drugset / Trial / NCT06854601

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

NCT06854601

Phase 3 Completed 333 enrolled Pharmasoft
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2019-07-13
Primary completion
2020-07-13
Completion
2020-07-13

Drugs

EvaluationDrugModalityDoseRoute
Comparator EMOXYPINE Small molecule 125 mg Oral