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

NCT06854601 | Completed Phase 3 Results

• 2 other identifiers: MexidolMEGA2020PHS-ADHD-002-MEX-TAB
• Study Type: interventional
• Target: 333
• Locations: 1 country
• Sites: 14

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  The Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV) is a 90-question self-report inventory designed to measure attention deficit hyperactivity disorder and oppositional defiant disorder symptoms in children and young adults. The SNAP-IV is based on a 0 to 3 rating scale: Not at all = 0, Just a little = 1, Often = 2, and Very often = 3. The questions measure different domains of ADHD and ODD. Subscale scores are calculated by summing the scores on the subset and dividing by the number of items in the subset. The main criterion for the treatment efficacy was the mean change in the total score on the "inattention" and "hyperactivity/impulsivity" subscales after 6 weeks of therapy. A conclusion of superiority of Mexidol over placebo can be made if the upper limit of the 95% confidence interval for the difference in mean changes is negative. 55 point scale: min value 0, max value 54, higher scores mean a worse outcome.

  Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day 1 = Randomization Visit)

Secondary Outcomes (10)

• Average Change in the the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale "Inattention"

  Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 1 Day 0 = Screening)

• Average Change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale "Hyperactivity/Impulsivity"

  Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 1 Day 0 = Screening)

• Average Change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale "Oppositional Defiant Disorder"

  Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 1 Day 0 = Screening)

• Average Change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale "Connors Index"

  Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 1 Day 0 = Screening)

• Average Change in the Spence Children's Anxiety Scale - Parent Version (SCAS-Parent) Score

  Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day 1 = Randomization Visit)

Study Arms (3)

Main (Mexidol) + Control (Placebo)

OTHER

Participants received Mexidol 125 mg 1 tablet orally once a day and Mexidol Placebo matching Mexidol 125 mg 1 tablet orally once a day for 42 days.

Drug: Mexidol + Placebo

Main (Mexidol)

ACTIVE COMPARATOR

Participants received Mexidol 125 mg 1 tablet orally twice a day for 42 days.

Drug: Mexidol

Control (Placebo)

PLACEBO COMPARATOR

Participants received Mexidol Placebo matching Mexidol 125 mg 1 tablet orally twice a day for 42 days.

Drug: Placebo

Interventions

Mexidol DRUG

125 mg tablets

Main (Mexidol)

Placebo DRUG

Placebo tablets

Control (Placebo)

Mexidol + Placebo DRUG

Combination of Mexidol and Placebo

Main (Mexidol) + Control (Placebo)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Signed written informed consent for participation in the study from the patient's parents.
• Patients - boys and girls aged 6 to 12 years, inclusive, at the time of signing the informed consent.
• The child is raised by a father and/or mother.
• The child is attending general education preschool or school institutions.
• 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:
• Six or more symptoms of inattention persisting for at least 6 months and/or
• Six or more symptoms of hyperactivity and impulsivity persisting for at least 6 months
• Symptoms are present in at least two areas of functioning (in preschool or school and at home).
• \- And/or according to ICD-10:
• Presence of at least 6 symptoms of inattention
• Presence of at least 3 symptoms of hyperactivity
• Presence of at least 1 symptom of impulsivity
• Persisting for at least 6 months.
• Moderate severity of ADHD as determined by the Clinical Global Impression - Severity Scale for ADHD (CGI-ADHD-S), not requiring hospitalization for treatment.

You may not qualify if:

• Individuals who exhibit at least one of the following characteristics were not included in the study:
• Increased sensitivity to the active substance of the investigational drug (ethylmethylhydroxypyridine succinate) and/or other components of the drug.
• Liver dysfunction: ALT and/or AST ≥2.5 times the upper limit of normal (ULN) based on screening lab results.
• Kidney dysfunction: serum creatinine ≥1.5 times ULN based on screening lab results.
• Intracranial pathology (including but not limited to: intracranial hemorrhage, tumors, infections, history of head trauma, excluding concussion).
• Co-occurring autism spectrum disorders, Asperger syndrome.
• Intellectual disability of any degree.
• Other mental disorders, except for behavioral disorders (ICD-10 code F91).
• Inability to discontinue psychotropic medications used for the treatment of ADHD.
• 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).
• Use of nootropic, vasoactive medications, neuroprotectors, antioxidants, or metabolic agents within 7 days or 5 half-lives (whichever is longer) prior to randomization.
• Presence of any oncological disease in the medical history within 5 years prior to the screening visit.
• 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.
• Inability or unwillingness to comply with protocol requirements, including for physical, mental, or social reasons, in the opinion of the investigator.
• Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

Sponsors & Collaborators

• Pharmasoft: lead

Study Sites (14)

State Autonomous Healthcare Institution of the Sverdlovsk Region "Multispecialty Clinical Medical Center 'Bonum'

Yekaterinburg, Ural Region, 620075, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" Ministry of Health of the Russian Federation

