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NCT Number: NCT00995085

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

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ADHD Unit, Geha MHC, Israel

Petah Tikva, Israel

About this study

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:

  • TOVA measures like response time , variability, omissions etc.
  • Subtests from Wechsler: digit memory, digit-number signs etc

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extended Release Metadoxine

Drug

one oral 1400mg dose (2 tablets)

Other names: Metadoxine, Metadoxil

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Alcobra Ltd.

Industry

Registry information

Official study title

Efficacy Study of Metadoxine SR Formulation in ADHD Subjects

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 14, 2009
Registry last updated
Mar 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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