Attention Deficit Hyperactivity Disorder
Conditions
Keywords
ADHD, ADD, TOVA, METADOXINE
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
Interventions
DRUGExtended Release Metadoxine
one oral 1400mg dose (2 tablets)
Sponsors
Alcobra Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Metadoxine SR Metadoxine is a pyrolate salt of Pyridoxine | 43 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Metadoxine SR |
|---|---|
| Age, Continuous | 32.1 years STANDARD_DEVIATION 6.9 |
| Region of Enrollment Israel | 43 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 38 |
| serious Total, serious adverse events | 0 / 38 |
Outcome results
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
Time frame: 24 hours after drug adminstration
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Metadoxine SR | Safety and Tolerability | 2 events |