Back to resultsPilot Proof of Concept Study of NBMI Treatment of Mercury Intoxication (NBMI)
Primary Purpose
Mercury Poisoning
Status
Completed
Phase
Phase 2
Locations
Ecuador
Study Type
Interventional
Intervention
Emeramide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Mercury Poisoning focused on measuring Mercury toxicity poisoning
Eligibility Criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Sites / Locations
- Hospital Doctor Humberto Molina
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
NBMI (Emeramide) 100mg
NBMI (Emeramide) 300mg
Placebo
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Mercury Intoxication Medical Score Sum
Changes from baseline in mercury intoxication medical score sum compared between treatment arms.
Secondary Outcome Measures
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.
Fatigue score
Changes from baseline in fatigues score sum compared between treatment arms.
Neuromotoric functions
Changes from baseline in neuromotoric functions objectively assessed and quantified using computerized systems such as CATSYS compared between treatment arms.
Blood mercury levels
Changes from baseline in blood mercury level compared between treatment arms.
Urine mercury levels
Changes from baseline in urine mercury level compared between treatment arms.
NBMI blood levels
NBMI blood levels 0-24 hours after the first and last dose (day 14 dose)
NBMI urine levels
NBMI urine levels 0-24 hours after the first and last dose (day 14 dose)
Adverse events
Adverse event frequency, type and severity compared between treatment arms.
Safety laboratory assessments
Changes from baseline in clinical chemistry and haematology tests compared between treatment arms.
Vital signs
Changes from baseline in vital signs compared between treatment arms.
Full Information
NCT ID
NCT02486289
First Posted
June 24, 2015
Last Updated
March 4, 2021
Sponsor
EmeraMed
Collaborators
NBMI Science AB
1. Study Identification
Unique Protocol Identification Number
NCT02486289
Brief Title
Pilot Proof of Concept Study of NBMI Treatment of Mercury Intoxication
Acronym
NBMI
Official Title
A Randomized, Placebo-controlled Study to Explore Safety, Dose and Efficacy of NBMI in a Mercury Intoxicated Population
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EmeraMed
Collaborators
NBMI Science AB
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mercury Poisoning
Keywords
Mercury toxicity poisoning
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NBMI (Emeramide) 100mg
Arm Type
Experimental
Arm Description
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.
Arm Title
NBMI (Emeramide) 300mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Emeramide
Other Intervention Name(s)
NBMI, Irminix
Intervention Description
Mercury chelator NBMI ((N1,N3-bis(2-mercaptoethyl) isophthalamide)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
NBMI Placebo
Primary Outcome Measure Information:
Title
Mercury Intoxication Medical Score Sum
Description
Changes from baseline in mercury intoxication medical score sum compared between treatment arms.
Time Frame
45 days
Secondary Outcome Measure Information:
Title
Individual components of Mercury Intoxication Medical Score Sum
Description
Changes from baseline in individual components of the mercury intoxication medical score sum compared between treatment arms.
Time Frame
45 days
Title
Fatigue score
Description
Changes from baseline in fatigues score sum compared between treatment arms.
Time Frame
15 days
Title
Neuromotoric functions
Description
Changes from baseline in neuromotoric functions objectively assessed and quantified using computerized systems such as CATSYS compared between treatment arms.
Time Frame
45 days
Title
Blood mercury levels
Description
Changes from baseline in blood mercury level compared between treatment arms.
Time Frame
45 days
Title
Urine mercury levels
Description
Changes from baseline in urine mercury level compared between treatment arms.
Time Frame
45 days
Title
NBMI blood levels
Description
NBMI blood levels 0-24 hours after the first and last dose (day 14 dose)
Time Frame
14 days
Title
NBMI urine levels
Description
NBMI urine levels 0-24 hours after the first and last dose (day 14 dose)
Time Frame
14 days
Title
Adverse events
Description
Adverse event frequency, type and severity compared between treatment arms.
Time Frame
45 days
Title
Safety laboratory assessments
Description
Changes from baseline in clinical chemistry and haematology tests compared between treatment arms.
Time Frame
45 days
Title
Vital signs
Description
Changes from baseline in vital signs compared between treatment arms.
Time Frame
45 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
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.
Exclusion criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Augusto Focil Baquerizo, MD
Organizational Affiliation
FOMAT Medical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Doctor Humberto Molina
City
Zaruma
Country
Ecuador
12. IPD Sharing Statement
Citations:
PubMed Identifier
29444690
Citation
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.
Results Reference
derived
Learn more about this trial
Pilot Proof of Concept Study of NBMI Treatment of Mercury Intoxication
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