Mitochondrial Capacity Boost in ALS (MICABO-ALS) Trial
ConditionAmyotrophic Lateral Sclerosis (ALS)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-80
SponsorDallas VA Medical Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Antioxidants
Combination productOver-the-counter anti-oxidants, namely vitamin E, NAc cysteine, L-cystine, Nicotinamide and Taurursodiol at defined doses
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: AntioxidantsOther 1 intervention
Trial outcomes
Primary outcomes
1
Measurement of serum NfL
The change in log serum NfL level from baseline to 12 months will be assessed using a linear mixed model and the differences in NfL level at 12 months from baseline assessed using a paired t-test.
Time frame
12 monthsSecondary outcomes
1
Measurement of functional decline in ALS
Functional decline in ALS patients will be measured using the ALS Functional Rating Scale - Revised (ALSFRS-R), change will be measured from baseline to 12 months. The ALSFRS-R is a quickly administered (five minutes) ordinal rating scale that assesses patients' capability and independence in 12 functional activities.
Time frame
12 months2
Frequency of serious adverse events and adverse events.
The frequency of serious adverse events and adverse events will be summarized using frequency and percentages.
Time frame
12 months3
Survival analysis
This is a robust measure of effect in this rapidly progressing terminal disease. Survival has been a standard outcome measure in past clinical trials.
Time frame
12 monthsOther outcomes
1
Change in serum CK level from baseline to 12 months
CK levels will be measured in a clinical laboratory by colorimetric measurements. Analysis of serum CK levels will be conducted similar to serum NfL.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov