Pilot Proof of Concept Study of NBMI Treatment of Mercury Intoxication

NCT02486289 | Completed Phase 2

• 1 other identifier: CTI002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mercury Poisoning

Keywords

Mercury toxicity poisoning

Outcome Measures

Primary Outcomes (1)

• Mercury Intoxication Medical Score Sum

  Changes from baseline in mercury intoxication medical score sum compared between treatment arms.

  45 days

Secondary Outcomes (10)

• Individual components of Mercury Intoxication Medical Score Sum

  45 days

• Fatigue score

  15 days

• Neuromotoric functions

  45 days

• Blood mercury levels

  45 days

• Urine mercury levels

  45 days

Study Arms (3)

NBMI (Emeramide) 100mg

EXPERIMENTAL

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

NBMI (Emeramide) 300mg

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Emeramide DRUG

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

Also known as: NBMI, Irminix

NBMI (Emeramide) 100mg; NBMI (Emeramide) 300mg

Placebo DRUG

NBMI Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects, age between 18 and 65 years, inclusive.
• Urine-Hg ≥ 15 μg/L.
• 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.
• Has signed informed consent for participation.
• Willingness and ability to comply with study procedures, visit schedules, and other instructions regarding the study.

You may not qualify if:

• 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.
• Known or a medical history of renal disorder, significant renal failure, or high risk of renal failure.
• Any clinically significant abnormalities in clinical chemistry or haematology results at the time of screening as judged by the investigator.
• Known or suspected neurodegenerative disorder including but not limited to stroke, polio, Parkinson's and Alzheimer's disease.
• Known or suspected drug or alcohol abuse.
• Positive pregnancy test in women.
• Serious bacterial and chronic viral infection such as human immunodeficiency virus (HIV) or hepatitis virus.
• 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.
• History of allergy/hypersensitivity to bisulphites (e.g. red/white wine).
• Participation in any other clinical study that included drug treatment within three months of the first administration of investigational product.
• Use of other therapies for mercury intoxication including metal chelators within three months.
• Investigator considers subject unlikely to comply with study procedures, restrictions and requirements.

Sponsors & Collaborators

• EmeraMed: lead
• NBMI Science AB: collaborator

Study Sites (1)

Hospital Doctor Humberto Molina

Zaruma, Ecuador

Location

Related Publications (1)

• 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.

  PMID: 29444690 DERIVED

MeSH Terms

Conditions

Mercury Poisoning

Interventions

N,N'-Bis(2-mercaptoethyl)isophthalamide

Condition Hierarchy (Ancestors)

Heavy Metal Poisoning; Poisoning; Chemically-Induced Disorders

Study Officials

• Augusto Focil Baquerizo, MD

  FOMAT Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: July 1, 2015
• Study Start: August 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: April 1, 2016
• Last Updated: March 8, 2021

Record last verified: 2021-03

Locations

EC (1)