Efficacy Study of Metadoxine SR Formulation in Attention Deficit Hyperactivity Disorder (ADHD) Subjects

Overview

This clinical study is designed to evaluate the safety and tolerability of a single oral administration of a Metadoxine slow release formulation to subjects diagnosed as having ADHD. Study also assess cognitive effects of such drug administration.

Full Title of Study: “Efficacy Study of Metadoxine SR Formulation in ADHD Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2010

Detailed Description

Primary outcome measure is the safety and tolerability of study drug after a single dosing. Additional outcomes include commission error rate from the TOVA test. The result is measured as standard score in % compared to the values of the normal population. Exploratory outcome measures include: 1. TOVA measures like response time , variability, omissions etc. 2. Subtests from Wechsler: digit memory, digit-number signs etc

Interventions

  • Drug: Extended Release Metadoxine
    • one oral 1400mg dose (2 tablets)

Arms, Groups and Cohorts

  • Experimental: Metadoxine SR
    • Metadoxine is a pyrolate salt of Pyridoxine

Clinical Trial Outcome Measures

Primary Measures

  • Safety and Tolerability
    • Time Frame: 24 hours after drug adminstration
    • Subjects were evaluated for general safety and tolerablity measures, including number of AEs and AEs related (possibly or likely) to study drug

Participating in This Clinical Trial

Inclusion Criteria

  • age 18-45 – diagnosed as ADHD Exclusion Criteria:

  • PDD patients – head injured patients – patients suffering from heart, lung, liver, kidney, intestinal, endocrine an neurological diseases and patients who are sensitive to vitamin B

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Alcobra Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Iris Manor, MD, Principal Investigator, Geha MC, Israel

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