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

This study has been completed.
Sponsor:
Collaborator:
NBMI Science AB - subsidiary of EmeraMed Ltd
Information provided by (Responsible Party):
EmeraMed
ClinicalTrials.gov Identifier:
NCT02486289
First received: June 24, 2015
Last updated: April 6, 2017
Last verified: April 2017
  Purpose
A randomized, placebo controlled, double blind proof of concept study of NBMI in treatment of mercury intoxication.

Condition Intervention Phase
Mercury Poisoning
Drug: Emeramide
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by EmeraMed:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 36
Study Start Date: August 2015
Study Completion Date: April 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02486289

Locations
Ecuador
Hospital Doctor Humberto Molina
Zaruma, Ecuador
Sponsors and Collaborators
EmeraMed
NBMI Science AB - subsidiary of EmeraMed Ltd
Investigators
Principal Investigator: Augusto Focil Baquerizo, MD FOMAT Medical Research
  More Information

Responsible Party: EmeraMed
ClinicalTrials.gov Identifier: NCT02486289     History of Changes
Other Study ID Numbers: CTI002
Study First Received: June 24, 2015
Last Updated: April 6, 2017

Keywords provided by EmeraMed:
Mercury toxicity poisoning

Additional relevant MeSH terms:
Poisoning
Mercury Poisoning
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on April 24, 2017