drugset / Trial / NCT06854601
Safety and Efficacy of Mexidol® for ADHD in Children Aged 6-12
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | EMOXYPINE | Small molecule | 125 mg | Oral |