Pilot Proof of Concept Study of NBMI Treatment of Mercury Intoxication (NBMI)

• ClinicalTrials.gov Identifier: NCT02486289
• Recruitment Status: Completed
• First Posted: July 1, 2015
• Last Update Posted: March 8, 2021
• Sponsor: EmeraMed
• Collaborator: NBMI Science AB
• Information provided by (Responsible Party): EmeraMed

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Mercury Poisoning	Drug: Emeramide; Drug: Placebo	Phase 2

Detailed Description:

The objectives of this study are to evaluate the efficacy and safety of two doses of NBMI compared to placebo in mercury intoxicated patients.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Placebo-controlled Study to Explore Safety, Dose and Efficacy of NBMI in a Mercury Intoxicated Population
• Study Start Date: August 2015
• Actual Primary Completion Date: January 2016
• Actual Study Completion Date: April 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: NBMI (Emeramide) 100mg; NBMI oral capsules 100mg administered once daily. Double dummy used for blinding i.e. 2 x 50mg NBMI + 1 x 200mg placebo capsule equals in total 3 capsules administered daily.	Drug: Emeramide; Mercury chelator NBMI ((N1,N3-bis(2-mercaptoethyl) isophthalamide); Other Names: NBMI; Irminix
Experimental: NBMI (Emeramide) 300mg; NBMI oral capsules 300mg administered once daily. Double dummy used for blinding i.e. 2 x 50mg NBMI + 1 x 200mg NBMI capsule equals in total 3 capsules administered daily.	Drug: Emeramide; Mercury chelator NBMI ((N1,N3-bis(2-mercaptoethyl) isophthalamide); Other Names: NBMI; Irminix
Placebo Comparator: Placebo; Placebo oral capsules administered once daily. Double dummy used for blinding i.e. 2 x 50mg size + 1 x 200mg size placebo capsules equal in total 3 capsules administered daily.	Drug: Placebo; NBMI Placebo

Outcome Measures

Primary Outcome Measures :

1. Mercury Intoxication Medical Score Sum [ Time Frame: 45 days ]
   Changes from baseline in mercury intoxication medical score sum compared between treatment arms.

Secondary Outcome Measures :

1. Individual components of Mercury Intoxication Medical Score Sum [ Time Frame: 45 days ]
   Changes from baseline in individual components of the mercury intoxication medical score sum compared between treatment arms.
2. Fatigue score [ Time Frame: 15 days ]
   Changes from baseline in fatigues score sum compared between treatment arms.
3. Neuromotoric functions [ Time Frame: 45 days ]
   Changes from baseline in neuromotoric functions objectively assessed and quantified using computerized systems such as CATSYS compared between treatment arms.
4. Blood mercury levels [ Time Frame: 45 days ]
   Changes from baseline in blood mercury level compared between treatment arms.
5. Urine mercury levels [ Time Frame: 45 days ]
   Changes from baseline in urine mercury level compared between treatment arms.
6. NBMI blood levels [ Time Frame: 14 days ]
   NBMI blood levels 0-24 hours after the first and last dose (day 14 dose)
7. NBMI urine levels [ Time Frame: 14 days ]
   NBMI urine levels 0-24 hours after the first and last dose (day 14 dose)
8. Adverse events [ Time Frame: 45 days ]
   Adverse event frequency, type and severity compared between treatment arms.
9. Safety laboratory assessments [ Time Frame: 45 days ]
   Changes from baseline in clinical chemistry and haematology tests compared between treatment arms.
10. Vital signs [ Time Frame: 45 days ]
    Changes from baseline in vital signs compared between treatment arms.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion criteria

1. Male or female subjects, age between 18 and 65 years, inclusive.
2. Urine-Hg ≥ 15 μg/L.
3. Mercury intoxication medical score sum (Doering et al. 2014) ≥ 5 or medical score sum ≥ 3 in combination with at least two of the following symptoms; social nervousness/withdrawal, irritability, memory loss, metallic taste, mental- and physical fatigue.
4. Has signed informed consent for participation.
5. Willingness and ability to comply with study procedures, visit schedules, and other instructions regarding the study.

Exclusion criteria

1. History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subjects at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
2. Known or a medical history of renal disorder, significant renal failure, or high risk of renal failure.
3. Any clinically significant abnormalities in clinical chemistry or haematology results at the time of screening as judged by the investigator.
4. Known or suspected neurodegenerative disorder including but not limited to stroke, polio, Parkinson's and Alzheimer's disease.
5. Known or suspected drug or alcohol abuse.
6. Positive pregnancy test in women.
7. Serious bacterial and chronic viral infection such as human immunodeficiency virus (HIV) or hepatitis virus.
8. History of severe allergy/hypersensitivity or on-going allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to NBMI.
9. History of allergy/hypersensitivity to bisulphites (e.g. red/white wine).
10. Participation in any other clinical study that included drug treatment within three months of the first administration of investigational product.
11. Use of other therapies for mercury intoxication including metal chelators within three months.
12. Investigator considers subject unlikely to comply with study procedures, restrictions and requirements.

Contacts and Locations

Locations

Ecuador

Hospital Doctor Humberto Molina

Zaruma, Ecuador

Sponsors and Collaborators

EmeraMed

NBMI Science AB

Investigators

• Principal Investigator: Augusto Focil Baquerizo, MD; FOMAT Medical Research

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Schutzmeier P, Focil Baquerizo A, Castillo-Tandazo W, Focil N, Bose-O'Reilly S. Efficacy of N,N'bis-(2-mercaptoethyl) isophthalamide on mercury intoxication: a randomized controlled trial. Environ Health. 2018 Feb 14;17(1):15. doi: 10.1186/s12940-018-0358-1.

• Responsible Party: EmeraMed
• ClinicalTrials.gov Identifier: NCT02486289
• Other Study ID Numbers: CTI002
• First Posted: July 1, 2015
• Last Update Posted: March 8, 2021
• Last Verified: March 2021

Keywords provided by EmeraMed:

Mercury toxicity poisoning

Additional relevant MeSH terms:

Poisoning; Mercury Poisoning; Chemically-Induced Disorders; Heavy Metal Poisoning; N,N'-Bis(2-mercaptoethyl)isophthalamide; Chelating Agents; Sequestering Agents; Molecular Mechanisms of Pharmacological Action