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).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pharmasoft
- 入组人数
- 333
- 试验地点
- 14
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Individuals who exhibit at least one of the following characteristics were not included in the study:
- •Increased sensitivity to the active substance of the investigational drug (ethylmethylhydroxypyridine succinate) and/or other components of the drug.
- •Liver dysfunction: ALT and/or AST ≥2.5 times the upper limit of normal (ULN) based on screening lab results.
- •Kidney dysfunction: serum creatinine ≥1.5 times ULN based on screening lab results.
- •Intracranial pathology (including but not limited to: intracranial hemorrhage, tumors, infections, history of head trauma, excluding concussion).
- •Co-occurring autism spectrum disorders, Asperger syndrome.
- •Intellectual disability of any degree.
- •Other mental disorders, except for behavioral disorders (ICD-10 code F91).
- •Inability to discontinue psychotropic medications used for the treatment of ADHD.
- •Other somatic and/or neurological disorders requiring treatment with medications that may affect the efficacy of the investigational drug (including but not limited to: epilepsy, depression).
- •Use of nootropic, vasoactive medications, neuroprotectors, antioxidants, or metabolic agents within 7 days or 5 half-lives (whichever is longer) prior to randomization.
- •Presence of any oncological disease in the medical history within 5 years prior to the screening visit.
- •Participation in any other clinical study of drugs and/or medical devices within 3 months prior to the screening visit and/or 5 half-lives, whichever is longer.
- •Inability or unwillingness to comply with protocol requirements, including for physical, mental, or social reasons, in the opinion of the investigator.
- •Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
研究组 & 干预措施
Control (Placebo)
Participants received Mexidol Placebo matching Mexidol 125 mg 1 tablet orally twice a day for 42 days.
干预措施: Placebo (Drug)
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.
干预措施: Mexidol + Placebo (Drug)
Main (Mexidol)
Participants received Mexidol 125 mg 1 tablet orally twice a day for 42 days.
干预措施: Mexidol (Drug)
结局指标
主要结局
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.
时间窗: 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.
次要结局
- Average Change in the the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale "Inattention"(Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 1 Day 0 = Screening))
- Average Change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale "Oppositional Defiant Disorder"(Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 1 Day 0 = Screening))
- Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Days(Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day1 = Randomization Visit))
- Average Change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale "Hyperactivity/Impulsivity"(Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 1 Day 0 = Screening))
- Assessment Using the Clinical Global Impressions Scale for Improvement (CGI-I)(Visit 5 (after 6 weeks of therapy) compared to the baseline level (before treatment))
- Average Change in the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), Subscale "Connors Index"(Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 1 Day 0 = Screening))
- Average Change in the Spence Children's Anxiety Scale - Parent Version (SCAS-Parent) Score(Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day 1 = Randomization Visit))
- Average Change in the Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Score(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(Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day 1 = Randomization Visit))
- Assessment Using the Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS), Headache Severity(Visit 5 (after 6 weeks of therapy) compared to the baseline level (Visit 2 Day1 = Randomization Visit))