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Safety and Tolerability Study of Metadoxine Extended Release (MDX) (Previously Known as MG01CI) in PI-ADHD Adolescent Subjects

NCT02189772 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2015-03-04

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and tolerability of a single administration of Metadoxine Extended Release (MDX) formulation for the treatment of adolescents diagnosed with ADHD that have predominantly inattentive symptoms. The study will also try to evaluate the efficacy of MDX and its level in the blood.

Conditions

  • ADHD, Predominantly Inattentive Type

Interventions

DRUG

Metadoxine extended release

MG01CI

DRUG

Placebo

Inactive drug

Sponsors & Collaborators

  • Alcobra Ltd.

    lead INDUSTRY

Principal Investigators

  • Iris Manor, MD · ADHD Unit, Geha Medical Center, Petah Tikva, Israel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Israel

Study Locations

More Related Trials

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 NCT02189772 on ClinicalTrials.gov