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CompletedNCT02486289NBMIUpdated Mar 8, 2021

Pilot Proof of Concept Study of NBMI Treatment of Mercury Intoxication

A Phase 2 interventional study of Emeramide and Placebo in Mercury Poisoning, sponsored by EmeraMed. Completed at 1 site in Ecuador. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-03-08.

Sponsored by EmeraMed · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Mercury Poisoning

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Keywords

  • Mercury toxicity poisoning
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • DrugEmeramide

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

    Also known as: NBMI, Irminix

  • DrugPlacebo

    NBMI Placebo

05

What researchers measure

Primary outcomes

  1. Mercury Intoxication Medical Score Sum

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

    Time frame: 45 days

Secondary outcomes

  1. Individual components of Mercury Intoxication Medical Score Sum

    Changes from baseline in individual components of the mercury intoxication medical score sum compared between treatment arms.

    Time frame: 45 days

  2. Fatigue score

    Changes from baseline in fatigues score sum compared between treatment arms.

    Time frame: 15 days

  3. Neuromotoric functions

    Changes from baseline in neuromotoric functions objectively assessed and quantified using computerized systems such as CATSYS compared between treatment arms.

    Time frame: 45 days

  4. Blood mercury levels

    Changes from baseline in blood mercury level compared between treatment arms.

    Time frame: 45 days

  5. Urine mercury levels

    Changes from baseline in urine mercury level compared between treatment arms.

    Time frame: 45 days

  6. NBMI blood levels

    NBMI blood levels 0-24 hours after the first and last dose (day 14 dose)

    Time frame: 14 days

  7. NBMI urine levels

    NBMI urine levels 0-24 hours after the first and last dose (day 14 dose)

    Time frame: 14 days

  8. Adverse events

    Adverse event frequency, type and severity compared between treatment arms.

    Time frame: 45 days

  9. Safety laboratory assessments

    Changes from baseline in clinical chemistry and haematology tests compared between treatment arms.

    Time frame: 45 days

  10. Vital signs

    Changes from baseline in vital signs compared between treatment arms.

    Time frame: 45 days

06

Study locations

1 site
  • Hospital Doctor Humberto Molina
    Zaruma, Ecuador
07

References and documents

Publications

  • 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. PubMed 29444690 ↗
08

Registry details

Key details

Study ID
NCT02486289
Lead sponsor
EmeraMed
Collaborators
NBMI Science AB
Responsible party
Sponsor
First posted
Jul 1, 2015
Start date
Aug 2015
Primary completion
Jan 2016
Completion
Apr 2016
Last update
Mar 8, 2021

Study contacts

Augusto Focil Baquerizo, MD
principal investigator · FOMAT Medical Research

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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