Mitochondrial Capacity Boost in ALS (MICABO-ALS) Trial

Who is this study for? Patients with Amyotrophic Lateral Sclerosis
What treatments are being studied? Antioxidants
Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 80
Healthy Volunteers: f
View:

• 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).

Locations
United States
Texas
VA North Texas Health Care System
RECRUITING
Dallas
Contact Information
Primary
Rehana Hussain, M.Sc.
rehana.hussain@utsouthwestern.edu
214-648-7244
Backup
Shirley OLeary, NP
Shirley.OLeary@va.gov
214-857-4459
Time Frame
Start Date: 2023-11-02
Estimated Completion Date: 2025-12
Participants
Target number of participants: 60
Treatments
Other: Antioxidants
Eligible patients will receive over-the-counter anti-oxidants, namely vitamin E, NAc cysteine, L-cystine, Nicotinamide and Taurursodiol at defined doses.
Sponsors
Leads: Dallas VA Medical Center

This content was sourced from clinicaltrials.gov