Mitochondrial Capacity Boost in ALS (MICABO-ALS) Trial

Part of paid clinical trials in Dallas, Texas.

Sponsor
Dallas VA Medical Center
Study ID
NCT04244630
Phase
PHASE2
Status
Recruiting
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Conditions

  • Amyotrophic Lateral Sclerosis (ALS)

Eligibility Criteria

Sex
ALL
Age
21 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 2, 2023
Status verified
Aug 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Antioxidants
    Eligible patients will receive over-the-counter anti-oxidants, namely vitamin E, NAc cysteine, L-cystine, Nicotinamide and Taurursodiol at defined doses.

Primary Outcome Measure

Measurement of serum NfL [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA North Texas Health Care SystemDallasTexas75216
Olaf Stuve, MD., Ph.D

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By research site
VA North Texas Health Care System· Dallas, TX

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