Title

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

    Phase 1
  • Study Type

    Interventional
  • Intervention/Treatment

    metadoxine ...
  • Study Participants

    43
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.
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
Study Started
Oct 31
2009
Primary Completion
Oct 31
2010
Study Completion
Oct 31
2010
Results Posted
Jul 06
2011
Estimate
Last Update
Mar 13
2017

Drug Extended Release Metadoxine

one oral 1400mg dose (2 tablets)

  • Other names: Metadoxine, Metadoxil

Metadoxine SR Experimental

Metadoxine is a pyrolate salt of Pyridoxine

Criteria

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

Summary

Metadoxine SR

All Events

Event Type Organ System Event Term Metadoxine SR

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

Metadoxine SR

2.0
events

Age, Continuous

32.1
years (Mean)
Standard Deviation: 6.9

Region of Enrollment

Sex: Female, Male

Overall Study

Metadoxine SR

Drop/Withdrawal Reasons

Metadoxine SR