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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:
Efficacy Study of Metadoxine SR Formulation in ADHD Subjects

Clinical Trial Summary

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.

Clinical Trial 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 ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention Deficit Hyperactivity Disorder
  • Hyperkinesis
Clinical Trial Details
NCT number NCT00995085
Study type Interventional
Source Alcobra Ltd.
Contact
Status Completed
Phase Phase 1
Start date October 2009
Completion date October 2010
View Details
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