MedTrace Logo

A 6 Week Study of MG01CI 1400 mg Compared With Placebo in Adults With ADHD ( Attention Deficit/Hyperactivity )

NCT02059642 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2017-03-28

Study results available
· View outcomes & findings →

Summary

This study is a multisite, randomized, double-blind, placebo-controlled, phase 2/3 study of MG01CI (1400 mg daily) for 6 weeks compared with placebo in a 1:1 ratio of 300 adults with ADHD.

Conditions

  • ADHD
  • Attention-Deficit/Hyperactivity Disorder, Predominantly Inattentive Type

Interventions

DRUG

MG01CI (1400 mg)

MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily

DRUG

placebo

Placebo 1400 mg administered orally once daily

Sponsors & Collaborators

  • Alcobra Ltd.

    lead INDUSTRY

Principal Investigators

  • Richard Weisler, MD · University of North Carolina, Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States
  • 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 NCT02059642 on ClinicalTrials.gov