A Phase 3 interventional study of Mexidol and Placebo in Attention Deficit Hyperactivity Disorder (ADHD) and Anxiety Disorders and Symptoms, sponsored by Pharmasoft. Completed at 14 sites in Russia. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-08-17.
Sponsored by Pharmasoft · Phase 3, Interventional, and Treatment
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.
1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.
This study's enrollment of 333 is above the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →Pharmasoft is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) established in accordance with ICD-10 and criteria by a psychiatrist or neurologist, specifically:
- According to DSM-5:
Symptoms are present in at least two areas of functioning (in preschool or school and at home).
- And/or according to ICD-10:
Exclusion Criteria:
Individuals who exhibit at least one of the following characteristics were not included in the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Participants received Mexidol 125 mg 1 tablet orally twice a day for 42 days.
Drug: Mexidol
Participants received Mexidol Placebo matching Mexidol 125 mg 1 tablet orally twice a day for 42 days.
Drug: Placebo
125 mg tablets
Placebo tablets
Combination of Mexidol and Placebo
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.
Time frame: Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day 1 = Randomization Visit)
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.
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"
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.
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"
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.
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"
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.
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
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.
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
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.
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
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.
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)
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.
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
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.
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
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.
Time frame: Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day1 = Randomization Visit)
Participants were recruited based on protocol requirements at 14 clinical sites between July 2019 and May 2020. The first participant was enrolled on 13 July, 2019 and the last participant was enrolled on 22 May, 2020.
| Milestone | Main (Mexidol) + Control (Placebo) | Main (Mexidol) | Control (Placebo) |
|---|---|---|---|
| Started | 111 | 111 | 111 |
| Completed | 111 | 111 | 110 |
| Not completed | 0 | 0 | 1 |
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.
| score on a scale | Main (Mexidol) + Control (Placebo) | Main (Mexidol) | Control (Placebo) |
|---|---|---|---|
| SNAP-IV at Visit 5 | 25.41 (23.91 to 26.92) | 23.04 (21.49 to 24.58) | 29.10 (27.66 to 30.54) |
| Difference at Visit 5 compared to Visit 2 | -7.31 (-8.44 to -6.17) | -9.33 (-10.59 to -8.07) | -3.93 (-5.11 to -2.75) |
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.
| score on a scale | Main (Mexidol) + Control (Placebo) | Main (Mexidol) | Control (Placebo) |
|---|---|---|---|
| SNAP-IV, Subscale "Inattention" at Visit 5 | 14.04 ± 3.79 | 12.84 ± 4.50 | 15.95 ± 3.85 |
| Difference at Visit 5 compared to Visit 1 | -3.80 ± 3.62 | -4.54 ± 3.87 | -2.05 ± 3.55 |
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.
| score on a scale | Main (Mexidol) + Control (Placebo) | Main (Mexidol) | Control (Placebo) |
|---|---|---|---|
| SNAP-IV, Subscale "Hyperactivity/Impulsivity" at Visit 5 | 11.38 ± 5.06 | 10.20 ± 4.58 | 13.15 ± 4.76 |
| Difference at Visit 5 compared to Visit 1 | -3.50 ± 3.36 | -4.79 ± 3.64 | -1.87 ± 3.28 |
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.
| score on a scale | Main (Mexidol) + Control (Placebo) | Main (Mexidol) | Control (Placebo) |
|---|---|---|---|
| SNAP-IV, Subscale "Oppositional Defiant Disorder" at Visit 5 | 4.06 ± 4.91 | 3.69 ± 4.88 | 4.43 ± 4.48 |
| Difference at Visit 5 compared to Visit 1 | -1.10 ± 2.50 | -0.95 ± 2.57 | -0.81 ± 2.78 |
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.
| score on a scale | Main (Mexidol) + Control (Placebo) | Main (Mexidol) | Control (Placebo) |
|---|---|---|---|
| SNAP-IV), Subscale "Connors Index" at Visit 5 | 8.71 ± 4.83 | 8.21 ± 5.39 | 10.33 ± 4.57 |
| Difference at Visit 5 compared to Visit 1 | -3.32 ± 2.99 | -3.18 ± 3.17 | -2.00 ± 3.37 |
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.
