Clinical trial NCT02486289: Pilot Proof of Concept Study of NBMI Treatment of Mercury Intoxication
Official title: A Randomized, Placebo-controlled Study to Explore Safety, Dose and Efficacy of NBMI in a Mercury Intoxicated Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mercury Poisoning
Keywords: Mercury toxicity poisoning
Lead sponsor: EmeraMed
Sponsor class: INDUSTRY
Collaborators: name: NBMI Science AB
First posted: 2015-07-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Mercury Intoxication Medical Score Sum
timeFrame: 45 days
Secondary outcomes:
measure: Individual components of Mercury Intoxication Medical Score Sum
timeFrame: 45 days
measure: Fatigue score
timeFrame: 15 days
measure: Neuromotoric functions
timeFrame: 45 days
measure: Blood mercury levels
timeFrame: 45 days
measure: Urine mercury levels
timeFrame: 45 days
measure: NBMI blood levels
timeFrame: 14 days
measure: NBMI urine levels
timeFrame: 14 days
measure: Adverse events
timeFrame: 45 days
measure: Safety laboratory assessments
timeFrame: 45 days
measure: Vital signs
timeFrame: 45 days
Other outcomes:
Locations:
city: Zaruma
country: Ecuador
facility: Hospital Doctor Humberto Molina
Study officials:
affiliation: FOMAT Medical Research
name: Augusto Focil Baquerizo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.