Clinical Trial: Pilot Proof of Concept Study of NBMI Treatment of Mercury Intoxication
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Placebo-controlled Study to Explore Safety, Dose and Efficacy of NBMI in a Mercury Intoxicated Population
Brief Summary: A randomized, placebo controlled, double blind proof of concept study of NBMI in treatment of mercury intoxication.
Detailed Summary: The objectives of this study are to evaluate the efficacy and safety of two doses of NBMI compared to placebo in mercury intoxicated patients.
Sponsor: EmeraMed
Current Primary Outcome: Mercury Intoxication Medical Score Sum [ Time Frame: 45 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Individual components of Mercury Intoxication Medical Score Sum [ Time Frame: 45 days ]Changes from baseline in individual components of the mercury intoxication medical score sum compared between treatment arms.
- Fatigue score [ Time Frame: 15 days ]Changes from baseline in fatigues score sum compared between treatment arms.
- Neuromotoric functions [ Time Frame: 45 days ]Changes from baseline in neuromotoric functions objectively assessed and quantified using computerized systems such as CATSYS compared between treatment arms.
- Blood mercury levels [ Time Frame: 45 days ]Changes from baseline in blood mercury level compared between treatment arms.
- Urine mercury levels [ Time Frame: 45 days ]Changes from baseline in urine mercury level compared between treatment arms.
- NBMI blood levels [ Time Frame: 14 days ]NBMI blood levels 0-24 hours after the first and last dose (day 14 dose)
- NBMI urine levels [ Time Frame: 14 days ]NBMI urine levels 0-24 hours after the first and last dose (day 14 dose)
- Adverse events [ Time Frame: 45 days ]Adverse event frequency, type and severity compared between treatment arms.
- Safety laboratory assessments [ Time Frame: 45 days ]Changes from baseline in clinical chemistry and haematology tests compared between treatment arms.
- Vital signs [ Time Frame: 45 days ]Changes from baseline in vital signs compared between treatment arms.
Original Secondary Outcome: Same as current
Information By: EmeraMed
Dates:
Date Received: June 24, 2015
Date Started: August 2015
Date Completion:
Last Updated: April 6, 2017
Last Verified: April 2017