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

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

Tracking Information
First Submitted Date  ICMJE June 24, 2015
First Posted Date  ICMJE July 1, 2015
Last Update Posted Date March 8, 2021
Study Start Date  ICMJE August 2015
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2015)
Mercury Intoxication Medical Score Sum [ Time Frame: 45 days ]
Changes from baseline in mercury intoxication medical score sum compared between treatment arms.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2015)
  • 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.
  • Fatigue score [ Time Frame: 15 days ]
    Changes from baseline in fatigues score sum compared between treatment arms.
  • 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.
  • Blood mercury levels [ Time Frame: 45 days ]
    Changes from baseline in blood mercury level compared between treatment arms.
  • Urine mercury levels [ Time Frame: 45 days ]
    Changes from baseline in urine mercury level compared between treatment arms.
  • NBMI blood levels [ Time Frame: 14 days ]
    NBMI blood levels 0-24 hours after the first and last dose (day 14 dose)
  • NBMI urine levels [ Time Frame: 14 days ]
    NBMI urine levels 0-24 hours after the first and last dose (day 14 dose)
  • Adverse events [ Time Frame: 45 days ]
    Adverse event frequency, type and severity compared between treatment arms.
  • Safety laboratory assessments [ Time Frame: 45 days ]
    Changes from baseline in clinical chemistry and haematology tests compared between treatment arms.
  • Vital signs [ Time Frame: 45 days ]
    Changes from baseline in vital signs compared between treatment arms.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Proof of Concept Study of NBMI Treatment of Mercury Intoxication
Official Title  ICMJE A Randomized, Placebo-controlled Study to Explore Safety, Dose and Efficacy of NBMI in a Mercury Intoxicated Population
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Mercury Poisoning
Intervention  ICMJE
  • Drug: Emeramide
    Mercury chelator NBMI ((N1,N3-bis(2-mercaptoethyl) isophthalamide)
    Other Names:
    • NBMI
    • Irminix
  • Drug: Placebo
    NBMI Placebo
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 26, 2015)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ecuador
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02486289
Other Study ID Numbers  ICMJE CTI002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party EmeraMed
Study Sponsor  ICMJE EmeraMed
Collaborators  ICMJE NBMI Science AB
Investigators  ICMJE
Principal Investigator: Augusto Focil Baquerizo, MD FOMAT Medical Research
PRS Account EmeraMed
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP