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

NCT01685281 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2014-01-14

No results posted yet for this study

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.

Conditions

  • ADHD Predominantly Inattentive Type

Interventions

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

Sponsors & Collaborators

  • Alcobra Ltd.

    lead INDUSTRY

Principal Investigators

  • Iris Manor, Dr. · Geha Medical center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Israel

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01685281 on ClinicalTrials.gov