Pilot Proof of Concept Study of NBMI Treatment of Mercury Intoxication

NCT ID: NCT02486289

Last Updated: 2021-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-04-30

Brief Summary

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

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.

Conditions

Mercury Poisoning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Emeramide

Intervention Type: DRUG

Mercury chelator NBMI ((N1,N3-bis(2-mercaptoethyl) isophthalamide)

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.

Group Type: EXPERIMENTAL

Emeramide

Intervention Type: DRUG

Mercury chelator NBMI ((N1,N3-bis(2-mercaptoethyl) isophthalamide)

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

NBMI Placebo

Interventions

Emeramide

Mercury chelator NBMI ((N1,N3-bis(2-mercaptoethyl) isophthalamide)

Intervention Type: DRUG

Placebo

NBMI Placebo

Intervention Type: DRUG

Other Intervention Names

NBMI; Irminix

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NBMI Science AB

UNKNOWN

Sponsor Role: collaborator

EmeraMed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Augusto Focil Baquerizo, MD

Role: PRINCIPAL_INVESTIGATOR

FOMAT Medical Research

Locations

Hospital Doctor Humberto Molina

Zaruma, , Ecuador

Countries

Ecuador

References

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.

Reference Type: DERIVED

PMID: 29444690 (View on PubMed)

Other Identifiers

CTI002

Identifier Type: -

Identifier Source: org_study_id