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

Alcobra

Status and phase: Completed; Phase 1

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Drug: Extended Release Metadoxine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00995085

0012-09-GEH

Details and patient eligibility

About

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.

Full 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

Enrollment: 43 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

Metadoxine SR

Experimental group

Description:

Metadoxine is a pyrolate salt of Pyridoxine

Treatment:

Drug: Extended Release Metadoxine