Clinical Efficacy & Safety, of Metadoxine (MG01CI) Extended Release in Attention-Deficit Hyperactivity Disorder (ADHD)

ADHD Clinical Trial

Official title: Randomized, Double-blind, Placebo-controlled, Multi-center Study Designed to Evaluate the Efficacy, Safety and Tolerability of Metadoxine Extended Release in Adults With Attention Deficit Hyperactive Disorder

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate efficacy, safety and tolerability of metadoxine (MG01CI) extended release formulation for the treatment of adults diagnosed with ADHD

Clinical Trial Description

This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with ADHD.

Eligible subjects will be randomly assigned in a 1:1 ratio to one of two treatment groups, 1400 mg Metadoxine (MG01CI) and Placebo. The study will consist of three periods: a screening period of up to 2 weeks, a 6-week double-blind treatment period, and a 2-week safety follow-up period. The total duration of subject participation will be ~10 weeks.

Overview of Study Visits

Screening Period:

Visit 1 - Screening/Baseline Visit (up to 14 days prior to dosing)

Treatment Period:

Visit 2 - Day 0 (Randomization Visit) Visit 3 - Day 7 ± 2 days Visit 4 - Day 14 ± 2 days Visit 5 - Day 28 ± 2 days Visit 6 - Day 42 ± 2 days

Follow-up period:

Visit 7 - Day 56 ± 3 days ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

• NCT number: NCT01243242
• Study type: Interventional
• Source: Alcobra Ltd.
• Status: Completed
• Phase: Phase 2
• Start date: February 2011
• Completion date: September 2011