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| ID | Type | Description | Link |
|---|---|---|---|
| PHS-ADHD-002-MEX-TAB | Other Identifier | Pharmasoft |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Main (Mexidol) | Active Comparator | Participants received Mexidol 125 mg 1 tablet orally twice a day for 42 days. |
|
| Control (Placebo) | Placebo Comparator | Participants received Mexidol Placebo matching Mexidol 125 mg 1 tablet orally twice a day for 42 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mexidol | Drug | 125 mg tablets |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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.
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:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Autonomous Healthcare Institution of the Sverdlovsk Region "Multispecialty Clinical Medical Center 'Bonum' | Yekaterinburg | Ural Region | 620075 | Russia |
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Of 340 screened participants, 333 met inclusion criteria and were randomized to treatment.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Main (Mexidol) + Control (Placebo) | 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. |
| FG001 | Main (Mexidol) | Participants received Mexidol 125 mg 1 tablet orally twice a day for 42 days. |
| FG002 | Control (Placebo) | Participants received Mexidol Placebo matching Mexidol 125 mg 1 tablet orally twice a day for 42 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Main (Mexidol) + Control (Placebo) | 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. |
| BG001 | Main (Mexidol) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day 1 = Randomization Visit) |
From Day 1 (Visit 2) to Day 50+3 (Visit 6) or Early Termination Visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Main (Mexidol) + Control (Placebo) | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory tract infection | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Y.E. Meshcherskiy, Medical Director | Pharmasoft | + 7 (495) 626-47- 55 | 140 | meshcherskiy_y@pharmasoft.ru |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 15, 2019 | May 16, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 27, 2019 | Apr 4, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D001008 | Anxiety Disorders |
| D013035 | Spasm |
| D000096865 | Oppositional Defiant Disorder |
| D065886 | Neurodevelopmental Disorders |
| D007175 | Impulsive Behavior |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D001523 | Mental Disorders |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| C070020 | emoxypine succinate |
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Multicenter, double-blind, randomized, placebo-controlled clinical trial in three parallel groups to evaluate efficacy and safety
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| Drug |
Placebo tablets |
|
| Mexidol + Placebo | Drug | Combination of Mexidol and Placebo |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day1 = Randomization Visit) |
| 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 |
| Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" Ministry of Health of the Russian Federation | Kazan' | 420012 | Russia |
| State Budgetary Healthcare Institution "Specialized Clinical Psychiatric Hospital №1" of the Ministry of Health of the Krasnodar Territory | Krasnodar | 350007 | Russia |
| Limited Liability Company "Center for Professional Therapy" | Krasnodar | 350051 | Russia |
| 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 |
| 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 |
| Limited Liability Company "NizhMedClinic" | Nizhny Novgorod | 603006 | Russia |
| State Budgetary Healthcare Institution "Orenburg Regional Clinical Psychiatric Hospital №1" | Orenburg | 460015 | Russia |
| Limited Liability Company "Medical Technologies" | Saint Petersburg | 192148 | Russia |
| Limited Liability Company "DNA Research Center" | Saratov | 410005 | Russia |
| Federal State Budgetary Educational Institution of Higher Education "Tver State Medical University" Ministry of Health of the Russian Federation | Tver' | 170100 | Russia |
| Federal State Budgetary Educational Institution of Higher Education "Tyumen State Medical University" Ministry of Health of the Russian Federation | Tyumen | 625000 | Russia |
| State Healthcare Institution "Central Clinical Medical-Sanitary Unit named after Honored Doctor of Russia V.A. Egorov" | Ulyanovsk | 432026 | Russia |
| Limited Liability Company "European Medical Center 'UGMK-Health'" | Yekaterinburg | 620144 | Russia |
Participants received Mexidol 125 mg 1 tablet orally twice a day for 42 days.
