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RecruitingPhase 2NCT04244630

Mitochondrial Capacity Boost in ALS (MICABO-ALS) Trial

Sponsor

Dallas VA Medical Center

Enrollment

60 participants

Start Date

Nov 2, 2023

Study Type

INTERVENTIONAL

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.

Eligibility

Min Age: 21 YearsMax Age: 80 Years

Inclusion Criteria4

  • A clinical diagnosis by a study investigator of laboratory-supported probable, probable, or definite ALS, according to a modified El Escorial criterion (Appendix 2).
  • 21 to 80 years of age inclusive.
  • If patients are taking riluzole for ALS, they must be on a stable dose for at least thirty days prior to the baseline visit.
  • Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB).

Exclusion Criteria5

  • Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc.).
  • Clinically significant history of unstable medical illness (unstable angina, advanced cancer, etc.) over the last 30 days.
  • Infection with the human immunodeficiency virus (HIV)
  • Limited mental capacity such that the patient cannot provide written informed consent or comply with evaluation procedures.
  • 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.

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Interventions

COMBINATION_PRODUCTAntioxidants

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

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NCT04244630