study objectives are to compare the efficacy, safety and tolerability of two doses of MG01CI (1400 mg and 700 mg) to Placebo for the treatment of symptoms in adults diagnosed with PI-ADHD. subjects will be randomly assigned in a 1:1:1 ratio to one of three treatment sequences as follows: 1. week 1:1400 mg, week 2:700 mg, week 3:placebo 2. week 1:700 mg,week 2: placebo,week 3:1400 mg 3. week 1: placebo, week2:1400 mg, week 3 700 mg The study will consist of three periods: a screening period of up to one week, a 3-week double-blind treatment period, and a one-week safety follow-up period.
The purpose of this dose finding study is to compare two doses of MG01CI (1400 mg and 700 mg) to Placebo, in adult subjects with PI-ADHD. A crossover study design will allow evaluation of safety/tolerability and efficacy using validated computerized tests. subjects will be randomly assigned in a 1:1:1 ratio to one of three treatment sequences as follows: 1. week 1:1400 mg, week 2:700 mg, week 3:placebo 2. week 1:700 mg,week 2: placebo,week 3:1400 mg 3. week 1: placebo, week2:1400 mg, week 3 700 mg Overview of Study Visits Screening Period: Visit 1 - Screening/Baseline Visit (up to 7 days prior to dosing) Treatment Period: Visit 2 - Day 0 (Randomization Visit) Visit 3 - Day 7 ± 3 days Visit 4 - Day 14 ± 3 days Visit 5 - Day 21 ± 3 days Follow-up period: Visit 6 - Day 28 ± 3 days Study duration for each subject will be up to 35 days .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
MG01CI is an orally administered extended release formulation of metadoxine. Doses: 1400 mg and 700 mg and Placebo
Placebo tablets will be similar in appearance (color and size) to the investigational product
Geha Medical Centre
Petah Tikva, Israel
Change in TOVA ADHD score from Screening/Baseline to 4 hours post-dose;
TOVA® is a computerized test that provides information about an individual's sustained attention, speed and consistency of responding, and behavioral self-regulation and executive functioning
Time frame: 4 weeks
Change in CANTAB sub-scores from baseline (Visit 2) to 4 hours post-dose;
The CANTAB is a computerized test assessing the key cognitive deficits present in ADHD. Sub-scores will include spatial working memory (SWM), stop signal task (SST), rapid visual information processing (RVP), and reaction time (RTI).
Time frame: 4 weeks
Change in TOVA sub-scores from Screening/Baseline to 4 hours post-dose
Time frame: 4 weeks
Number of participants who withdrew early from the study due to AE
Time frame: 5 weeks
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