Pilot Proof of Concept Study of NBMI Treatment of Mercury Intoxication

Phase 2

Completed

• Conditions: Mercury Poisoning
• Interventions: Drug: Placebo; Drug: Emeramide

• Registration Number: NCT02486289
• Lead Sponsor: EmeraMed

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.

Study Timeline

• Study First Submitted: 2015-06-24
• Study First Submitted QC: 2015-06-26
• Study First Posted: 2015-07-01
• Study Start: 2015-08
• Primary Completion: 2016-01
• Study Completion: 2016-04
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-04
• Last Update Posted: 2021-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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.
NBMI (Emeramide) 300mg	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.
NBMI (Emeramide) 100mg	Emeramide	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.

Primary Outcome Measures

Name	Time	Method
Mercury Intoxication Medical Score Sum	45 days	Changes from baseline in mercury intoxication medical score sum compared between treatment arms.

Secondary Outcome Measures

Name	Time	Method
Blood mercury levels	45 days	Changes from baseline in blood mercury level compared between treatment arms.
Adverse events	45 days	Adverse event frequency, type and severity compared between treatment arms.
Vital signs	45 days	Changes from baseline in vital signs compared between treatment arms.
Fatigue score	15 days	Changes from baseline in fatigues 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)
Neuromotoric functions	45 days	Changes from baseline in neuromotoric functions objectively assessed and quantified using computerized systems such as CATSYS compared between treatment arms.
NBMI blood levels	14 days	NBMI blood levels 0-24 hours after the first and last dose (day 14 dose)
Safety laboratory assessments	45 days	Changes from baseline in clinical chemistry and haematology tests 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.
Urine mercury levels	45 days	Changes from baseline in urine mercury level compared between treatment arms.

Trial Locations

Locations (1)

Hospital Doctor Humberto Molina; 🇪🇨 Zaruma, Ecuador