Overview

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

Status:
COMPLETED
Trial end date:
2020-07-13
Target enrollment:
Participant gender:
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.
Phase:
PHASE3
Details
Lead Sponsor:
Pharmasoft
Treatments:
emoxypine succinate