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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
Hospital Doctor Humberto Molina
Zaruma, Ecuador
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)
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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