This study is a multisite, randomized, double-blind, placebo-controlled, phase 2/3 study of MG01CI (1400 mg daily) for 6 weeks compared with placebo in a 1:1 ratio of 300 adults with ADHD.
This study is a multisite, randomized, double-blind, placebo-controlled, phase 2/3 study of MG01CI (1400 mg once daily) for 6 weeks compared with placebo in a 1:1 ratio of 300 adults with ADHD. The study comprises a Screening Visit at which initial assessment will be made and then a Washout Period during which prospective subjects must discontinue ADHD medication for 14 days (for psychotropic medications other than fluoxetine) or for 28 days (for fluoxetine) before randomization into the study. The Washout Period is 14 days, but may be extended to 28 days for a fluoxetine washout. Subjects requiring either a 14-day or a 28-day Washout Period will have an Interim Visit (off drug) on or about Day -8 (Day -10 to Day -3) for CAARS-Inv assessment after the Washout Period. The Baseline CAARS Inv assessment will be conducted on Day 0. If there is a ≥25% change in the CAARS-Inv results between the Interim Visit (off drug) assessment and the Baseline assessment, or if the subject does not return for the Baseline CAARS-Inv assessment, the subject will not be randomized. For subjects not needing washout, if there is a ≥25% change in the CAARS-Inv results between the Screening Visit assessment and the Baseline assessment, or if the subject does not return for the Baseline CAARS-Inv assessment, the subject will not be randomized. Following the Washout Period for those requiring a washout, or following the Screening Visit for those subjects who do not require a washout, eligible subjects will undergo baseline assessments and be randomized on Day 0 to MG01CI 1400 mg or to matching placebo and begin the Double-blind Treatment Period. The Double-blind Treatment Period will be 6 weeks in duration. There will be a 2-week Follow-up Period after the last dose of study treatment or early termination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily
Placebo 1400 mg administered orally once daily
Sarkis Clinical Trials
Gainesville, Florida, United States
Miami Research
Change in Total ADHD Symptom Score With Adult Prompts of the Conners Adult ADHD Rating Scale:O-SV in ADHD Adults From Baseline to 6 Weeks
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.
Time frame: baseline, 6 weeks
Safety Evaluation of Treatment on the Basis of Percentage of Participants With Treatment Emergent Adverse Events
Safety assessments will be based on changes from Baseline of clinical AEs reported by the subject or observed by the Investigator and concomitant medication use, treatment adherence (eg, dropouts due to AEs)
Time frame: 6 weeks
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