Efficacy Study of Metadoxine SR Formulation in Attention Deficit Hyperactivity Disorder (ADHD) Subjects
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- Registration Number
- NCT00995085
- Lead Sponsor
- Alcobra Ltd.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
- age 18-45
- diagnosed as ADHD
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Metadoxine SR Extended Release Metadoxine Metadoxine is a pyrolate salt of Pyridoxine
- Primary Outcome Measures
Name Time Method Safety and Tolerability 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
ADHD Unit, Geha MHC, Israel
🇮🇱Petach Tikva, Israel