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Antioxidant

Antioxidants for ALS (MICABO-ALS Trial)

Phase 2

Waitlist Available

Led By Olaf Stuve, M.D., Ph.D.

Research Sponsored by Dallas VA Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

MICABO-ALS Trial Summary

This trial is investigating whether giving patients with ALS antioxidants could help slow or stop the progression of the disease. The original trial showed some benefits, so they are expanding it to include higher doses of antioxidants.

Eligible Conditions

Lou Gehrig's Disease

MICABO-ALS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Measurement of serum NfL

Secondary outcome measures

Frequency of serious adverse events and adverse events.

Measurement of functional decline in ALS

Survival analysis

Other outcome measures

Change in serum CK level from baseline to 12 months

MICABO-ALS Trial Design

1Treatment groups

Experimental Treatment

Group I: AntioxidantsExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Antioxidants

2005

Completed Phase 4

~7310

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Dallas VA Medical CenterLead Sponsor

34 Previous Clinical Trials

4,775 Total Patients Enrolled

Olaf Stuve, M.D., Ph.D.Principal InvestigatorDallas VA Medical Center

1 Previous Clinical Trials

9 Total Patients Enrolled

Media Library

Antioxidants (Antioxidant) Clinical Trial Eligibility Overview. Trial Name: NCT04244630 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I be a candidate for this experiment?

"The ideal candidate for this study would be someone with amyotrophic lateral sclerosis that falls in the age range of 21 to 80. A total of 60 patients are needed."

Answered by AI

Has this method been federally sanctioned?

"This is a Phase 2 trial, which means that while there is some data supporting safety, there is none yet to suggest efficacy. Therefore, our team at Power has estimated the safety of this treatment to be a 2."

Answered by AI

Are patients who are 45 years or older able to enroll in this research project?

"The target age group for this clinical trial are adults aged 21 to 80 years old."

Answered by AI

How many subjects are included in this trial?

"The trial is currently underway, with the most recent update to the clinicaltrials.gov page occurring on March 25th, 2022. This study seeks 60 participants from a single site."

Answered by AI

Are researchers looking for more test subjects at this time?

"The clinicaltrials.gov website has the most up-to-date information on this matter, and it does show that the study is still recruiting patients. This particular trial was first posted on April 1st, 2022 and was last edited on March 25th, of the same year. They are looking for a total of 60 individuals who meet the requirements and are willing to participate in this experiment from one location."

Answered by AI

Recent research and studies

Journal of NeurochemistryJournal

Mitochondrial Permeability Transition Mediates Apoptosis Induced by N-methyl(r)salsolinol, an Endogenous Neurotoxin, and Is Inhibited by Bcl-2 and Rasagiline, N-propargyl-1(r)-aminoindan

Akao, Yukihiro, Wakako Maruyama, Shigeomi Shimizu, Hong Yi, Yoshihito Nakagawa, Masayo Shamoto-Nagai, Moussa B. H. Youdim, Yoshihide Tsujimoto, and Makoto Naoi. 2002. “Mitochondrial Permeability Transition Mediates Apoptosis Induced by N-methyl(r)salsolinol, an Endogenous Neurotoxin, and Is Inhibited by Bcl-2 and Rasagiline, N-propargyl-1(r)-aminoindan”. Journal of Neurochemistry. Wiley. doi:10.1046/j.1471-4159.2002.01047.x.

Journal of Neurology, Neurosurgery & PsychiatryJournal

Population Based Epidemiology of Amyotrophic Lateral Sclerosis Using Capture-recapture Methodology

Huisman, M. H. B., S. W. de Jong, P. T. C. van Doormaal, S. S. Weinreich, H. J. Schelhaas, A. J. van der Kooi, M. de Visser, J. H. Veldink, and L. H. van den Berg. 2011. “Population Based Epidemiology of Amyotrophic Lateral Sclerosis Using Capture-recapture Methodology”. Journal of Neurology, Neurosurgery & Psychiatry. BMJ. doi:10.1136/jnnp.2011.244939.

Journal of the Neurological SciencesJournal

El Escorial World Federation of Neurology Criteria for the Diagnosis of Amyotrophic Lateral Sclerosis

Brooks, Benjamin Rix. 1994. “El Escorial World Federation of Neurology Criteria for the Diagnosis of Amyotrophic Lateral Sclerosis”. Journal of the Neurological Sciences. Elsevier BV. doi:10.1016/0022-510x(94)90191-0.

Brain PathologyJournal