| score on a scale | Main (Mexidol) + Control (Placebo) | Main (Mexidol) | Control (Placebo) |
|---|---|---|---|
| SCAS-Parent at Visit 5 | 10.23 ± 13.66 | 10.41 ± 15.33 | 10.22 ± 10.64 |
| Difference at Visit 5 compared to Visit 2 | -2.90 ± 5.45 | -2.86 ± 6.27 | -3.05 ± 6.76 |
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.
| score on a scale | Main (Mexidol) + Control (Placebo) | Main (Mexidol) | Control (Placebo) |
|---|---|---|---|
| ADHD-RS-IV at Visit 5 | 25.23 ± 8.01 | 23.14 ± 8.26 | 28.85 ± 7.68 |
| Difference at Visit 5 compared to Visit 2 | -7.32 ± 6.15 | -9.54 ± 6.88 | -3.92 ± 6.16 |
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.
| Participants | Main (Mexidol) + Control (Placebo) | Main (Mexidol) | Control (Placebo) |
|---|---|---|---|
| Level 2 (borderline mentally ill) | 8 | 8 | 2 |
| Level 3 (mildly ill) | 26 | 58 | 23 |
| Level 4 (moderately ill) | 77 | 44 | 86 |
| Level 5 (markedly ill) | 0 | 1 | 0 |
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.
| Participants | Main (Mexidol) + Control (Placebo) | Main (Mexidol) | Control (Placebo) |
|---|---|---|---|
| 1, very much improved | 3 | 13 | 2 |
| 2, much improved | 20 | 45 | 10 |
| 3, minimally improved | 61 | 37 | 38 |
| 4, no change | 27 | 14 | 58 |
| 5, minimally worse | 0 | 1 | 3 |
| 6, much worse | 0 | 1 | 0 |
| 7, very much worse | 0 | 0 | 0 |
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.
| days | Main (Mexidol) + Control (Placebo) | Main (Mexidol) | Control (Placebo) |
|---|---|---|---|
| Number of days with limited daily activities | 4.25 ± 10.97 | 0.22 ± 0.38 | 2.38 ± 2.03 |
| No of days with limited activity: Visit 5 compared to Visit 2 | -6.71 ± 11.77 | -0.33 ± 0.33 | 0.76 ± 1.46 |
| Number of days with a headache | 9.58 ± 10.73 | 5.11 ± 2.52 | 4.95 ± 2.52 |
| No of days with headache: Visit 5 compared to Visit 2 | 0.54 ± 8.45 | 1.89 ± 4.72 | 0.10 ± 3.72 |
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.
| score on a scale | Main (Mexidol) + Control (Placebo) | Main (Mexidol) | Control (Placebo) |
|---|---|---|---|
| Moderate headache severity | 3.88 ± 2.10 | 3.00 ± 1.00 | 3.71 ± 1.25 |
| Moderate headache: Visit 5 compared to Visit 2 | -0.38 ± 1.19 | 0.00 ± 0.00 | -0.14 ± 0.90 |
| Maximal headache severity | 6.13 ± 3.00 | 5.33 ± 2.31 | 5.57 ± 1.51 |
| Max headache: Visit 5 compared to Visit 2 | 0.38 ± 1.85 | 1.33 ± 2.31 | -0.57 ± 1.72 |
Collected over From Day 1 (Visit 2) to Day 50+3 (Visit 6) or Early Termination Visit. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Main (Mexidol) + Control (Placebo) | 0/111 (0%) | 0/111 (0%) | 14/111 (12.6%) |
| Main (Mexidol) | 0/111 (0%) | 1/111 (0.9%) | 26/111 (23.4%) |
| Control (Placebo) | 0/111 (0%) | 1/111 (0.9%) | 20/111 (18%) |
| Event | Main (Mexidol) + Control (Placebo) | Main (Mexidol) | Control (Placebo) |
|---|---|---|---|
| Respiratory tract infectionInfections and infestations | 0/111 | 0/111 | 1/111 |
| FuruncleInfections and infestations | 0/111 | 1/111 | 0/111 |
| Event | Main (Mexidol) + Control (Placebo) | Main (Mexidol) | Control (Placebo) |
|---|---|---|---|
