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study objectives are to compare the efficacy, safety and tolerability of two doses of MG01CI (1400 mg and 700 mg) to Placebo for the treatment of symptoms in adults diagnosed with PI-ADHD.
subjects will be randomly assigned in a 1:1:1 ratio to one of three treatment sequences as follows:
The study will consist of three periods: a screening period of up to one week, a 3-week double-blind treatment period, and a one-week safety follow-up period.
The purpose of this dose finding study is to compare two doses of MG01CI (1400 mg and 700 mg) to Placebo, in adult subjects with PI-ADHD. A crossover study design will allow evaluation of safety/tolerability and efficacy using validated computerized tests.
subjects will be randomly assigned in a 1:1:1 ratio to one of three treatment sequences as follows:
Overview of Study Visits
Screening Period:
Visit 1 - Screening/Baseline Visit (up to 7 days prior to dosing)
Treatment Period:
Visit 2 - Day 0 (Randomization Visit) Visit 3 - Day 7 ± 3 days Visit 4 - Day 14 ± 3 days Visit 5 - Day 21 ± 3 days
Follow-up period:
Visit 6 - Day 28 ± 3 days
Study duration for each subject will be up to 35 days .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metadoxine (MG01CI) 1400 mg | Active Comparator | single dose of Metadoxine (MG01CI) 1400 mg |
|
| Metadoxine (MG01CI) 700 mg | Active Comparator | Single dose of Metadoxine (MG01CI) 700 mg |
|
| Placebo | Placebo Comparator | Single dose of Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metadoxine (MG01CI) | Drug | MG01CI is an orally administered extended release formulation of metadoxine. Doses: 1400 mg and 700 mg and Placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in TOVA ADHD score from Screening/Baseline to 4 hours post-dose; | TOVA® is a computerized test that provides information about an individual's sustained attention, speed and consistency of responding, and behavioral self-regulation and executive functioning | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CANTAB sub-scores from baseline (Visit 2) to 4 hours post-dose; | The CANTAB is a computerized test assessing the key cognitive deficits present in ADHD. Sub-scores will include spatial working memory (SWM), stop signal task (SST), rapid visual information processing (RVP), and reaction time (RTI). | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | 5 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Iris Manor, Dr. | Geha Medical center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geha Medical Centre | Petah Tikva | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25295645 | Derived | Manor I, Rubin J, Daniely Y, Adler LA. Attention benefits after a single dose of metadoxine extended release in adults with predominantly inattentive ADHD. Postgrad Med. 2014 Sep;126(5):7-16. doi: 10.3810/pgm.2014.09.2795. |
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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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|
| Placebo | Drug | Placebo tablets will be similar in appearance (color and size) to the investigational product |
|
| Change in TOVA sub-scores from Screening/Baseline to 4 hours post-dose |
| 4 weeks |
| Number of participants who withdrew early from the study due to AE | 5 weeks |