NCT01243242

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Alcobra Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• ADHD

Interventions

Type	Name	Description
DRUG	Metadoxine (MG01CI)	MG01CI 1400 mg, that will be taken daily by the patients for a duration of 6 weeks.

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-08-01
• Completion: 2011-09-01
• First posted: 2010-11-18
• Last updated: 2012-04-20
• Results posted: 2012-04-18

Locations

2 sites across 1 country: Israel