A Phase 2 interventional study of Emeramide and Placebo in Mercury Poisoning, sponsored by EmeraMed. Completed at 1 site in Ecuador. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-03-08.
Sponsored by EmeraMed · Phase 2, Interventional, and Treatment
A randomized, placebo controlled, double blind proof of concept study of NBMI in treatment of mercury intoxication.
The objectives of this study are to evaluate the efficacy and safety of two doses of NBMI compared to placebo in mercury intoxicated patients.
EmeraMed is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Emeramide
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.
Drug: Emeramide
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.
Drug: Placebo
Mercury chelator NBMI ((N1,N3-bis(2-mercaptoethyl) isophthalamide)
Also known as: NBMI, Irminix
NBMI Placebo
Mercury Intoxication Medical Score Sum
Changes from baseline in mercury intoxication medical score sum compared between treatment arms.
Time frame: 45 days
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.
Time frame: 45 days
Fatigue score
Changes from baseline in fatigues score sum compared between treatment arms.
Time frame: 15 days
Neuromotoric functions
Changes from baseline in neuromotoric functions objectively assessed and quantified using computerized systems such as CATSYS compared between treatment arms.
Time frame: 45 days
Blood mercury levels
Changes from baseline in blood mercury level compared between treatment arms.
Time frame: 45 days
Urine mercury levels
Changes from baseline in urine mercury level compared between treatment arms.
Time frame: 45 days
NBMI blood levels
NBMI blood levels 0-24 hours after the first and last dose (day 14 dose)
Time frame: 14 days
NBMI urine levels
NBMI urine levels 0-24 hours after the first and last dose (day 14 dose)
Time frame: 14 days
Adverse events
Adverse event frequency, type and severity compared between treatment arms.
Time frame: 45 days
Safety laboratory assessments
Changes from baseline in clinical chemistry and haematology tests compared between treatment arms.
Time frame: 45 days
Vital signs
Changes from baseline in vital signs compared between treatment arms.
Time frame: 45 days
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Emeramide
Mercury Poisoning
EmeraMed