Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD ADD TOVA METADOXINE
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 43
Healthy volunteers: no

Brief 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

Arms:
arm 1: Metadoxine is a pyrolate salt of Pyridoxine

Interventions: intervention 1: Extended Release Metadoxine
Intervention descriptions: intervention 1: one oral 1400mg dose (2 tablets)

Protocol document: