Pilot Proof of Concept Study of NBMI Treatment of Mercury Intoxication

Mercury Poisoning Clinical Trial

— NBMI  

Official title:

A Randomized, Placebo-controlled Study to Explore Safety, Dose and Efficacy of NBMI in a Mercury Intoxicated Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02486289
• Other study ID #: CTI002
• Status: Completed
• Phase: Phase 2
• Start date: August 2015
• Est. completion date: April 2016

Study information

• Verified date: March 2021
• Source: EmeraMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized, placebo controlled, double blind proof of concept study of NBMI in treatment of mercury intoxication.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mercury Poisoning
• Poisoning

Intervention

Drug:
• Emeramide
Mercury chelator NBMI ((N1,N3-bis(2-mercaptoethyl) isophthalamide)
• Placebo
NBMI Placebo

Locations

Country	Name	City	State
Ecuador	Hospital Doctor Humberto Molina	Zaruma

Sponsors (2)

Lead Sponsor	Collaborator
EmeraMed	NBMI Science AB

Country where clinical trial is conducted

Ecuador, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mercury Intoxication Medical Score Sum	Changes from baseline in mercury intoxication medical score sum compared between treatment arms.	45 days
Secondary	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.	45 days
Secondary	Fatigue score	Changes from baseline in fatigues score sum compared between treatment arms.	15 days
Secondary	Neuromotoric functions	Changes from baseline in neuromotoric functions objectively assessed and quantified using computerized systems such as CATSYS compared between treatment arms.	45 days
Secondary	Blood mercury levels	Changes from baseline in blood mercury level compared between treatment arms.	45 days
Secondary	Urine mercury levels	Changes from baseline in urine mercury level compared between treatment arms.	45 days
Secondary	NBMI blood levels	NBMI blood levels 0-24 hours after the first and last dose (day 14 dose)	14 days
Secondary	NBMI urine levels	NBMI urine levels 0-24 hours after the first and last dose (day 14 dose)	14 days
Secondary	Adverse events	Adverse event frequency, type and severity compared between treatment arms.	45 days
Secondary	Safety laboratory assessments	Changes from baseline in clinical chemistry and haematology tests compared between treatment arms.	45 days
Secondary	Vital signs	Changes from baseline in vital signs compared between treatment arms.	45 days