Overview

This trial is active, not recruiting.

Condition mercury poisoning
Treatments emeramide, placebo
Phase phase 2
Sponsor Ermes Medical Company Ltd
Collaborator NBMI Science AB (Subsidiary of Ermes Medical Company Ltd)
Start date August 2015
End date January 2016
Trial size 36 participants
Trial identifier NCT02486289, CTI002

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
emeramide NBMI
Mercury chelator NBMI ((N1,N3-bis(2-mercaptoethyl) isophthalamide)
(Experimental)
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.
emeramide NBMI
Mercury chelator NBMI ((N1,N3-bis(2-mercaptoethyl) isophthalamide)
(Placebo Comparator)
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.
placebo
NBMI Placebo

Primary Outcomes

Measure
Mercury Intoxication Medical Score Sum
time frame: 45 days

Secondary Outcomes

Measure
Individual components of Mercury Intoxication Medical Score Sum
time frame: 45 days
Fatigue score
time frame: 15 days
Neuromotoric functions
time frame: 45 days
Blood mercury levels
time frame: 45 days
Urine mercury levels
time frame: 45 days
NBMI blood levels
time frame: 14 days
NBMI urine levels
time frame: 14 days
Adverse events
time frame: 45 days
Safety laboratory assessments
time frame: 45 days
Vital signs
time frame: 45 days

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title A Randomized, Placebo-controlled Study to Explore Safety, Dose and Efficacy of NBMI in a Mercury Intoxicated Population
Principal investigator Augusto Focil Baquerizo, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Ermes Medical Company Ltd.