Mercury PoisoningPhase 2NBMINCT02486289
Pilot Proof of Concept Study of NBMI Treatment of Mercury Intoxication
A Phase 2 study testing Emeramide in people with Mercury Poisoning, run by EmeraMed at 1 site in Ecuador.
Trial summary
A randomized, placebo controlled, double blind proof of concept study of NBMI in treatment of mercury intoxication. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mercury Poisoning
- What is being tested?
- Emeramide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteEcuador
- Study dates
- Aug 2015to Apr 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, age between 18 and 65 years, inclusive.
- Urine-Hg ≥ 15 μg/L.
- 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.
- Has signed informed consent for participation.
- Willingness and ability to comply with study procedures, visit schedules, and other instructions regarding the study.
Who cannot join
- 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.
- Known or a medical history of renal disorder, significant renal failure, or high risk of renal failure.
- Any clinically significant abnormalities in clinical chemistry or haematology results at the time of screening as judged by the investigator.
- Known or suspected neurodegenerative disorder including but not limited to stroke, polio, Parkinson's and Alzheimer's disease.
- Known or suspected drug or alcohol abuse.
- Positive pregnancy test in women.
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- Serious bacterial and chronic viral infection such as human immunodeficiency virus (HIV) or hepatitis virus.
- 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.
- History of allergy/hypersensitivity to bisulphites (e.g. red/white wine).
- Participation in any other clinical study that included drug treatment within three months of the first administration of investigational product.
- Use of other therapies for mercury intoxication including metal chelators within three months.
- Investigator considers subject unlikely to comply with study procedures, restrictions and requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-controlled Study to Explore Safety, Dose and Efficacy of NBMI in a Mercury Intoxicated Population
A randomized, placebo controlled, double blind proof of concept study of NBMI in treatment of mercury intoxication.
Read the 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.
- Conditions
- Mercury Poisoning
- Being tested
- Emeramide, Placebo
- Keywords
- Mercury toxicity poisoning
- Medical subject headings
- Mercury Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmeramideDrug
Also called NBMI, Irminix
Mercury chelator NBMI ((N1,N3-bis(2-mercaptoethyl) isophthalamide)
PlaceboDrug
NBMI Placebo
| Study group | Role | What they receive |
|---|---|---|
| NBMI (Emeramide) 100mg | 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. Receives: Drug: Emeramide |
| NBMI (Emeramide) 300mg | 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. Receives: Drug: Emeramide |
| Placebo | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mercury Intoxication Medical Score Sum
Changes from baseline in mercury intoxication medical score sum compared between treatment arms.
Measured: 45 days
Secondary outcomes (10)
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.
Measured: 45 days
Fatigue score
Changes from baseline in fatigues score sum compared between treatment arms.
Measured: 15 days
Neuromotoric functions
Changes from baseline in neuromotoric functions objectively assessed and quantified using computerized systems such as CATSYS compared between treatment arms.
Measured: 45 days
Blood mercury levels
Changes from baseline in blood mercury level compared between treatment arms.
Measured: 45 days
Urine mercury levels
Changes from baseline in urine mercury level compared between treatment arms.
Measured: 45 days
NBMI blood levels
NBMI blood levels 0-24 hours after the first and last dose (day 14 dose)
Measured: 14 days
NBMI urine levels
NBMI urine levels 0-24 hours after the first and last dose (day 14 dose)
Measured: 14 days
Adverse events
Adverse event frequency, type and severity compared between treatment arms.
Measured: 45 days
Safety laboratory assessments
Changes from baseline in clinical chemistry and haematology tests compared between treatment arms.
Measured: 45 days
Vital signs
Changes from baseline in vital signs compared between treatment arms.
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionJan 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mercury PoisoningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- EmeraMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NBMI Science AB
- Responsible party
- Sponsor
- Investigators
- Augusto Focil Baquerizo, MD, Principal investigator, FOMAT Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486289
- Sponsor's protocol ID
- CTI002
- Acronym
- NBMI
- Status last verified
- Mar 2021
- First submitted
- 24 Jun 2015
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29444690
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled Study to Explore Safety, Dose and Efficacy of NBMI in a Mercury Intoxicated Population
- ClinicalTrials.gov ID
- NCT02486289
- Acronym / sponsor ID
- NBMI / CTI002
- Conditions
- Mercury Poisoning
- Keywords
- Mercury toxicity poisoning
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- EmeraMedIndustry (pharma, biotech, devices)
- Collaborators
- NBMI Science AB
- Study start
- Aug 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 1 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NBMI (Emeramide) 100mg | Experimental | Drug: EmeramideNBMI 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. |
| NBMI (Emeramide) 300mg | Experimental | Drug: EmeramideNBMI 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. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects, age between 18 and 65 years, inclusive.
- Urine-Hg ≥ 15 μg/L.
- 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.
- Has signed informed consent for participation.
- Willingness and ability to comply with study procedures, visit schedules, and other instructions regarding the study.
Key exclusion criteria (12 listed)
- 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.
- Known or a medical history of renal disorder, significant renal failure, or high risk of renal failure.
- Any clinically significant abnormalities in clinical chemistry or haematology results at the time of screening as judged by the investigator.
- Known or suspected neurodegenerative disorder including but not limited to stroke, polio, Parkinson's and Alzheimer's disease.
- Known or suspected drug or alcohol abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmeramideAlso: NBMI, IrminixMercury chelator NBMI ((N1,N3-bis(2-mercaptoethyl) isophthalamide) | Drug | NBMI (Emeramide) 100mg, NBMI (Emeramide) 300mg |
| PlaceboNBMI Placebo | Drug | Placebo |
Primary outcome
Mercury Intoxication Medical Score Sum
Time frame: 45 days
Changes from baseline in mercury intoxication medical score sum compared between treatment arms.
10 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Derived from this study: PubMed 29444690Schutzmeier 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Augusto Focil Baquerizo, MD principal investigator
FOMAT Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Emeramide in people with Mercury Poisoning, run by EmeraMed at 1 site in Ecuador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mercury Intoxication Medical Score Sum (time frame: 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02486289, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.