Efficacy Study of Metadoxine SR Formulation in Attention Deficit Hyperactivity Disorder (ADHD) Subjects
|Attention Deficit Hyperactivity Disorder||Drug: Extended Release Metadoxine||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Efficacy Study of Metadoxine SR Formulation in ADHD Subjects|
- Safety and Tolerability [ Time Frame: 24 hours after drug adminstration ]Subjects were evaluated for general safety and tolerablity measures, including number of AEs and AEs related (possibly or likely) to study drug
|Study Start Date:||October 2009|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Experimental: Metadoxine SR
Metadoxine is a pyrolate salt of Pyridoxine
Drug: Extended Release Metadoxine
one oral 1400mg dose (2 tablets)
Other Name: Metadoxine, Metadoxil
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00995085
|ADHD Unit, Geha MHC, Israel|
|Petach Tikva, Israel|
|Principal Investigator:||Iris Manor, MD||Geha MC, Israel|