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 1Lead Sponsor
Alcobra Ltd.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
Attention Deficit Hyperactivity DisorderIntervention/Treatment
pyridoxine ...Study Participants
43This 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
one oral 1400mg dose (2 tablets)
Metadoxine is a pyrolate salt of Pyridoxine
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
| Event Type | Organ System | Event Term | Metadoxine SR |
|---|
Subjects were evaluated for general safety and tolerablity measures, including number of AEs and AEs related (possibly or likely) to study drug
