Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Metadoxine (MG01CI )
Metadoxine · 4 trials · 4 indications
Frequency of treatment emergent adverse events (AEs). Frequency of subjects who withdrew early from the study due to AE.
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
The primary efficacy endpoint is the difference in change (decrease) in CAARS (Total ADHD Symptoms Score) between the study groups. The CAARS assess the presence and severity of ADHD symptoms and behaviors in adults. Respondents are asked to report their own experiences by rating items pertaining to their behavior/problems using a 4-point Likert-style format ranging from 0 ('Not at all', 'never') to 3 ('Very much', 'very frequently'). The scale measures ADHD symptoms using a 30-item questionnaire.Total score is the sum of all the items ,min=30 Max=90
| Arm | Type | Description |
|---|---|---|
| MDX (metadoxine extended release) | EXPERIMENTAL | Route of administration: oral The dose of MDX (approximately 14-22 mg/kg) will be determined by the subject's weight at the baseline visit as follows: * 40-49 kg 700 mg consisting of a 700 mg tablet * 50-64 kg 1050 mg consisting of a 700 mg tablet, a 350 mg tablet * 65-100 kg 1400 mg consisting of two 700 mg tablets |
| placebo | PLACEBO_COMPARATOR | Placebo tablets will be similar in appearance (color and size) to the investigational product |
| 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 |
| METADOXINE | EXPERIMENTAL | Eligible subjects will be randomly assigned to receive MG01CI (1,400 mg) |
| Metadoxine SR | EXPERIMENTAL | Metadoxine is a pyrolate salt of Pyridoxine |
| Name | Type | Description |
|---|---|---|
| Metadoxine extended release | DRUG | MG01CI |
| Placebo | DRUG | Inactive drug |
| Metadoxine (MG01CI) | DRUG | MG01CI is an orally administered extended release formulation of metadoxine. Doses: 1400 mg and 700 mg and Placebo |
| Extended Release Metadoxine | DRUG | one oral 1400mg dose (2 tablets) |
Inclusion Criteria: 1. Adolescent males and females, 13-17 years old, inclusive, at screening visit, with visible axillary hair. 2. Diagnosed with predominantly inattentive ADHD based on DSM V criteria for ADHD as assessed by the Adolescent ADHD Clinician Diagnostic Scale (Adol-CDS V1.2). 3. Clinic...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Supernus Pharmaceuticals, Inc. | SUPN | 1 | PHASE3 | SPN-812 |
| Axsome Therapeutics, Inc. | AXSM | 3 | PHASE3 | Solriamfetol |
Metadoxine is being developed for the treatment of attention-deficit hyperactivity disorder (ADHD), including ADHD Predominantly Inattentive Type, in adults. It is an investigational small molecule in Phase 2 clinical development and is not approved for marketing.
Metadoxine is being developed by Arcturus Therapeutics Holdings Inc., which trades on the Nasdaq under the ticker ARCT. The company is advancing the asset for ADHD indications in adult patients.
Metadoxine is in Phase 2 clinical development for ADHD. It has completed Phase 2 trials but has not been approved by the FDA or any other regulatory authority. It remains an investigational drug.
Metadoxine has been studied in two completed Phase 2 trials: NCT01243242, which enrolled 120 adults with ADHD, and NCT01685281, which enrolled 36 adults with ADHD Predominantly Inattentive Type. Both were randomized, double-blind, placebo-controlled studies conducted in Israel.
Yes, Metadoxine is also known as MG01CI, and the extended-release formulation is referred to as Metadoxine (MG01CI). These names refer to the same investigational small molecule being developed by Arcturus Therapeutics for ADHD.