Attention Deficit Hyperactivity Disorder (ADHD)Phase 3MEGANCT06854601
Safety and Efficacy of Mexidol® for ADHD in Children Aged 6-12
A Phase 3 study testing Mexidol in people with Attention Deficit Hyperactivity Disorder (ADHD) and Anxiety Disorders and Symptoms, run by Pharmasoft at 14 sites in Russia.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD), Anxiety Disorders and Symptoms
- What is being tested?
- Mexidol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 333 participants
- Where
- 14 sitesRussia
- Study dates
- 13 Jul 2019to 13 Jul 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
Show all 16Show fewer
- 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.
- No more than two comorbid disorders that do not require additional pharmacotherapy, in the investigator's opinion, during the study period.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Russia14 sites
Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" Ministry of Health of the Russian Federation
Kazan', 420012
State Budgetary Healthcare Institution "Specialized Clinical Psychiatric Hospital №1" of the Ministry of Health of the Krasnodar Territory
Krasnodar, 350007
Limited Liability Company "Center for Professional Therapy"
Krasnodar, 350051
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
State Budgetary Healthcare Institution of the City of Moscow "Scientific and Practical Center for Child Psychoneurology of the Moscow Department of Healthcare"
Moscow, 129344
Limited Liability Company "NizhMedClinic"
Nizhny Novgorod, 603006
State Budgetary Healthcare Institution "Orenburg Regional Clinical Psychiatric Hospital №1"
Orenburg, 460015
Limited Liability Company "Medical Technologies"
Saint Petersburg, 192148
Limited Liability Company "DNA Research Center"
Saratov, 410005
Federal State Budgetary Educational Institution of Higher Education "Tver State Medical University" Ministry of Health of the Russian Federation
Tver', 170100
Federal State Budgetary Educational Institution of Higher Education "Tyumen State Medical University" Ministry of Health of the Russian Federation
Tyumen, 625000
State Healthcare Institution "Central Clinical Medical-Sanitary Unit named after Honored Doctor of Russia V.A. Egorov"
Ulyanovsk, 432026
State Autonomous Healthcare Institution of the Sverdlovsk Region "Multispecialty Clinical Medical Center 'Bonum'
Yekaterinburg, Ural Region, 620075
Limited Liability Company "European Medical Center 'UGMK-Health'"
Yekaterinburg, 620144
About this study
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).
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.
- Being tested
- Mexidol, Placebo, Mexidol + Placebo
- Keywords
- Mexidol, hyperactivity, ADHD, oppositional defiant disorder, inattention, Neurodevelopmental disorders, Hyperactive behavior, Impulsive behavior, anxiety
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Anxiety Disorders, Spasm, Oppositional Defiant Disorder, Neurodevelopmental Disorders, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MexidolDrug
125 mg tablets
PlaceboDrug
Placebo tablets
Mexidol + PlaceboDrug
Combination of Mexidol and Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Mexidol + Placebo |
| Main (Mexidol) | Active comparator | Participants received Mexidol 125 mg 1 tablet orally twice a day for 42 days. Receives: Drug: Mexidol |
| Control (Placebo) | Placebo comparator | Participants received Mexidol Placebo matching Mexidol 125 mg 1 tablet orally twice a day for 42 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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"
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 (ADHD) and oppositional defiant disorder (ODD) 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 on the SNAP-IV are calculated by summing the scores on the subset and dividing by the number of items in the subset. The score for any subset is expressed as the Average Rating-Per-Item. 28 point scale: min value 0, max value 27, higher scores mean a worse outcome.
Measured: 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"
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 (ADHD) and oppositional defiant disorder (ODD) 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 on the SNAP-IV are calculated by summing the scores on the subset and dividing by the number of items in the subset. The score for any subset is expressed as the Average Rating-Per-Item. 28 point scale: min value 0, max value 27, higher scores mean a worse outcome.
Measured: 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"
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 (ADHD) and oppositional defiant disorder (ODD) 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 on the SNAP-IV are calculated by summing the scores on the subset and dividing by the number of items in the subset. The score for any subset is expressed as the Average Rating-Per-Item. 25 point scale: min value 0, max value 24, higher scores mean a worse outcome.
