NCT05279313已完成3 期
A Phase 3, Multicenter, Open-label, Long-term Trial Evaluating the Long-term Safety and Tolerability of Once Daily Centanafadine Capsules in Children and Adolescents (4 to 17 Years of Age, Inclusive) With Attention-deficit/Hyperactivity Disorder (ADHD).
Otsuka Pharmaceutical Development & Commercialization, Inc.169 个研究点 分布在 1 个国家目标入组 680 人开始时间: 2022年2月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 680
- 试验地点
- 169
- 主要终点
- Frequency and severity of treatment-emergent adverse events (TEAEs) will be assessed to determine long-term safety and tolerability of Centanafadine QD XR Capsules.
研究概览
简要总结
To evaluate long-term safety exposure
详细描述
This open-label study will assess the overall safety and tolerability of centanafadine once daily extended-release capsules in pediatric subjects (ages 4-17 years). The study will accept rollover subjects from double-blind parent trials and individuals that did not participate in one of the double-blind parent trials, may enroll as De Novo subjects after meeting all required study entry criteria. All subjects will complete a minimum of 52 weeks and may continue until all enrolled subjects within the age group the subject was in at the start of their participation in the trial (13 to 17 years; 6 to 12 years; 4 to 5 years) have had a chance to reach the Week 52 visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rollover subjects from double-blind parent trials inclusion criteria:
- •Subjects who completed the 6-week double-blind treatment period and the 7 (+2) day follow-up in a double-blind parent trial and who, in the opinion of the investigator, could potentially benefit from centanafadine QD XR for ADHD
- •De novo subjects inclusion criteria:
- •Males and females aged 4 to 17 years (inclusive) at the time of informed consent/assent.
- •A primary diagnosis of ADHD based on DSM-5 diagnosis criteria as confirmed with the MINI KID.
- •A minimum symptoms total raw score of ≥ 28 on the ADHD-RS-5 at baseline.
- •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.
- •Rollover subjects from double-blind parent trials
排除标准
- •Subjects who, during the double-blind parent trials, experienced, in the opinion of the investigator, poor tolerability to IMP or whose safety assessments resulted in new concerns that would suggest the subject may not be appropriate for a 52-week treatment with IMP.
- •De novo subjects exclusion criteria:
- •A 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, Binge Eating Disorder (adolescents only), Anorexia (adolescents only), Bulimia (adolescents only), 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), MDD with current major depressive episode, or has required treatment within the 3 months prior to screening, or in investigator's opinion, MDD may worsen or could be expected to require treatment during the course of this trial.
- •Subjects who are breast-feeding and/or have a positive pregnancy test result prior to receiving IMP.
- •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, history of suicidal behavior (over the last 6 months).
- •Body weight < 13 kg
- •BMI ≥ 40 kg/m2
- •Has initiated, changed, or discontinued receiving psychological interventions for ADHD within the 30 days before the screening visit, or are anticipated to start new treatment during the trial.
研究组 & 干预措施
Centanafadine Hydrochloride
Experimental
- Adolescents (13 to 17 years of age, inclusive) to receive 328.8 mg daily.
- Children (4 to 12 years of age, inclusive) will receive weight-based doses of centanafadine ranging from 82.2 mg to 328.8 mg daily
干预措施: Centanafadine Hydrochloride (Drug)
结局指标
主要结局
Frequency and severity of treatment-emergent adverse events (TEAEs) will be assessed to determine long-term safety and tolerability of Centanafadine QD XR Capsules.
时间窗: Minimum duration of 52 weeks, up to a maximum of approximately 136 weeks or early termination.
次要结局
未报告次要终点
研究者
研究点 (169)
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