Mercury Poisoning
Conditions
Keywords
Mercury toxicity poisoning
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.
Interventions
DRUGEmeramide
Mercury chelator NBMI ((N1,N3-bis(2-mercaptoethyl) isophthalamide)
DRUGPlacebo
NBMI Placebo
Sponsors
NBMI Science AB
EmeraMed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mercury Intoxication Medical Score Sum | 45 days | Changes from baseline in mercury intoxication medical score sum compared between treatment arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue score | 15 days | Changes from baseline in fatigues score sum compared between treatment arms. |
| Neuromotoric functions | 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 | 45 days | Changes from baseline in blood mercury level compared between treatment arms. |
| Urine mercury levels | 45 days | Changes from baseline in urine mercury level compared between treatment arms. |
| Individual components of Mercury Intoxication Medical Score Sum | 45 days | Changes from baseline in individual components of the mercury intoxication medical score sum compared between treatment arms. |
| NBMI urine levels | 14 days | NBMI urine levels 0-24 hours after the first and last dose (day 14 dose) |
| Adverse events | 45 days | Adverse event frequency, type and severity compared between treatment arms. |
| Safety laboratory assessments | 45 days | Changes from baseline in clinical chemistry and haematology tests compared between treatment arms. |
| Vital signs | 45 days | Changes from baseline in vital signs compared between treatment arms. |
| NBMI blood levels | 14 days | NBMI blood levels 0-24 hours after the first and last dose (day 14 dose) |
Countries
Ecuador
Outcome results
None listed