NCT00995085

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

Efficacy Study of Metadoxine SR Formulation in ADHD Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Alcobra Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Extended Release Metadoxine	one oral 1400mg dose (2 tablets)

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2009-10-14
• Last updated: 2017-03-13
• Results posted: 2011-07-06

Locations

1 site across 1 country: Israel