Mercury PoisoningPhase 2/3NBMI-Hg-COLNCT04183595

NBMI Treatment in Patients With Mercury Toxicity

A Phase 2/3 study testing (N1, N3-bis(2- mercaptoethyl)isophthalamide) and Excipients microcrystalline cellulose, silica and magnesium stearate in people with Mercury Poisoning, run by EmeraMed at 1 site in Colombia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 14 years and olderHealthy volunteers can take part
Conditions the study is for: Mercury Poisoning
What is being tested?: (N1, N3-bis(2- mercaptoethyl)isophthalamide) and Excipients microcrystalline cellulose, silica and magnesium stearate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 116 participants
Where: 1 siteColombia
Study dates: 22 Nov 2023to 22 Nov 2024
Phase: Phase 2/3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 14 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Haley E Boyd, PhD contact

+1-859-266-92 00 (01)

boyd.haley@emeramed.com

Colombia1 site, 1 recruiting

Clínica de la Costa Ltda.
Barranquilla, Atlántico
Cadena-Bonfanti, +57 6053369912, acadena@clinicadelacosta.co
Andres Cadena-Bonfanti
Recruiting

Other trials in Colombia

About this study

Official title: 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

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.

Read the detailed description

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

Screening
Day 1 (Treatment start day, 7 days after visit 0)
Day 14 ± 3 days (Treatment end day)
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.

Conditions: Mercury Poisoning
Being tested: (N1, N3-bis(2- mercaptoethyl)isophthalamide), Excipients microcrystalline cellulose, silica and magnesium stearate
Keywords: Exposure to mercury, NBMI
Medical subject headings: Mercury Poisoning

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

(N1, N3-bis(2- mercaptoethyl)isophthalamide)Drug
Also called NBMI
600mg / day NBMI treatment for 14 days, administered as four capsules of 100 mg of NBMI every 24 hours, at the start of treatment, the principal investigator or his delegate will verify the intake of the first dose and deliver a blister pack corresponding to the remaining NBMI capsules, at visit day 14 research subjects will be asked to return the packaging with the remaining capsules or not, in order to estimate adherence to treatment.
Excipients microcrystalline cellulose, silica and magnesium stearateOther
Also called Placebo
6 Capsules will be administered every 24 hours for 14 days.

Study groups in NCT04183595
Study group	Role	What they receive
Arm A: NBMI (Study Medication)	Experimental	600mg / day N1, N3-BIS- (2-MERCAPTOETHYL) ISOPHTHALAMIDE (NBMI) treatment for 14 days, administered as four capsules of 100 mg of NBMI every 24 hours. Receives: Drug: (N1, N3-bis(2- mercaptoethyl)isophthalamide)
Arm B: Placebo	Placebo comparator	(Excipients microcrystalline cellulose, silica and magnesium stearate) capsules will be administered every 24 hours for 14 days. Receives: Other: Excipients microcrystalline cellulose, silica and magnesium stearate

What is being measured

The primary outcome is the main question the study is designed to answer.

Measure the "Change in the subject's urine mercury levels"
Evaluation of the difference in mercury levels in the urine as percentage of mercury concentration levels will be determined. The percentage is calculated by comparing baseline mercury concentration levels, against the levels observed at 14-day and 28-days follow-up visits. A rule of three is applied to determine the percentage (%) of change. The analysis of total Hg concentration will be done via Cold Vapor Atomic Absorption spectrometry
Measured: Baseline (Before) treatment, Fourteen (14) days after the start of treatment, Fourteen (14) days after the end of treatment

Secondary outcomes (9)

