Clinical trial NCT06854601: Safety and Efficacy of Mexidol® for ADHD in Children Aged 6-12
Official title: 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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Anxiety Disorders and Symptoms
Keywords: Mexidol
hyperactivity
ADHD
oppositional defiant disorder
inattention
Neurodevelopmental disorders
Hyperactive behavior
Impulsive behavior
anxiety
Lead sponsor: Pharmasoft
Sponsor class: INDUSTRY
First posted: 2025-03-03
Enrollment: 333
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, double-blind, randomized, placebo-controlled clinical trial in three parallel groups to evaluate efficacy and safety
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Signed written informed consent for participation in the study from the patient's parents.
2. Patients - boys and girls aged 6 to 12 years, inclusive, at the time of signing the informed 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 in accordance 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 6 months
   3. Symptoms are present in at least two areas of functioning (in preschool or school 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.
6. Moderate severity of ADHD as determined by the Clinical Global Impression - Severity Scale for ADHD (CGI-ADHD-S), not requiring hospitalization for treatment.
7. 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) based on 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 medications that may affect the efficacy of the investigational drug (including but not limited to: epilepsy, depression).
10. Use of nootropic, vasoactive medications, neuroprotectors, antioxidants, or metabolic agents within 7 days or 5 half-lives (whichever is longer) prior to randomization.
11. Presence of any oncological disease in the medical history within 5 years prior to the screening visit.
12. Participation in any other clinical study of drugs and/or medical devices within 3 months prior to the screening visit and/or 5 half-lives, whichever is longer.
13. Inability or unwillingness to comply with protocol requirements, including for physical, mental, or social reasons, in the opinion of the investigator.
14. Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

Primary outcomes:
measure: The average change in the total score across the "inattention" and "hyperactivity/impulsivity" subscales of the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV) after 6 weeks of therapy compared to the baseline level.
timeFrame: after 6 weeks of therapy compared to the baseline level
Secondary outcomes:
measure: Average change in the the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), subscale "Inattention"
timeFrame: after 6 weeks of therapy compared to baseline levels
measure: Average change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), subscale "Hyperactivity/Impulsivity"
timeFrame: after 6 weeks of therapy compared to baseline levels
measure: Average change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), subscale "Oppositional Defiant Disorder"
timeFrame: after 6 weeks of therapy compared to baseline levels
measure: Average change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), subscale "Connors Index"
timeFrame: after 6 weeks of therapy compared to baseline levels
measure: Average change in the Spence Children's Anxiety Scale - Parent Version (SCAS-Parent) score
timeFrame: after 6 weeks of therapy compared to baseline levels
measure: Average change in the Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) score
timeFrame: after 6 weeks of therapy compared to baseline levels
measure: Assessment using the Clinical Global Impressions for Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S) scale
timeFrame: after 6 weeks of therapy compared to baseline levels
measure: Assessment using the Pediatric Migraine Disability Assessment (PedMIDAS) questionnaire
timeFrame: during 6 weeks of therapy
measure: Assessment using the Clinical Global Impressions Scale for Improvement (CGI-I)
timeFrame: after 6 weeks of therapy compared to baseline levels
Other outcomes:
Locations:
city: Yekaterinburg
country: Russian Federation
facility: State Autonomous Healthcare Institution of the Sverdlovsk Region "Multispecialty Clinical Medical Center 'Bonum'
state: Ural region
city: Kazan
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" Ministry of Health of the Russian Federation
city: Krasnodar
country: Russian Federation
facility: State Budgetary Healthcare Institution "Specialized Clinical Psychiatric Hospital №1" of the Ministry of Health of the Krasnodar Territory
city: Krasnodar
country: Russian Federation
facility: Limited Liability Company "Center for Professional Therapy"
city: Moscow
country: Russian Federation
facility: Federal State Autonomous Educational Institution of Higher Education "Russian National Research Medical University named after N.I. Pirogov" Ministry of Health of the Russian Federation
city: Moscow
country: Russian Federation
facility: State Budgetary Healthcare Institution of the City of Moscow "Scientific and Practical Center for Child Psychoneurology of the Moscow Department of Healthcare"
city: Nizhny Novgorod
country: Russian Federation
facility: Limited Liability Company "NizhMedClinic"
city: Orenburg
country: Russian Federation
facility: State Budgetary Healthcare Institution "Orenburg Regional Clinical Psychiatric Hospital №1"
city: Saint Petersburg
country: Russian Federation
facility: Limited Liability Company "Medical Technologies"
city: Saratov
country: Russian Federation
facility: Limited Liability Company "DNA Research Center"
city: Tver
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Education "Tver State Medical University" Ministry of Health of the Russian Federation
city: Tyumen
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Education "Tyumen State Medical University" Ministry of Health of the Russian Federation
city: Ulyanovsk
country: Russian Federation
facility: State Healthcare Institution "Central Clinical Medical-Sanitary Unit named after Honored Doctor of Russia V.A. Egorov"
city: Yekaterinburg
country: Russian Federation
facility: Limited Liability Company "European Medical Center 'UGMK-Health'"
Study officials:
affiliation: State Autonomous Healthcare Institution of the Sverdlovsk Region "Multispecialty Clinical Medical Center 'Bonum'
name: Polina S. Nikiforova, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal State Autonomous Educational Institution of Higher Education "Russian National Research Medical University named after N.I. Pirogov" Ministry of Health of the Russian Federation
name: Nikolay N. Zavadenko, Dr.Med.Sci, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Limited Liability Company "NizhMedClinic"
name: Olga V. Khaletskaya, Dr.Med.Sci, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal State Budgetary Educational Institution of Higher Education "Tyumen State Medical University" Ministry of Health of the Russian Federation,
name: Elena V. Levitina, Dr.Med.Sci, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Limited Liability Company "Center for Professional Therapy"
name: Irina N. Vakula, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Limited Liability Company "DNA Research Center"
name: Olga S. Panina, Cand.Med.Sci, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" Ministry of Health of the Russian Federation
name: Dina D. Gainetdinova, Dr.Med.Sci, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: State Budgetary Healthcare Institution of the City of Moscow "Scientific and Practical Center for Child Psychoneurology of the Moscow Department of Healthcare"
name: Anna N. Platonova, Cand.Med.Sci, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: State Budgetary Healthcare Institution "Specialized Clinical Psychiatric Hospital №1" of the Ministry of Health of the Krasnodar Territory
name: Yuliya O. Boychevskaya, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal State Budgetary Educational Institution of Higher Education "Tver State Medical University" Ministry of Health of the Russian Federation
name: Natalya E. Maksimova, Cand.Med.Sci, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: State Budgetary Healthcare Institution "Orenburg Regional Clinical Psychiatric Hospital №1"
name: Elena M. Kryukova, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Limited Liability Company "European Medical Center 'UGMK-Health'"
name: Elmira S. Sagutdinova, Cand.Med.Sci, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Limited Liability Company "Medical Technologies"
name: Anna S. Nezabudkina, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: State Healthcare Institution "Central Clinical Medical-Sanitary Unit named after Honored Doctor of Russia V.A. Egorov"
name: Viktor V. Mashin, Dr.Med.Sci, Prof.
role: PRINCIPAL_INVESTIGATOR
References: