Safety and Efficacy of Mexidol® for ADHD in Children Aged 6-12 (NCT06854601) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy of Mexidol® for ADHD in Children Aged 6-12
Russia333 participantsStarted 2019-07-13
Plain-language summary
The primary objective of this study was to evaluate the efficacy and safety of Mexidol® film-coated tablets (125 mg) compared to a placebo in children aged 6 to 12 years with Attention Deficit Hyperactivity Disorder (ADHD). This multicenter, prospective, double-blind, randomized trial included 333 children who met the diagnostic criteria established by the International Classification of Diseases (ICD-10) and the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Participants received either Mexidol or placebo for 42 days, and various efficacy and safety parameters were assessed.
Who can participate
Age range6 Years – 12 Years
SexALL
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Inclusion criteria
âś“. Signed written informed consent for participation in the study from the patient's parents.
âś“. Patients - boys and girls aged 6 to 12 years, inclusive, at the time of signing the informed consent.
âś“. The child is raised by a father and/or mother.
âś“. The child is attending general education preschool or school institutions.
âś“. Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) established in accordance with ICD-10 and DSM-5 criteria by a psychiatrist or neurologist, specifically:
âś“. Six or more symptoms of inattention persisting for at least 6 months and/or
âś“. Six or more symptoms of hyperactivity and impulsivity persisting for at least 6 months
âś“. Symptoms are present in at least two areas of functioning (in preschool or school and at home).
Exclusion criteria
âś•. Increased sensitivity to the active substance of the investigational drug (ethylmethylhydroxypyridine succinate) and/or other components of the drug.
What they're measuring
1
The Average Change in the Total Score Across the "Inattention" and "Hyperactivity/Impulsivity" Subscales of the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV) After 6 Weeks of Therapy Compared to the Baseline Level.
Timeframe: Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day 1 = Randomization Visit)