NCT05428033已完成3 期
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Determine the Efficacy and Safety of Once Daily Centanafadine Capsules for the Treatment of Children With Attention-deficit/Hyperactivity Disorder (ADHD)
Otsuka Pharmaceutical Development & Commercialization, Inc.1 个研究点 分布在 1 个国家目标入组 574 人开始时间: 2022年7月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 574
- 试验地点
- 1
- 主要终点
- Attention-Deficit/Hyperactivity Disorder Rating Scale Version 5 (ADHD-RS-5) Change from baseline in the ADHD-RS-5 symptoms total raw score (investigator interview with informant) at Week 6
研究概览
简要总结
This trial will be conducted to evaluate the efficacy of centanafadine once daily (QD) extended release (XR) versus placebo in the treatment of child subjects (4 to 12 years, inclusive) with ADHD. The trial will consist of a screening period, a double-blind treatment period, and follow-up period.
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
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 4 to 12 years (inclusive) at the time of informed consent/assent.
- •A primary diagnosis of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnosis criteria as confirmed with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
- •A minimum symptoms total raw score of ≥ 28 on the ADHD-RS-5 at baseline for all subjects.
- •A score of 4 or higher on the CGI-S-ADHD at baseline.
- •Subjects aged 4 or 5 years only: has failed adequate psychotherapy or in the investigator's opinion, is severe enough to require pharmacotherapy in the absence of prior psychotherapy.
排除标准
- •Comorbid diagnosis of: Tourette's Disorder, Generalized Anxiety Disorder that is severe enough to interfere with trial procedures, Panic Disorder, Conduct Disorder, Psychosis, Post-traumatic Stress Disorder, Bipolar Disorder, Autism Spectrum Disorder, Oppositional Defiant Disorder that is severe enough to interfere with trial conduct (allowed if it is not the primary focus of treatment), Obsessive-Compulsive Disorder that is severe enough to interfere with trial conduct (allowed if it is not the primary focus of treatment), or major depressive disorder (MDD) with current major depressive episode.
- •A significant risk of committing suicide based on history and the investigator's clinical judgment, or routine psychiatric status examination, Current suicidal behavior, Imminent risk of injury to self, Active suicidal ideation. A history of suicidal behavior (over the last 6 months).
- •Body mass index (BMI) ≥ 40 kg/m2 or ≤ 5th percentile for age and gender based on US Centers for Disease Control and Prevention (CDC) criteria.
- •Has initiated, changed, or discontinued receiving psychological interventions for ADHD within the 30 days before the screening visit, or is anticipated to start new treatment during the trial.
研究组 & 干预措施
Matching Placebo
Placebo Comparator
Cohort 1 and Cohort 2
Children (4 to 12 years of age, inclusive) to receive Placebo capsules will be matching in size and color.
干预措施: placebo capsule (Other)
Weight Based High Dose Centanafadine Capsules
Experimental
Cohort 1, (6 to 12 years of age)
Cohort 2, (4 to 5 years of age)
High dose - weight-based dosing
干预措施: centanafadine capsule (Drug)
Weight Based Low Dose Centanafadine Capsules
Experimental
Cohort 1, (6 to 12 years of age)
Low dose - weight-based dosing
干预措施: centanafadine capsule (Drug)
结局指标
主要结局
Attention-Deficit/Hyperactivity Disorder Rating Scale Version 5 (ADHD-RS-5) Change from baseline in the ADHD-RS-5 symptoms total raw score (investigator interview with informant) at Week 6
时间窗: From baseline to week 6
次要结局
- Conners-3 Parent Short- Change from baseline in Conners-3 Parent Short at Week 6(From baseline to week 6)
- Clinical Global Impression - Severity - Attention-Deficit/Hyperactivity Disorder (CGI-S-ADHD) change from baseline in CGI-S-ADHD at Week 6(From baseline to week 6)
研究者
研究点 (1)
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