Measure the "Change in the subject's blood iron levels"
To measure the efficacy, the evaluation of the difference in blood iron levels as the percentages of iron concentration, will be calculated. Immunoturbidimetry Test will be used as an indicator of iron reserves to determine serum ferritin (FS) levels.
Measured: Baseline (Before) treatment, Fourteen (14) days after the start of treatment, Fourteen (14) days after the end of treatment
Measure the "Change in the subject's blood glucose levels"
To measure efficacy, the evaluation of the difference in blood glucose levels, as percentage of glucose concentration, will be determined.
Measured: Baseline (Before) treatment, Fourteen (14) days after the start of treatment, Fourteen (14) days after the end of treatment
Measure the "Change in the subject's renal function"
The difference in scores derived from the CKD-EPI Equation will be evaluated.
Measured: Baseline (Before) treatment, Fourteen (14) days after the start of treatment, Fourteen (14) days after the end of treatment
Measure the "Frequency and Severity of Adverse Events"
Frequency and Severity of Adverse Events in the 14 day 400mg / day NBMI Treatment Group. Adverse Events will be encoded using the most recent version of the Medical Dictionary for Regulatory Activities.
Measured: From the first dose of study medication until the Day 56 visit.
Measure subject's "Variations in Mental Response ".
The European Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L) to evaluate quality of life is an instrument to assess the state of health in multiple dimensions. The questionnaire has five questions with Likert (descriptive system) and an analog visual scale (EQ-VAS). The descriptive system defines health in terms of 5 dimensions: mobility, self-care, habitual activities, pain/discomfort and anxiety/Depression. Each dimension has 5 response categories: no problem, mild problems, moderate problems, serious problems and extreme problems. The EQ-VAS marked 0 (worst state of health) -100 (best state of health). The combination of the score in each dimension calculates an index value EQus which is equivalent to the QALY (quality-adjusted life year) value. Thus EQus= 1 is equivalent to QALY = 1, that means a year lived with perfect health, an EQus <1 is equivalent to a year lived with a lower level of health and EQus = 0 is equivalent to being dead.
Measured: Baseline (Before) treatment, Fourteen (14) days after the start of treatment, Fourteen (14) days after the end of treatment
Measure subject's "Variations in General Clinical examination".
A general physical examination of systems and organs will be conducted to determine whether there is or there is not a variation of health status (Yes/No scale). The organs and system that will be examined to determine a general health status are Head and Neck, Oral Cavity, Eyes, Ears, Nose, Cardiovascular System, Chest and Lungs, Abdomen, Skin, Lymphatic System, Neurological System, Renal System, Musculoskeletal System, Appearance).
Measured: Baseline (Before) treatment, Fourteen (14) days after the start of treatment, Fourteen (14) days after the end of treatment
Measure subject's "Variations in Height".
As part of general physical examination variations in participants height will be measured in centimeters comparing measurements in the three visits.
Measured: Baseline (Before) treatment, Fourteen (14) days after the start of treatment, Fourteen (14) days after the end of treatment
Measure subject's "Variations in Weight".
As part of general physical examination variations in participants weight will be measured in kilograms comparing measurements in the three visits.
Measured: Baseline (Before) treatment, Fourteen (14) days after the start of treatment, Fourteen (14) days after the end of treatment
Mercury intoxication measured by Medical Intoxication Score
The medical intoxication score (MIS) is a tool created to identify mercury poisoning in patients. It is a score of ten points that is evaluated by a medical examination, neuromotor tests and an anamnestic questionnaire evaluating 8 elements: 1. Excessive salivation 2. Tremor during work 3. Problems sleeping at night 4. Bluish discoloration of the gums 5. Ataxic gait 6. Dysdiadocokinesia 7. Heel and chin test 8. Proteinuria. Each can have an assigned value of 0 or 1, specific to whether the symptom is absent (0) or present (1) or if the test result is negative (0) or positive (1). The medical score of mercury poisoning is the sum of the values of the elements.
The worst case of worsening intoxication symptoms would be 10 and a healthy participant will get 0 score. Intoxication will be considered if score is 6 or greater than 6.
Measured: Baseline (Before) treatment, Fourteen (14) days after the start of treatment, Fourteen (14) days after the end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Nov 202322 Nov 2024