Kazan', 420012, Russia

Location

State Budgetary Healthcare Institution "Specialized Clinical Psychiatric Hospital №1" of the Ministry of Health of the Krasnodar Territory

Krasnodar, 350007, Russia

Location

Limited Liability Company "Center for Professional Therapy"

Krasnodar, 350051, Russia

Location

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

Moscow, 117997, Russia

Location

State Budgetary Healthcare Institution of the City of Moscow "Scientific and Practical Center for Child Psychoneurology of the Moscow Department of Healthcare"

Moscow, 129344, Russia

Location

Limited Liability Company "NizhMedClinic"

Nizhny Novgorod, 603006, Russia

Location

State Budgetary Healthcare Institution "Orenburg Regional Clinical Psychiatric Hospital №1"

Orenburg, 460015, Russia

Location

Limited Liability Company "Medical Technologies"

Saint Petersburg, 192148, Russia

Location

Limited Liability Company "DNA Research Center"

Saratov, 410005, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Tver State Medical University" Ministry of Health of the Russian Federation

Tver', 170100, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Tyumen State Medical University" Ministry of Health of the Russian Federation

Tyumen, 625000, Russia

Location

State Healthcare Institution "Central Clinical Medical-Sanitary Unit named after Honored Doctor of Russia V.A. Egorov"

Ulyanovsk, 432026, Russia

Location

Limited Liability Company "European Medical Center 'UGMK-Health'"

Yekaterinburg, 620144, Russia

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Anxiety Disorders; Spasm; Oppositional Defiant Disorder; Neurodevelopmental Disorders; Impulsive Behavior

Interventions

emoxypine succinate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Mental Disorders; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Results Point of Contact

• Title: Y.E. Meshcherskiy, Medical Director
• Organization: Pharmasoft

meshcherskiy_y@pharmasoft.ru

+ 7 (495) 626-47- 55

Study Officials

• Polina S. Nikiforova, MD

  State Autonomous Healthcare Institution of the Sverdlovsk Region "Multispecialty Clinical Medical Center 'Bonum'

  PRINCIPAL INVESTIGATOR

• Nikolay N. Zavadenko, Dr.Med.Sci, Prof.

  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

  PRINCIPAL INVESTIGATOR

• Olga V. Khaletskaya, Dr.Med.Sci, Prof.

  Limited Liability Company "NizhMedClinic"

  PRINCIPAL INVESTIGATOR

• Elena V. Levitina, Dr.Med.Sci, Prof.

  Federal State Budgetary Educational Institution of Higher Education "Tyumen State Medical University" Ministry of Health of the Russian Federation,

  PRINCIPAL INVESTIGATOR

• Irina N. Vakula, MD

  Limited Liability Company "Center for Professional Therapy"

  PRINCIPAL INVESTIGATOR

• Olga S. Panina, Cand.Med.Sci, MD

  Limited Liability Company "DNA Research Center"

  PRINCIPAL INVESTIGATOR

• Dina D. Gainetdinova, Dr.Med.Sci, Prof.

  Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" Ministry of Health of the Russian Federation

  PRINCIPAL INVESTIGATOR

• Anna N. Platonova, Cand.Med.Sci, MD

  State Budgetary Healthcare Institution of the City of Moscow "Scientific and Practical Center for Child Psychoneurology of the Moscow Department of Healthcare"

  PRINCIPAL INVESTIGATOR

• Yuliya O. Boychevskaya, MD

  State Budgetary Healthcare Institution "Specialized Clinical Psychiatric Hospital №1" of the Ministry of Health of the Krasnodar Territory

  PRINCIPAL INVESTIGATOR

• Natalya E. Maksimova, Cand.Med.Sci, MD

  Federal State Budgetary Educational Institution of Higher Education "Tver State Medical University" Ministry of Health of the Russian Federation

  PRINCIPAL INVESTIGATOR

• Elena M. Kryukova, MD

  State Budgetary Healthcare Institution "Orenburg Regional Clinical Psychiatric Hospital №1"

  PRINCIPAL INVESTIGATOR

• Elmira S. Sagutdinova, Cand.Med.Sci, MD

  Limited Liability Company "European Medical Center 'UGMK-Health'"

  PRINCIPAL INVESTIGATOR

• Anna S. Nezabudkina, MD

  Limited Liability Company "Medical Technologies"

  PRINCIPAL INVESTIGATOR

• Viktor V. Mashin, Dr.Med.Sci, Prof.

  State Healthcare Institution "Central Clinical Medical-Sanitary Unit named after Honored Doctor of Russia V.A. Egorov"

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, double-blind, randomized, placebo-controlled clinical trial in three parallel groups to evaluate efficacy and safety

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: March 3, 2025
• Study Start: July 13, 2019
• Primary Completion: July 13, 2020
• Study Completion: July 13, 2020
• Last Updated: August 17, 2025
• Results First Posted: August 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (14)