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MG01CI · 2 trials · 3 indications
To evaluate the efficacy of MG01CI (Metadoxine Extended-release) once daily compared with placebo in the treatment of symptoms of FXS in adults and adolescents as measured by the inattentive subscale of the Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale (ADHD RS-IV) (as rated by the investigator in a clinical interview of the parent/legal authorized guardian/consistent caregiver).
Primary efficacy endpoint: change from Baseline in the total ADHD symptom score with adult prompts of the CAARS-Inv. The CAARS is a scale to assess the presence and severity of ADHD symptoms and behaviors in adults. During an interview with the investigator, subject rates items pertaining to their behavior using a 4-point Likert-style format ranging from 0 ('Not at all') to 3 ('Very much). The scale measures ADHD symptoms across clinically significant domains using a 30 item questionnaire, while examining the manifestations of those symptoms. The scale includes an assessment of 9 inattentive symptoms (Subset A) and 9 hyperactive \& impulsive symptoms (Subset B). The total ADHD symptom score, Subset C (the sum of the inattentive symptom scores from Subset A and the hyperactive \& impulsive symptoms from Subset B) is the primary outcome measure. Scores of the scale for Subset C, comprised of scores from 18 questions,range from 0 (no ADHD symptoms) to 54, highest rating of ADHD symptoms.
| Arm | Type | Description |
|---|---|---|
| Metadoxine Immediate/Slow-release | EXPERIMENTAL | Flexed and fixed-dose Metadoxine Immediate/Slow-release 700 mg and 1400 mg administered orally once daily |
| Placebo | PLACEBO_COMPARATOR | Placebo tablet identical in appearance to study investigational product. Administered orally once daily |
| MG01CI (1400 mg) | EXPERIMENTAL | MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) Dose, route, and frequency: 1400 mg administered orally once daily |
| Name | Type | Description |
|---|---|---|
| MG01CI extended-release tablet | DRUG | Metadoxine, MG01CI extended-release tablet taken for 6 weeks treatment. Starting with a dose of 700 mg for 2 weeks followed by a 2 weeks of 1400 mg and then 2 weeks of 700 mg or 1400 mg. |
| MG01CI (1400 mg) | DRUG | MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily |
| placebo | DRUG | Placebo 1400 mg administered orally once daily |
Inclusion Criteria: 1. Subject is a man or a non-pregnant, non-lactating woman aged 15 to 55 years, inclusive, at the Randomization Visit. 2. Subject has Fragile X Syndrome with a molecular genetic confirmation of the full Fragile X Mental Retardation (FMR1) mutation (≥200 CGG repetitions). 3. Subj...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Supernus Pharmaceuticals, Inc. | SUPN | 1 | PHASE3 | SPN-812 |
MG01CI is an investigational small molecule being developed for the treatment of ADHD, specifically attention-deficit/hyperactivity disorder. It is currently in Phase 2 clinical development and has been studied in adults with ADHD, including the predominantly inattentive type.
MG01CI is being developed by Arcturus Therapeutics Holdings Inc., a biopharmaceutical company listed on the NASDAQ under the ticker symbol ARCT. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with ADHD.
MG01CI is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 clinical trial of MG01CI has been completed, evaluating its effects in adults with ADHD.
MG01CI has been studied in a Phase 2 clinical trial with the identifier NCT02059642. This was a 6-week, randomized, double-blind, placebo-controlled study of MG01CI 1400 mg in adults with ADHD, enrolling 300 participants across the United States and Israel.
MG01CI is a distinct investigational drug being developed by Arcturus Therapeutics. It is a small molecule intended for the treatment of ADHD, and its clinical trial compared it against placebo rather than against other active ADHD medications.