Mitochondrial Capacity Boost in ALS (MICABO-ALS) Trial
Dallas VA Medical Center
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.
Description
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disorder that affects muscle function throughout the body. Weakness and muscle shrinkage begin either in the face, arm, or leg. A clinical ALS hallmark is rapidly progressive weight loss. Also, respiration is usually affected late in the disease, and death typically occurs as a consequence of respiratory failure. The median survival after disease onset is approximately 3-4 years. While there are now two FDA-approved agents for patients with ALS, there are no interventions that have had a meaningful impact on the natural course of this…
Eligibility
- Age range
- 21–80 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- Combination ProductAntioxidants
Over-the-counter anti-oxidants, namely vitamin E, NAc cysteine, L-cystine, Nicotinamide and Taurursodiol at defined doses
Location
- VA North Texas Health Care SystemDallas, Texas