First posted3 Dec 2019
Study start22 Nov 2023
Primary completion22 May 2024 (estimated)
Study completion22 Nov 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Mercury PoisoningStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: One hundred and sixteen (116) participants will be randomized in a 1:1 ratio, to either one of the two arms of this trial. 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)
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 116 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04183595
Sponsor's protocol ID: Emera008
Acronym: NBMI-Hg-COL
Status last verified: Mar 2024
First submitted: 19 Jun 2019
Last updated: 12 Mar 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Cordy P, Veiga MM, Salih I, Al-Saadi S, Console S, Garcia O, Mesa LA, Velasquez-Lopez PC, Roeser M. Mercury contamination from artisanal gold mining in Antioquia, Colombia: The world's highest per capita mercury pollution. Sci Total Environ. 2011 Dec 1;410-411:154-60. doi: 10.1016/j.scitotenv.2011.09.006. Epub 2011 Oct 15.
PubMed 22000915
Erkek N, Senel S, Sarac A, Ertan U, Karacan CD. Being alive after a severe inorganic mercury intoxication. Eur J Pediatr. 2010 May;169(5):625-8. doi: 10.1007/s00431-009-1073-2. Epub 2009 Oct 4.
PubMed 19802724
Khan F, Momtaz S, Abdollahi M. The relationship between mercury exposure and epigenetic alterations regarding human health, risk assessment and diagnostic strategies. J Trace Elem Med Biol. 2019 Mar;52:37-47. doi: 10.1016/j.jtemb.2018.11.006. Epub 2018 Nov 14.
PubMed 30732897
Zeitz P, Orr MF, Kaye WE. Public health consequences of mercury spills: Hazardous Substances Emergency Events Surveillance system, 1993-1998. Environ Health Perspect. 2002 Feb;110(2):129-32. doi: 10.1289/ehp.02110129.
PubMed 11836139
Schober SE, Sinks TH, Jones RL, Bolger PM, McDowell M, Osterloh J, Garrett ES, Canady RA, Dillon CF, Sun Y, Joseph CB, Mahaffey KR. Blood mercury levels in US children and women of childbearing age, 1999-2000. JAMA. 2003 Apr 2;289(13):1667-74. doi: 10.1001/jama.289.13.1667.
PubMed 12672735
Park JD, Zheng W. Human exposure and health effects of inorganic and elemental mercury. J Prev Med Public Health. 2012 Nov;45(6):344-52. doi: 10.3961/jpmph.2012.45.6.344. Epub 2012 Nov 29.
PubMed 23230464
Ha E, Basu N, Bose-O'Reilly S, Dorea JG, McSorley E, Sakamoto M, Chan HM. Current progress on understanding the impact of mercury on human health. Environ Res. 2017 Jan;152:419-433. doi: 10.1016/j.envres.2016.06.042. Epub 2016 Jul 18.
PubMed 27444821
Branco V, Caito S, Farina M, Teixeira da Rocha J, Aschner M, Carvalho C. Biomarkers of mercury toxicity: Past, present, and future trends. J Toxicol Environ Health B Crit Rev. 2017;20(3):119-154. doi: 10.1080/10937404.2017.1289834. Epub 2017 Apr 5.
PubMed 28379072
Clarkson TW, Magos L. The toxicology of mercury and its chemical compounds. Crit Rev Toxicol. 2006 Sep;36(8):609-62. doi: 10.1080/10408440600845619.
PubMed 16973445
Clarke D, Buchanan R, Gupta N, Haley B. Amelioration of Acute Mercury Toxicity by a Novel, Non-Toxic Lipid Soluble Chelator N,N'bis-(2-mercaptoethyl)isophthalamide: Effect on Animal Survival, Health, Mercury Excretion and Organ Accumulation. Toxicol Environ Chem. 2012;94(3):616-640. doi: 10.1080/02772248.2012.657199.
PubMed 22573916
Risher JF, Amler SN. Mercury exposure: evaluation and intervention the inappropriate use of chelating agents in the diagnosis and treatment of putative mercury poisoning. Neurotoxicology. 2005 Aug;26(4):691-9. doi: 10.1016/j.neuro.2005.05.004.
PubMed 16009427
George GN, Prince RC, Gailer J, Buttigieg GA, Denton MB, Harris HH, Pickering IJ. Mercury binding to the chelation therapy agents DMSA and DMPS and the rational design of custom chelators for mercury. Chem Res Toxicol. 2004 Aug;17(8):999-1006. doi: 10.1021/tx049904e.
PubMed 15310232
Bose-O'Reilly S, Bernaudat L, Siebert U, Roider G, Nowak D, Drasch G. Signs and symptoms of mercury-exposed gold miners. Int J Occup Med Environ Health. 2017 Mar 30;30(2):249-269. doi: 10.13075/ijomeh.1896.00715. Epub 2017 Mar 22.
PubMed 28366955
Doering S, Bose-O'Reilly S, Berger U. Essential Indicators Identifying Chronic Inorganic Mercury Intoxication: Pooled Analysis across Multiple Cross-Sectional Studies. PLoS One. 2016 Aug 30;11(8):e0160323. doi: 10.1371/journal.pone.0160323. eCollection 2016.
PubMed 27575533