| Respiratory tract infectionInfections and infestations | 2/111 | 2/111 | 4/111 |
| RhinitisInfections and infestations | 1/111 | 4/111 | 3/111 |
| HeadacheNervous system disorders | 2/111 | 3/111 | 2/111 |
| Abdominal pain upperGastrointestinal disorders | 1/111 | 2/111 | 0/111 |
| NauseaGastrointestinal disorders | 2/111 | 2/111 | 2/111 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 0/111 | 2/111 | 0/111 |
| Irritable bowel syndromeGastrointestinal disorders | 0/111 | 0/111 | 1/111 |
| NasopharyngitisInfections and infestations | 1/111 | 1/111 | 1/111 |
| Herpes zosterInfections and infestations | 1/111 | 0/111 | 0/111 |
| OtosalpingitisInfections and infestations | 0/111 | 0/111 | 1/111 |
| Age, Categorical(Participants) | Main (Mexidol) + Control (Placebo) | Main (Mexidol) | Control (Placebo) | Total |
|---|---|---|---|---|
| <=18 years | 111 | 111 | 111 | 333 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(Years) | Main (Mexidol) + Control (Placebo) | Main (Mexidol) | Control (Placebo) | Total |
|---|---|---|---|---|
| Median | 8 (7 to 10) | 9 (7 to 10) | 8 (7 to 10) | 8 (7 to 10) |
| Sex: Female, Male(Participants) | Main (Mexidol) + Control (Placebo) | Main (Mexidol) | Control (Placebo) | Total |
|---|---|---|---|---|
| Female | 37 | 29 | 31 | 97 |
| Male | 74 | 82 | 80 | 236 |
| Race and Ethnicity Not Collected(Participants) | Main (Mexidol) + Control (Placebo) | Main (Mexidol) | Control (Placebo) | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Region of Enrollment(Participants) | Main (Mexidol) + Control (Placebo) | Main (Mexidol) | Control (Placebo) | Total |
|---|---|---|---|---|
| Russia | 111 | 111 | 111 | 333 |
| SNAP-IV, Subscales "Inattention" and "Hyperactivity/Impulsivity" at Visit 2 (Randomization Visit)(score on a scale) | Main (Mexidol) + Control (Placebo) | Main (Mexidol) | Control (Placebo) | Total |
|---|---|---|---|---|
| Mean | 32.72 ± 6.73 | 32.37 ± 6.91 | 33.03 ± 7.18 | 32.70 ± 6.93 |
| SNAP-IV, Subscale "Inattention" at Visit 1 (Screening)(score on a scale) | Main (Mexidol) + Control (Placebo) | Main (Mexidol) | Control (Placebo) | Total |
|---|---|---|---|---|
| Mean | 17.84 ± 3.52 | 17.38 ± 3.79 | 18.00 ± 3.76 | 17.74 ± 3.69 |
| SNAP-IV, Subscale "Hyperactivity/Impulsivity at Visit 1 (Screening)(score on a scale) | Main (Mexidol) + Control (Placebo) | Main (Mexidol) | Control (Placebo) | Total |
|---|---|---|---|---|
| Mean | 14.88 ± 4.27 | 14.99 ± 4.22 | 15.03 ± 4.51 | 14.96 ± 4.32 |
7 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2019 to primary completion in Jul 2020, 12 months.
Results were first posted in Aug 2025, 5 years 1 month after primary completion.
Of 66 industry-sponsored phase 3 interventional studies under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 19. This study's 12 months is close to that.
Counting every sponsor, half of 80 studies reached it within 14 months; a quarter within 7 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Emoxypine succinate
Attention Deficit Disorder with Hyperactivity →
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