Status:
COMPLETED
Efficacy Study of Metadoxine SR Formulation in Attention Deficit Hyperactivity Disorder (ADHD) Subjects
Lead Sponsor:
Alcobra Ltd.
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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...
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 sc...
Eligibility Criteria
Inclusion
- age 18-45
- diagnosed as ADHD
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00995085
Start Date
October 1 2009
End Date
October 1 2010
Last Update
March 13 2017
Active Locations (1)
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1
ADHD Unit, Geha MHC, Israel
Petah Tikva, Israel