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04183595
Acronym / sponsor ID: NBMI-Hg-COL / Emera008
Conditions: Mercury Poisoning
Keywords: Exposure to mercury, NBMI
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 116 participants (estimated)
Lead sponsor: EmeraMedIndustry (pharma, biotech, devices)
Study start: 22 Nov 2023 (actual)
Primary completion: 22 May 2024 (estimated)
Study completion: 22 Nov 2024 (estimated)
First posted: 3 Dec 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Screening
Day 1 (Treatment start day, 7 days after visit 0)
Day 14 ± 3 days (Treatment end day)
Day 28 ± 3 days (Treatment drug-free follow-up end day)

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: One hundred and sixteen (116) participants will be randomized in a 1:1 ratio, to either one of the two arms of this trial. 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)

Arm	Type	Receives
Arm A: NBMI (Study Medication)	Experimental	Drug: (N1, N3-bis(2- mercaptoethyl)isophthalamide)600mg / day N1, N3-BIS- (2-MERCAPTOETHYL) ISOPHTHALAMIDE (NBMI) treatment for 14 days, administered as four capsules of 100 mg of NBMI every 24 hours.
Arm B: Placebo	Placebo comparator	Other: Excipients microcrystalline cellulose, silica and magnesium stearate(Excipients microcrystalline cellulose, silica and magnesium stearate) capsules will be administered every 24 hours for 14 days.

Who may qualify

Ages: 14 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
(N1, N3-bis(2- mercaptoethyl)isophthalamide)Also: NBMI600mg / day NBMI treatment for 14 days, administered as four capsules of 100 mg of NBMI every 24 hours, at the start of treatment, the principal investigator or his delegate will verify the intake of the first dose and deliver a blister pack corresponding to the remaining NBMI capsules, at visit day 14 research subjects will be asked to return the packaging with the remaining capsules or not, in order to estimate adherence to treatment.	Drug	Arm A: NBMI (Study Medication)
Excipients microcrystalline cellulose, silica and magnesium stearateAlso: Placebo6 Capsules will be administered every 24 hours for 14 days.	Other	Arm B: Placebo

Primary outcome

Measure the "Change in the subject's urine mercury levels"
Time frame: Baseline (Before) treatment, Fourteen (14) days after the start of treatment, Fourteen (14) days after the end of treatment
Evaluation of the difference in mercury levels in the urine as percentage of mercury concentration levels will be determined. The percentage is calculated by comparing baseline mercury concentration levels, against the levels observed at 14-day and 28-days follow-up visits. A rule of three is applied to determine the percentage (%) of change. The analysis of total Hg concentration will be done via Cold Vapor Atomic Absorption spectrometry

9 secondary outcomes

Measure the "Change in the subject's blood iron levels"
Time frame: Baseline (Before) treatment, Fourteen (14) days after the start of treatment, Fourteen (14) days after the end of treatment
Measure the "Change in the subject's blood glucose levels"
Time frame: Baseline (Before) treatment, Fourteen (14) days after the start of treatment, Fourteen (14) days after the end of treatment
Measure the "Change in the subject's renal function"
Time frame: Baseline (Before) treatment, Fourteen (14) days after the start of treatment, Fourteen (14) days after the end of treatment
Measure the "Frequency and Severity of Adverse Events"
Time frame: From the first dose of study medication until the Day 56 visit.
Measure subject's "Variations in Mental Response ".
Time frame: Baseline (Before) treatment, Fourteen (14) days after the start of treatment, Fourteen (14) days after the end of treatment
Measure subject's "Variations in General Clinical examination".
Time frame: Baseline (Before) treatment, Fourteen (14) days after the start of treatment, Fourteen (14) days after the end of treatment
Measure subject's "Variations in Height".
Time frame: Baseline (Before) treatment, Fourteen (14) days after the start of treatment, Fourteen (14) days after the end of treatment
Measure subject's "Variations in Weight".
Time frame: Baseline (Before) treatment, Fourteen (14) days after the start of treatment, Fourteen (14) days after the end of treatment
Mercury intoxication measured by Medical Intoxication Score
Time frame: Baseline (Before) treatment, Fourteen (14) days after the start of treatment, Fourteen (14) days after the end of treatment

