At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 300 enrolled
Drug / intervention
MG01CI (1400 mg) +1 moredrug
Likely dose
MG01CI (1400 mg)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 6-week Randomized, Multicenter, Double-blind, Parallel, Fixed-dose Study of MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg Compared With Placebo in Adults With Attention Deficit/Hyperactivity Disorder (ADHD)
In Brief
A Phase 3 clinical trial evaluating MG01CI (1400 mg) and placebo for ADHD and Attention-Deficit/Hyperactivity Disorder, Predominantly Inattentive Type. Completed, enrolled 300 participants across 20 sites in 2 countries.
Detailed Summary
This study is a multisite, randomized, double-blind, placebo-controlled, phase 2/3 study of MG01CI (1400 mg daily) for 6 weeks compared with placebo in a 1:1 ratio of 300 adults with ADHD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIsrael, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 2014
Enrollment StartMar 2014
Primary CompletionSep 2014
TodayJul 2026
First PostedFeb 11, 2014
Enrollment StartMar 1, 2014
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 12.4 years ago
Interventions
MG01CI (1400 mg)drug
MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily
placebodrug
Placebo 1400 mg administered orally once daily