Mitochondrial Capacity Boost in ALS (MICABO-ALS) Trial

Mitochondrial Capacity Boost in ALS (MICABO-ALS) Trial

Condition
Amyotrophic Lateral Sclerosis (ALS)
Intervention / Treatment

-

Contacts and Locations

Dallas

VA North Texas Health Care System, Dallas, Texas, United States, 75216

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. A clinical diagnosis by a study investigator of laboratory-supported probable, probable, or definite ALS, according to a modified El Escorial criterion (Appendix 2).
  • 2. 21 to 80 years of age inclusive.
  • 3. If patients are taking riluzole for ALS, they must be on a stable dose for at least thirty days prior to the baseline visit.
  • 4. Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB).
  • 1. Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc.).
  • 2. Clinically significant history of unstable medical illness (unstable angina, advanced cancer, etc.) over the last 30 days.
  • 3. Infection with the human immunodeficiency virus (HIV)
  • 4. Limited mental capacity such that the patient cannot provide written informed consent or comply with evaluation procedures.
  • 5. History of recent alcohol or drug abuse or noncompliance with treatment or other experimental protocols. 6 Receipt of any investigational drug within the past 30 days.

Ages Eligible for Study

21 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Dallas VA Medical Center,

Olaf Stuve, M.D., Ph.D., PRINCIPAL_INVESTIGATOR, Dallas VA Medical Center

Study Record Dates

2025-12