Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Metadoxine · 5 trials · 5 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
Pharmacokinetic calculations will be based on individual plasma concentrations of the blood sampling on Day 1 and Day 5. The following pharmacokinetic parameter will be calculated based on the plasma concentrations measured: Cmax Maximum concentration achieved
| 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) |
| MG01CI 1400 mg | EXPERIMENTAL | - |
| 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 |
| Metadoxine (MG01CI ) | DRUG | - |
| 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 |
Metadoxine is an investigational small molecule being studied for attention-deficit hyperactivity disorder (ADHD), including the predominantly inattentive type, in adults. It has also been evaluated in healthy adult subjects for pharmacokinetic studies. The drug is in clinical development and is not approved for any indication.
Metadoxine is being developed by Arcturus Therapeutics Holdings Inc. (NASDAQ: ARCT). The company is conducting clinical trials of the drug for ADHD in adult patients.
Metadoxine is in Phase 2 clinical development for ADHD. Two Phase 2 trials have been completed, and one Phase 1 pharmacokinetic study has also been completed. The drug remains investigational and has not received regulatory approval.
Metadoxine has been studied in three completed trials: NCT01243242, a Phase 2 efficacy and safety study in 120 adults with ADHD; NCT01685281, a Phase 2 dose comparison study in 36 adults with predominantly inattentive ADHD; and NCT01933997, a Phase 1 pharmacokinetic study in 16 healthy volunteers. All trials were conducted in Israel.
Yes, Metadoxine is also known as MG01CI. Clinical trials have used the name MG01CI to refer to the extended-release formulation of metadoxine being studied for ADHD in adults.