NCT01685281

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Alcobra Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 .

Conditions

• ADHD Predominantly Inattentive Type

Interventions

Type	Name	Description
DRUG	Metadoxine (MG01CI)	MG01CI is an orally administered extended release formulation of metadoxine. Doses: 1400 mg and 700 mg and Placebo
DRUG	Placebo	Placebo tablets will be similar in appearance (color and size) to the investigational product

Timeline

• Start date: 2013-08-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-09-14
• Last updated: 2014-01-14

Locations

1 site across 1 country: Israel