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
Background: PubMed 22000915Cordy P, Veiga MM, Salih I, Al-Saadi S, Console S, Garcia O, Mesa LA, Velasquez-Lopez PC, Roeser M. Mercury contamination from artisanal gold mining in Antioquia, Colombia: The world's highest per capita mercury pollution. Sci Total Environ. 2011 Dec 1;410-411:154-60. doi: 10.1016/j.scitotenv.2011.09.006. Epub 2011 Oct 15.
Background: PubMed 19802724Erkek N, Senel S, Sarac A, Ertan U, Karacan CD. Being alive after a severe inorganic mercury intoxication. Eur J Pediatr. 2010 May;169(5):625-8. doi: 10.1007/s00431-009-1073-2. Epub 2009 Oct 4.
Background: PubMed 30732897Khan F, Momtaz S, Abdollahi M. The relationship between mercury exposure and epigenetic alterations regarding human health, risk assessment and diagnostic strategies. J Trace Elem Med Biol. 2019 Mar;52:37-47. doi: 10.1016/j.jtemb.2018.11.006. Epub 2018 Nov 14.
Background: PubMed 11836139Zeitz P, Orr MF, Kaye WE. Public health consequences of mercury spills: Hazardous Substances Emergency Events Surveillance system, 1993-1998. Environ Health Perspect. 2002 Feb;110(2):129-32. doi: 10.1289/ehp.02110129.
Background: PubMed 12672735Schober SE, Sinks TH, Jones RL, Bolger PM, McDowell M, Osterloh J, Garrett ES, Canady RA, Dillon CF, Sun Y, Joseph CB, Mahaffey KR. Blood mercury levels in US children and women of childbearing age, 1999-2000. JAMA. 2003 Apr 2;289(13):1667-74. doi: 10.1001/jama.289.13.1667.
Background: PubMed 23230464Park JD, Zheng W. Human exposure and health effects of inorganic and elemental mercury. J Prev Med Public Health. 2012 Nov;45(6):344-52. doi: 10.3961/jpmph.2012.45.6.344. Epub 2012 Nov 29.
Background: PubMed 27444821Ha E, Basu N, Bose-O'Reilly S, Dorea JG, McSorley E, Sakamoto M, Chan HM. Current progress on understanding the impact of mercury on human health. Environ Res. 2017 Jan;152:419-433. doi: 10.1016/j.envres.2016.06.042. Epub 2016 Jul 18.
Background: PubMed 28379072Branco V, Caito S, Farina M, Teixeira da Rocha J, Aschner M, Carvalho C. Biomarkers of mercury toxicity: Past, present, and future trends. J Toxicol Environ Health B Crit Rev. 2017;20(3):119-154. doi: 10.1080/10937404.2017.1289834. Epub 2017 Apr 5.
Background: PubMed 16973445Clarkson TW, Magos L. The toxicology of mercury and its chemical compounds. Crit Rev Toxicol. 2006 Sep;36(8):609-62. doi: 10.1080/10408440600845619.
Background: PubMed 22573916Clarke D, Buchanan R, Gupta N, Haley B. Amelioration of Acute Mercury Toxicity by a Novel, Non-Toxic Lipid Soluble Chelator N,N'bis-(2-mercaptoethyl)isophthalamide: Effect on Animal Survival, Health, Mercury Excretion and Organ Accumulation. Toxicol Environ Chem. 2012;94(3):616-640. doi: 10.1080/02772248.2012.657199.
Background: PubMed 16009427Risher JF, Amler SN. Mercury exposure: evaluation and intervention the inappropriate use of chelating agents in the diagnosis and treatment of putative mercury poisoning. Neurotoxicology. 2005 Aug;26(4):691-9. doi: 10.1016/j.neuro.2005.05.004.
Background: PubMed 15310232George GN, Prince RC, Gailer J, Buttigieg GA, Denton MB, Harris HH, Pickering IJ. Mercury binding to the chelation therapy agents DMSA and DMPS and the rational design of custom chelators for mercury. Chem Res Toxicol. 2004 Aug;17(8):999-1006. doi: 10.1021/tx049904e.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Haley E Boyd, PhD contact

+1-859-266-92 00 (01)

boyd.haley@emeramed.com

Andres Cadena-Bonfanti, MD principal investigator

Clínica De La Costa Ltda.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Haley E Boyd, PhD (+1-859-266-92 00 (01), boyd.haley@emeramed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measure the "Change in the subject's urine mercury levels" (time frame: Baseline (Before) treatment, Fourteen (14) days after the start of treatment, Fourteen (14) days after the end of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04183595, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.