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RECRUITINGPhase 2INTERVENTIONAL

Mitochondrial Capacity Boost in ALS (MICABO-ALS) Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form that has been approved by the Institutional Review Board (IRB). Who Should NOT Join This Trial: 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 weakened immune system virus (HIV) 4. Limited mental capacity such that the patient cannot provide written willing to sign a consent form 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion 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). Exclusion Criteria: 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.

Treatments Being Tested

COMBINATION_PRODUCT

Antioxidants

Over-the-counter anti-oxidants, namely vitamin E, NAc cysteine, L-cystine, Nicotinamide and Taurursodiol at defined doses

Locations (1)

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