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Mercury Poisoning clinical trials

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NCT ID: NCT04183595 Recruiting - Mercury Poisoning Clinical Trials

NBMI Treatment in Patients With Mercury Toxicity

NBMI-Hg-COL
Start date: November 22, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

NBMI (N1, N3-Bis-(2-Mercaptoethyl) Isophthalamide) is a new metal chelator drug proposed as an alternative to the current chelators, and it is widely different; compared to the current chelators, consisting of two cysteamine molecules coupled to a single molecule of dicarboxybenzoate. It is used as a chelating agent and has the designation of an orphan drug, in the EU and USA; in the EU it is used for the treatment of mercury toxicity. It is freely soluble in solutions of dimethylformamide (DMF), dimethyl sulfoxide (DMSO) and sodium hydroxide diluted NaOH, slightly soluble in methanol and acetone, and insoluble in water. Pre-clinical data indicates low to no toxicity, and that it reduces the toxicity associated with acute exposure to Hg2+. No other chelator has been reported to prevent acute mercury toxicity with only one exposure to the chelator. It has the ability to penetrate cell membranes and cross the blood-brain barrier and chelate Hg2+ in a complex that eliminates the availability of Hg2+ and essentially eliminates toxic effects. The antioxidant properties of NBMI could also reduce the toxicity levels of hydroxyl free radicals immediately, upon entering cells suffering from oxidative stress. It is possible that the combined chelation of Hg2+ and the elimination of hydroxyl free radicals contribute significantly to the protective effects observed with the NBMI. Previous clinical studies conducted in subjects of the Phase I and Phase II a studies conducted, did not show significant adverse events in patients intoxicated with mercury, all patients who received the study medication have tolerated it well, with only mild or moderate adverse events reported; None of these were considered related to the pharmacological treatment of the study. In addition, there is no potential identified with safety problems in laboratory tests, or vital signs evaluations. The purpose of this Controlled Single-Center Double-Blind Crossover Clinical Trial Phase II b is to determine the efficacy, safety and tolerability of a 14 day 600mg / day of NBMI (N1, N2-bis-2-mercaptoethyl isophthalamide) Treatment, in the reduction of urinary mercury levels versus placebo, in accidentally exposed subjects to mercury in Colombia.

NCT ID: NCT02486289 Completed - Mercury Poisoning Clinical Trials

Pilot Proof of Concept Study of NBMI Treatment of Mercury Intoxication

NBMI
Start date: August 2015
Phase: Phase 2
Study type: Interventional

A randomized, placebo controlled, double blind proof of concept study of NBMI in treatment of mercury intoxication.

NCT ID: NCT00013858 Completed - Lead Poisoning Clinical Trials

Environmental Contaminants and Infant Development

Start date: January 1997
Phase: N/A
Study type: Observational

This study is designed to examine the effects of prenatal exposure to environmental contaminants on cognitive and behavioral development and physical growth in two groups of Inuit infants-one in Northern Quebec; the other in Greenland.