Efficacy Study of Metadoxine SR Formulation in ADHD Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Alcobra Ltd.
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Safety and Tolerability
Study Overview
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:
- TOVA measures like response time , variability, omissions etc.
- Subtests from Wechsler: digit memory, digit-number signs etc
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Metadoxine SR
Metadoxine is a pyrolate salt of Pyridoxine
Intervention: Extended Release Metadoxine (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported