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 Details — Status: Completed

Administrative data

• NCT number: NCT00995085
• Other study ID #: 0012-09-GEH
• Status: Completed
• Phase: Phase 1
• First received: October 13, 2009
• Last updated: April 27, 2014
• Start date: October 2009
• Est. completion date: October 2010

Study information

• Verified date: June 2011
• Source: Alcobra Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

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

Intervention

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

Locations

Country	Name	City	State
Israel	ADHD Unit, Geha MHC, Israel	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Alcobra Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability	Subjects were evaluated for general safety and tolerablity measures, including number of AEs and AEs related (possibly or likely) to study drug	24 hours after drug adminstration	Yes