Measured: 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"
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 (ADHD) and oppositional defiant disorder (ODD) 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 on the SNAP-IV are calculated by summing the scores on the subset and dividing by the number of items in the subset. The score for any subset is expressed as the Average Rating-Per-Item. 31 point scale: min value 0, max value 30, higher scores mean a worse outcome.
Measured: 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
The Spence Children's Anxiety Scale - Parent Version (SCAS-Parent) is a 39-item parent report measure designed to assess anxiety symptoms in children. Built upon contemporary diagnostic frameworks, the SCAS-Parent evaluates six distinct domains of anxiety that align with clinical diagnostic categories. Each question on the test addresses the frequency of certain anxiety symptoms, measured on a 0-3 scale from "never", "sometimes", "often", to "always". SCAS-Parent scores consist of a total raw score (range from 0 to 114) and six sub-scale scores, with higher scores indicating greater severity of anxiety symptoms. 124 point scale: min value 0, max value 123, higher scores mean a worse outcome.
Measured: Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day 1 = Randomization Visit)
Average Change in the Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Score
The Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) is an 18-question inventory used to aid in the diagnosis of attention deficit hyperactivity disorder (ADHD) in children. Each question measures the frequency of the behavior on a 0-3 scale from "rarely or never", "sometimes", "often", to "very often". The questionnaire is intended to be filled out by parents and teachers. Higher scores indicate greater severity of ADHD symptoms. 55 point scale: min value 0, max value 54, higher scores mean a worse outcome.
Measured: Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day 1 = Randomization Visit)
Assessment Using the Clinical Global Impressions for Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S) Scale
The Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) is a clinician-rated scale used to assess the severity of Attention Deficit Hyperactivity Disorder (ADHD) symptoms. This tool is part of the Clinical Global Impressions (CGI) scales. It typically consists of a single item that rates the severity of ADHD on a 7-point scale, ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). 7 point scale: min value 1, max value 7, higher scores mean a worse outcome.
Measured: Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day 1 = Randomization Visit)
Assessment Using the Clinical Global Impressions Scale for Improvement (CGI-I)
The Clinical Global Impressions (CGI) Scale is a standardized assessment tool used to rate the severity of illness, change over time, and efficacy of medication. It consists of 3 subscales. The subscale Clinical Global Impression-Improvement (CGI-I) is a 7-point scale that assesses how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention, and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. 7 point scale: min value 1, max value 7, higher scores mean a worse outcome.
Measured: Visit 5 (after 6 weeks of therapy) compared to the baseline level (before treatment)
Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Days
The Pediatric Migraine Disability Assessment questionnaire (PedMIDAS) is used to assess the impact of headaches on school performance (three questions), activities at home (one question on homework or chores), and social and/or sports functions (two questions). The PedMIDAS is scored by summing the answers across the six questions. The frequency and severity are not scored but can be used for clinical reference. PedMIDAS score range from 0 to 10 indicates little to none disability grade, score range from 11 to 30 indicates mild disability grade, score range from 31 to 50 indicates moderate disability grade and score range greater than 50 indicates severe disability grade. Min value 0, max value 240, higher scores mean a worse outcome.
Measured: Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day1 = Randomization Visit)
Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Headache Severity
The Pediatric Migraine Disability Assessment questionnaire (PedMIDAS) is used to assess the impact of headaches on school performance (three questions), activities at home (one question on homework or chores), and social and/or sports functions (two questions). The PedMIDAS is scored by summing the answers across the six questions. The frequency and severity are not scored but can be used for clinical reference. PedMIDAS score range from 0 to 10 indicates little to none disability grade, score range from 11 to 30 indicates mild disability grade, score range from 31 to 50 indicates moderate disability grade and score range greater than 50 indicates severe disability grade. Min value 0, max value 240, higher scores mean a worse outcome.
