NCT06854601

Safety and Efficacy of Mexidol® for ADHD in Children Aged 6-12

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).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 333 (actual)
• Sponsor: Pharmasoft · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Attention Deficit Hyperactivity Disorder (ADHD)
• Anxiety Disorders and Symptoms

Interventions

Type	Name	Description
DRUG	Mexidol	125 mg tablets
DRUG	Placebo	Placebo tablets
DRUG	Mexidol + Placebo	Combination of Mexidol and Placebo

Timeline

• Start date: 2019-07-13
• Primary completion: 2020-07-13
• Completion: 2020-07-13
• First posted: 2025-03-03
• Last updated: 2025-08-17
• Results posted: 2025-08-17

Locations

14 sites across 1 country: Russia