RECRUITING

Mitochondrial Capacity Boost in ALS (MICABO-ALS) Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Mitochondrial Capacity Boost in ALS (MICABO-ALS) Trial

Quick Facts

Study Start:2023-11-02
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04244630

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. 21 to 80 years of age inclusive.
  3. 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. 4. Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB).
  1. 1. Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc.).
  2. 2. Clinically significant history of unstable medical illness (unstable angina, advanced cancer, etc.) over the last 30 days.
  3. 3. Infection with the human immunodeficiency virus (HIV)
  4. 4. Limited mental capacity such that the patient cannot provide written informed consent or comply with evaluation procedures.
  5. 5. 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.

Contacts and Locations

Study Contact

Rehana Hussain, M.Sc.
CONTACT
214-648-7244
rehana.hussain@utsouthwestern.edu
Shirley OLeary, NP
CONTACT
214-857-4459
Shirley.OLeary@va.gov

Principal Investigator

Olaf Stuve, M.D., Ph.D.
PRINCIPAL_INVESTIGATOR
Dallas VA Medical Center

Study Locations (Sites)

VA North Texas Health Care System
Dallas, Texas, 75216
United States

Collaborators and Investigators

Sponsor: Dallas VA Medical Center

  • Olaf Stuve, M.D., Ph.D., PRINCIPAL_INVESTIGATOR, Dallas VA Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-02
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-11-02
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Amyotrophic Lateral Sclerosis (ALS)