Measured: Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day1 = Randomization Visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start13 Jul 2019
- Primary completion13 Jul 2020
- Study completion13 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, double-blind, randomized, placebo-controlled clinical trial in three parallel groups to evaluate efficacy and safety
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmasoft
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Polina S. Nikiforova, MD, Principal investigator, State Autonomous Healthcare Institution of the Sverdlovsk Region "Multispecialty Clinical Medical Center 'Bonum'Nikolay N. Zavadenko, Dr.Med.Sci, Prof., Principal investigator, Federal State Autonomous Educational Institution of Higher Education "Russian National Research Medical University named after N.I. Pirogov" Ministry of Health of the Russian FederationOlga V. Khaletskaya, Dr.Med.Sci, Prof., Principal investigator, Limited Liability Company "NizhMedClinic"Elena V. Levitina, Dr.Med.Sci, Prof., Principal investigator, Federal State Budgetary Educational Institution of Higher Education "Tyumen State Medical University" Ministry of Health of the Russian Federation,Irina N. Vakula, MD, Principal investigator, Limited Liability Company "Center for Professional Therapy"Olga S. Panina, Cand.Med.Sci, MD, Principal investigator, Limited Liability Company "DNA Research Center"Dina D. Gainetdinova, Dr.Med.Sci, Prof., Principal investigator, Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" Ministry of Health of the Russian FederationAnna N. Platonova, Cand.Med.Sci, MD, Principal investigator, State Budgetary Healthcare Institution of the City of Moscow "Scientific and Practical Center for Child Psychoneurology of the Moscow Department of Healthcare"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854601
- Sponsor's protocol ID
- MexidolMEGA2020
- Other IDs
- PHS-ADHD-002-MEX-TAB
- Acronym
- MEGA
- Status last verified
- Jul 2025
- First submitted
- 11 Feb 2025
- Last updated
- 17 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT06854601
- Acronym / sponsor ID
- MEGA / MexidolMEGA2020
- Keywords
- Mexidol, hyperactivity, ADHD, oppositional defiant disorder, inattention, Neurodevelopmental disorders, Hyperactive behavior, Impulsive behavior
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- PharmasoftIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2019 (actual)
- Primary completion
- 13 Jul 2020 (actual)
- Study completion
- 13 Jul 2020 (actual)
- First posted
- 3 Mar 2025 (actual)
- Results
- Posted 17 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Multicenter, double-blind, randomized, placebo-controlled clinical trial in three parallel groups to evaluate efficacy and safety
| Arm | Type | Receives |
|---|---|---|
| Main (Mexidol) + Control (Placebo) | Other | Drug: Mexidol + PlaceboParticipants 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. |
| Main (Mexidol) | Active comparator | Drug: MexidolParticipants received Mexidol 125 mg 1 tablet orally twice a day for 42 days. |
| Control (Placebo) | Placebo comparator | Drug: PlaceboParticipants received Mexidol Placebo matching Mexidol 125 mg 1 tablet orally twice a day for 42 days. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- 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:
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mexidol125 mg tablets | Drug | Main (Mexidol) |
| PlaceboPlacebo tablets | Drug | Control (Placebo) |
| Mexidol + PlaceboCombination of Mexidol and Placebo | Drug | Main (Mexidol) + Control (Placebo) |
Primary outcome
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.
Time frame: Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day 1 = Randomization Visit)
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.
10 secondary outcomes
Average Change in the the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale "Inattention"
Time frame: 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"
Time frame: 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"
Time frame: 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"
Time frame: 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
Time frame: Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day 1 = Randomization Visit)
Average Change in the Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Score
Time frame: Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day 1 = Randomization Visit)
Assessment Using the Clinical Global Impressions for Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S) Scale
Time frame: Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day 1 = Randomization Visit)
Assessment Using the Clinical Global Impressions Scale for Improvement (CGI-I)
Time frame: Visit 5 (after 6 weeks of therapy) compared to the baseline level (before treatment)
Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Days
Time frame: Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day1 = Randomization Visit)
Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Headache Severity
Time frame: Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day1 = Randomization Visit)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Polina S. Nikiforova, MD principal investigator
State Autonomous Healthcare Institution of the Sverdlovsk Region "Multispecialty Clinical Medical Center 'Bonum'
Nikolay N. Zavadenko, Dr.Med.Sci, Prof. principal investigator
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
Olga V. Khaletskaya, Dr.Med.Sci, Prof. principal investigator
Limited Liability Company "NizhMedClinic"
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mexidol in people with Attention Deficit Hyperactivity Disorder (ADHD) and Anxiety Disorders and Symptoms, run by Pharmasoft at 14 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day 1 = Randomization Visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.