Efficacy Study of Metadoxine SR Formulation in Attention Deficit Hyperactivity Disorder (ADHD) Subjects
NCT ID: NCT00995085
Last Updated: 2017-03-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
43 participants
INTERVENTIONAL
2009-10-31
2010-10-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Metadoxine SR
Metadoxine is a pyrolate salt of Pyridoxine
Extended Release Metadoxine
one oral 1400mg dose (2 tablets)
Interventions
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Extended Release Metadoxine
one oral 1400mg dose (2 tablets)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* diagnosed as ADHD
Exclusion Criteria
* head injured patients
* patients suffering from heart, lung, liver, kidney, intestinal, endocrine an neurological diseases and patients who are sensitive to vitamin B
18 Years
45 Years
ALL
No
Sponsors
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Alcobra Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Iris Manor, MD
Role: PRINCIPAL_INVESTIGATOR
Geha MC, Israel
Locations
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ADHD Unit, Geha MHC, Israel
Petah Tikva, , Israel
Countries
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Other Identifiers
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0012-09-GEH
Identifier Type: -
Identifier Source: org_study_id
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