NCT05257265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 Adolescents With Attention-deficit/Hyperactivity Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.1 个研究点 分布在 1 个国家目标入组 459 人开始时间: 2022年2月2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
- 459
- 试验地点
- 1
- 主要终点
- Attention-Deficit/Hyperactivity Disorder Rating Scale Version 5 (ADHD-RS-5)
研究概览
简要总结
This trial will be conducted to evaluate the efficacy and safety of the Centanafadine extended release (XR) capsules in adolescent subjects (13 - 17 years, inclusive) with ADHD.
详细描述
The trial will consist of a screening period of up to 28 days (4 weeks), a 42-day (6-week) double-blind treatment period, and a 7 (+ 2)-day 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
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 13 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 for all subjects.
- •A score of 4 or higher on the CGI-S-ADHD at baseline.
排除标准
- •A comorbid diagnosis of: Tourette's Disorder, Generalized Anxiety Disorder severe enough to interfere with trial procedures, Panic Disorder, Conduct Disorder, Psychosis, Post-traumatic Stress Disorder, Bipolar Disorder, Autism Spectrum Disorder, Binge Eating Disorder, Anorexia, Bulimia, Oppositional Defiant Disorder severe enough to interfere with trial conduct (allowed if it is not the primary focus of treatment), Obsessive-Compulsive Disorder severe enough to interfere with trial conduct (allowed if it is not the primary focus of treatment), or MDD with current major depressive episode.
- •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).
- •BMI ≥ 40 kg/m2 or ≤ 5th percentile for age and gender based on US 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
Centanafadine 164.4 mg
Experimental
Participants received centanafadine hydrochloride 164.4 milligrams (mg) XR capsules, orally, QD up to 6 weeks.
干预措施: Centanafadine Hydrochloride (Drug)
Centanafadine 328.8 mg
Experimental
Participants received centanafadine hydrochloride 328.8 mg XR capsules, orally, QD up to 6 weeks.
干预措施: Centanafadine Hydrochloride (Drug)
Placebo
Placebo Comparator
Participants received centanafadine matching placebo capsules, orally, QD up to 6 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Attention-Deficit/Hyperactivity Disorder Rating Scale Version 5 (ADHD-RS-5)
时间窗: From baseline to week 6
Change from baseline in the ADHD-RS-5 symptoms total raw score (investigator interview with informant) at Week 6.
次要结局
- Clinical Global Impression - Severity - Attention-Deficit/Hyperactivity Disorder (CGI-S-ADHD)(From baseline to week 6)
- Conners-3 Parent Short- Change from baseline in Conners-3 Parent Short at Week 6(From baseline to week 6)
研究者
研究点 (1)
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