Treatment for mercury poisoning using a new drug called NBMI

A Double-blinded, Randomized Controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of N1, N3-bis-(2-Mercaptoethyl) Isophthalamide (NBMI) in the Reduction of Mercury Levels, in Subjects Exposed to Mercury in Colombia

This study tests if a new drug called NBMI can help people with mercury poisoning feel better and reduce their symptoms.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 116 (estimated)
• Ages: 14 Years and up
• Sex: All
• Sponsor: EmeraMed (industry)
• Drugs / interventions: prednisone
• Locations: 1 site (Barranquilla, Atlántico)
• Trial ID: NCT04183595 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of NBMI, a novel metal chelator, in patients with mercury toxicity. It is a controlled, single-center, double-blind crossover trial involving 116 participants who will be randomized to receive either NBMI or a placebo for 14 days. The study aims to assess the drug's ability to reduce mercury toxicity and its safety profile. Participants will undergo multiple visits for screening, treatment, and follow-up assessments.

Who should consider this trial

Good fit: Ideal candidates include individuals with a history of mercury exposure and detectable urinary mercury levels greater than 10 µg/L.

Not a fit: Patients who have previously undergone chelation treatment within the last three months may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a safer and more effective option for patients suffering from mercury poisoning.

How similar studies have performed: While this approach is novel, pre-clinical data suggests potential effectiveness, but there are no prior studies specifically validating NBMI in this context.

Eligibility criteria

Inclusion Criteria:

* Patients with a history of exposure to sources of mercury release by a known event of direct contact with metallic mercury.
* All subjects must have signed and dated an informed consent / assent consent form approved by the IRB in accordance with regulatory and institutional guidelines. This form must be obtained before performing any procedure related to the protocol that is not part of the subject's normal regimen.
* Under age minors must also have a psychological evaluation and documentation of Assent added to the Informed Consent Form.
* Patients with detectable urinary mercury levels \>10 ug / L at the time of screening.
* Patients must be willing and able to comply with clinic visits and all study-related procedures.
* Subjects with no previous chelation treatment or who have stopped receiving chelation treatment for more than 3 months will be enrolled.
* Participants must have controlled mercury levels, with no severe clinical manifestations, regardless of what the medical treatment may have been.

Exclusion Criteria:

* A history of known or suspected hypersensitivity or idiosyncratic reactions to the medication or test excipients. Patients with sulfa-drug sensitivity should be excluded from this study.
* Levels of mercury in urine / blood at the time of baseline measurement that are below detection threshold.
* Known history of drug addiction and / or alcoholism.
* Patients with a known medical condition that, in the opinion of the investigator, could increase the risk associated with participation in the study or with the administration of the study medication (s) under blinded conditions or interfere with the interpretation of the security results.
* Patients with major surgery or significant traumatic injury who have not recovered at least 14 days before the first dose of the study medications (s) under blind.
* Subjects with a condition requiring systemic corticosteroid therapy (\> 10 mg daily of prednisone equivalent) or other immunosuppressive medications within 14 days before or during treatment are excluded.
* Women with positive pregnancy test (urine sample) at the time of screening; or women who are breastfeeding, or are of childbearing age who disagree with taking contraceptives during treatment and until Day 28 after the last dose.

Where this trial is running

Barranquilla, Atlántico

• Clínica de la Costa Ltda. — Barranquilla, Atlántico, Colombia (RECRUITING)

Study contacts

• Principal investigator: Andres Cadena-Bonfanti, MD — Clínica De La Costa Ltda.
• Study coordinator: Haley E Boyd, PhD

Conditions: Mercury Poisoning, Exposure to mercury, NBMI