| BG002 | Control (Placebo) | Participants received Mexidol Placebo matching Mexidol 125 mg 1 tablet orally twice a day for 42 days. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| SNAP-IV, Subscales "Inattention" and "Hyperactivity/Impulsivity" at Visit 2 (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. Higher score indicates higher symptom severity. | Mean | Standard Deviation | score on a scale |
|
| SNAP-IV, Subscale "Inattention" at Visit 1 (Screening) | The Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV) is a 90-question self-report inventory designed to measure different domains of ADHD and ODD. 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. 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. Higher score indicates higher symptom severity. | Mean | Standard Deviation | score on a scale |
|
| SNAP-IV, Subscale "Hyperactivity/Impulsivity at Visit 1 (Screening) | The Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV) is a 90-question self-report inventory designed to measure different domains of ADHD and ODD. 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. 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. Higher score indicates higher symptom severity. | Mean | Standard Deviation | score on a scale |
|
| SNAP-IV, Subscale "Oppositional Defiant Disorder" at Visit 1 (Screening) | The Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV) is a 90-question self-report inventory designed to measure different domains of ADHD and ODD. 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. 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. Higher score indicates higher symptom severity. | Mean | Standard Deviation | score on a scale |
|
| SNAP-IV, Subscale "Connors Index" at Visit 1 (Screening) | The Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV) is a 90-question self-report inventory designed to measure different domains of ADHD and ODD. 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. 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. Higher score indicates higher symptom severity. | Mean | Standard Deviation | score on a scale |
|
| SCAS-Parent at Visit 2 (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. It evaluates six distinct domains of anxiety that align with clinical diagnostic categories. Each question 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. | Mean | Standard Deviation | score on a scale |
|
| ADHD-RS-IV at Visit 2 (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. | Mean | Standard Deviation | score on a scale |
|
| CGI-ADHD-S Scale before treatment | 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: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. | Count of Participants | Participants |
|
| PedMIDAS at Visit 2 (Randomization Visit) | The Pediatric Migraine DisabilityAssessment (PedMIDAS) questionnaire is used toassess the impact of headaches on schoolperformance (three questions), activities at home (onequestion on homework or chores), and social and/orsports functions (two questions). It is scored bysumming the answers across the six questions.PedMIDAS score range from 0 to 10 indicates little tonone disability grade, score range from 11 to 30indicates mild disability grade, score range from 31 to50 indicates moderate disability grade and score rangegreater than 50 indicates severe disability grade. | The scoreson this questionnaire were evaluated only for patientswho were found to have a headache. Thus, the data forcomparing the results at the end of the therapy with theresults at the beginning of the therapy were availablefor 18 patients. | Mean | Standard Deviation | days |
|
| PedMIDAS at Visit 2 (Randomization Visit) | The Pediatric Migraine DisabilityAssessment (PedMIDAS) questionnaire is used toassess the impact of headaches on schoolperformance (three questions), activities at home (onequestion on homework or chores), and social and/orsports functions (two questions). It is scored bysumming the answers across the six questions.PedMIDAS score range from 0 to 10 indicates little tonone disability grade, score range from 11 to 30indicates mild disability grade, score range from 31 to50 indicates moderate disability grade and score rangegreater than 50 indicates severe disability grade. | The scoreson this questionnaire were evaluated only for patientswho were found to have a headache. Thus, the data forcomparing the results at the end of the therapy with theresults at the beginning of the therapy were availablefor 18 patients. | Mean | Standard Deviation | scores on ascale |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Main (Mexidol) + Control (Placebo) | 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. |
| OG001 | Main (Mexidol) | Participants received Mexidol 125 mg 1 tablet orally twice a day for 42 days. |
| OG002 | Control (Placebo) | Participants received Mexidol Placebo matching Mexidol 125 mg 1 tablet orally twice a day for 42 days. |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 1 Day 0 = Screening) |
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 1 Day 0 = Screening) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 1 Day 0 = Screening) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 1 Day 0 = Screening) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day 1 = Randomization Visit) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day 1 = Randomization Visit) |
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| Secondary | 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. | Posted | Count of Participants | Participants | Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day 1 = Randomization Visit) |
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| Secondary | 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. | Posted | Count of Participants | Participants | Visit 5 (after 6 weeks of therapy) compared to the baseline level (before treatment) |
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| Secondary | 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. | The scores on this questionnaire were evaluated only for patients who were found tohave a headache. Thus, the data for comparing the results at the end of the therapy withthe results at the beginning of the therapy were available for 18 patients. | Posted | Mean | Standard Deviation | days | Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day1 = Randomization Visit) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day1 = Randomization Visit) |
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| 0 |
| 111 |
| 0 |
| 111 |
| 14 |
| 111 |
| EG001 | Main (Mexidol) | Participants received Mexidol 125 mg 1 tablet orally twice a day for 42 days. | 0 | 111 | 1 | 111 | 26 | 111 |
| EG002 | Control (Placebo) | Participants received Mexidol Placebo matching Mexidol 125 mg 1 tablet orally twice a day for 42 days. | 0 | 111 | 1 | 111 | 20 | 111 |
| Furuncle | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
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| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 23.1 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
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| Otosalpingitis | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
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| Furuncle | Infections and infestations | MedDRA version 23.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 23.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 23.1 | Systematic Assessment |
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| Oral allergy syndrome | Immune system disorders | MedDRA version 23.1 | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA version 23.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
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| Disturbance in attention | Nervous system disorders | MedDRA version 23.1 | Systematic Assessment |
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| Meibomianitis | Eye disorders | MedDRA version 23.1 | Systematic Assessment |
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| Urine abnormality | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
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| Leukocyturia | Renal and urinary disorders | MedDRA version 23.1 | Systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA version 23.1 | Systematic Assessment |
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| Affect lability | Psychiatric disorders | MedDRA version 23.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA version 23.1 | Systematic Assessment |
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| Listless | Psychiatric disorders | MedDRA version 23.1 | Systematic Assessment |
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| Inappropriate affect | Psychiatric disorders | MedDRA version 23.1 | Systematic Assessment |
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| Animal bite | Injury, poisoning and procedural complications | MedDRA version 23.1 | Systematic Assessment |
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Not provided
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Level 4 (moderately ill) |
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| Level 5 (markedly ill) |
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| Title | Measurements |
|---|---|
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| 3, minimally improved |
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| 4, no change |
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| 5, minimally worse |
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| 6, much worse |
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| 7, very much worse |
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| Number of days with a headache |
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| No of days with headache: Visit 5 compared to Visit 2 |
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| Maximal headache severity |
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| Max headache: Visit 5 compared to Visit 2 |
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