At a glance
ClinicalIndex Comparison Record- ✓Children aged 6 to 12 years at time of informed consent
- ✓Diagnosis of ADHD per DSM-5 (≥6 symptoms inattention and/or ≥6 symptoms hyperactivity-impulsivity for ≥6 months, present in ≥2 settings) and/or ICD-10 criteria (≥6 inattention, ≥3 hyperactivity, ≥1 impulsivity, persisting ≥6 months)
- ✓Moderate severity ADHD on Clinical Global Impression – Severity Scale for ADHD (CGI-ADHD-S), not requiring hospitalization
- ✓No more than two comorbid disorders that do not require additional pharmacotherapy during study
- ✕Known hypersensitivity to ethylmethylhydroxypyridine succinate or other drug components
- ✕Autism spectrum disorder or Asperger syndrome
- ✕Intellectual disability of any degree
- ✕Other mental disorders (except behavioral disorders ICD-10 F91)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Double-blind, Randomized, Placebo-controlled Clinical Trial in Three Parallel Groups to Evaluate the Effectiveness and Safety of Mexidol® Film-coated Tablets, 125 mg (LLC 'NPK PHARMASOFT', Russia) in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Children Aged 6-12 Years With Various Dosing Regimens (MEGA).
In Brief
A Phase 3 clinical trial evaluating Mexidol, Placebo, and 1 other intervention for Attention Deficit Hyperactivity Disorder (ADHD) and Anxiety Disorders and Symptoms. Completed, enrolled 333 participants across 14 sites.
Detailed 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.
Study Details
Timeline
Interventions
125 mg tablets
Placebo tablets
Combination of Mexidol and Placebo