NBMI Treatment in Patients With Mercury Toxicity

This is a Controlled Single-Center Double-Blind Crossover Clinical Trial Phase II b conducted in subjects with a history of chronic exposure to mercury in Colombia. One hundred and sixteen patients (116) will be randomized in a 1:1 ratio, to either one of the two arms of this trial: Group A: NBMI (study drug) with an oral dose of 600 mg corresponding to 6 capsules of 100 mg of NBMI every 24 hours for 14 days. Group B: Placebo 6 capsules, every 24 hours for 14 days. This study will consist of 2 time periods/4 visits 1. Screening 2. Day 1 (Treatment start day, 7 days after visit 0) 3. Day 14 ± 3 days (Treatment end day) 4. Day 28 ± 3 days (Treatment drug-free follow-up end day) After Screening a computer-generated scrambling code will be used for allocation in blocks of 4 to the two treatments. During enrollment, the proportion of subjects with or without a history of previous treatment by chelating will be monitored. The identity of patients included in the futility analysis will not be provided to the trial team, in order to preserve the blind aspect of the trial. The trial will be interrupted if the difference between the groups of treatment in the primary assessment is significantly (α = 0.05 unilateral) less than 10% in favor of any of the arms. A Data Monitoring Committee will be set up to monitor the safety and risk control general benefit. The committee's statistician and epidemiologist will carry out the evaluation. The identity of the research product associated with each randomization number will be kept hidden for the trial team and for the patients. The final analysis is planned for when 100% of the patients (116 patients) reach Day 28 of the study.