Mexidol
Drug125 mg tablets
NCT Number: NCT06854601
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.
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Notify Me6 year–12 year
All sexes
Interventional
Phase 3
State Autonomous Healthcare Institution of the Sverdlovsk Region "Multispecialty Clinical Medical Center 'Bonum', Yekaterinburg, Ural Region, Russia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Individuals who exhibit at least one of the following characteristics were not included in the study:
125 mg tablets
Placebo tablets
Combination of Mexidol and Placebo
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.
Time frame: Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 1 Day 0 = Screening)
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)
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)
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)
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 2 Day 1 = Randomization Visit)
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)
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)
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 (before treatment)
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 (Visit 2 Day1 = Randomization Visit)
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)
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.
Pharmasoft
Industry
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).
Acronym: MEGA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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