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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metadoxine SR | Experimental | Metadoxine is a pyrolate salt of Pyridoxine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended Release Metadoxine | Drug | one oral 1400mg dose (2 tablets) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Subjects were evaluated for general safety and tolerablity measures, including number of AEs and AEs related (possibly or likely) to study drug | 24 hours after drug adminstration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Iris Manor, MD | Geha MC, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ADHD Unit, Geha MHC, Israel | Petah Tikva | Israel |
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| ID | Title | Description |
|---|---|---|
| FG000 | Metadoxine SR | Metadoxine is a pyrolate salt of Pyridoxine |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Metadoxine SR | Metadoxine is a pyrolate salt of Pyridoxine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety and Tolerability | Subjects were evaluated for general safety and tolerablity measures, including number of AEs and AEs related (possibly or likely) to study drug | Posted | Dec 2010 | Number | events | 24 hours after drug adminstration |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metadoxine SR | Metadoxine is a pyrolate salt of Pyridoxine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tiredness | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Rubin, MD, MBA | Alcobra Inc | 610-504-7814 | jrubin@alcobra-pharma.com |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C037845 | metadoxine |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 38 |
| 2 |
| 38 |
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