Study Comparing Two Doses of MG01CI and Placebo in Adults With Predominantly Inattentive Attention Deficit Hyperactivity Disorder

ADHD Predominantly Inattentive Type Clinical Trial

Official title: Randomized, Double-blind, Single-center, Dose-finding Study Designed to Compare Two Doses of MG01CI (Metadoxine Extended Release) and Placebo in Adults With Predominantly Inattentive Attention Deficit Hyperactivity Disorder

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

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

Related Conditions & MeSH terms

• ADHD Predominantly Inattentive Type
• Attention Deficit Disorder with Hyperactivity

• NCT number: NCT01685281
• Study type: Interventional
• Source: Alcobra Ltd.
• Status: Completed
• Phase: Phase 2
• Start date: August 2013
• Completion date: December 2013