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

Inclusion Criteria:

1. Signed written informed consent for participation in the study from the patient'sparents.

2. Patients - boys and girls aged 6 to 12 years, inclusive, at the time of signing theinformed consent.

3. The child is raised by a father and/or mother.

4. The child is attending general education preschool or school institutions.

5. Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) established inaccordance with ICD-10 and DSM-5 criteria by a psychiatrist or neurologist,specifically:

• According to DSM-5:

1. Six or more symptoms of inattention persisting for at least 6 months and/or

2. Six or more symptoms of hyperactivity and impulsivity persisting for at least 6months

3. Symptoms are present in at least two areas of functioning (in preschool orschool and at home).

• And/or according to ICD-10:

4. Presence of at least 6 symptoms of inattention

5. Presence of at least 3 symptoms of hyperactivity

6. Presence of at least 1 symptom of impulsivity

7. Persisting for at least 6 months.

8. Moderate severity of ADHD as determined by the Clinical Global Impression - SeverityScale for ADHD (CGI-ADHD-S), not requiring hospitalization for treatment.

9. No more than two comorbid disorders that do not require additional pharmacotherapy,in the investigator's opinion, during the study period.

Exclusion Criteria:

Individuals who exhibit at least one of the following characteristics were not included in the study:

1. Increased sensitivity to the active substance of the investigational drug (ethylmethylhydroxypyridine succinate) and/or other components of the drug.

2. Liver dysfunction: ALT and/or AST ≥2.5 times the upper limit of normal (ULN) basedon screening lab results.

3. Kidney dysfunction: serum creatinine ≥1.5 times ULN based on screening lab results.

4. Intracranial pathology (including but not limited to: intracranial hemorrhage,tumors, infections, history of head trauma, excluding concussion).

5. Co-occurring autism spectrum disorders, Asperger syndrome.

6. Intellectual disability of any degree.

7. Other mental disorders, except for behavioral disorders (ICD-10 code F91).

8. Inability to discontinue psychotropic medications used for the treatment of ADHD.

9. Other somatic and/or neurological disorders requiring treatment with medicationsthat may affect the efficacy of the investigational drug (including but not limitedto: epilepsy, depression).

10. Use of nootropic, vasoactive medications, neuroprotectors, antioxidants, ormetabolic agents within 7 days or 5 half-lives (whichever is longer) prior torandomization.

11. Presence of any oncological disease in the medical history within 5 years prior tothe screening visit.

12. Participation in any other clinical study of drugs and/or medical devices within 3months prior to the screening visit and/or 5 half-lives, whichever is longer.

13. Inability or unwillingness to comply with protocol requirements, including forphysical, mental, or social reasons, in the opinion of the investigator.

14. Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.