NCT07086313招募中2 期
A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled, Japan-China Joint Trial to Evaluate the Efficacy and Safety of Two Dose Levels of EB-1020 QD XR Capsules Administered Orally Once Daily in Children and Adolescents With Attention-deficit/Hyperactivity Disorder
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 315
- 试验地点
- 1
- 主要终点
- Change from baseline in ADHD-RS-5 symptom total raw score at Week 6.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and examine the safety of two doses of EB-1020 QD XR capsule administered once daily orally in pediatric ADHD patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with a primary diagnosis of ADHD based on DSM-5 diagnostic criteria, differentiated from other mental disorders using the MINI-KID, excluding other specified ADHD or unspecified ADHD.
- •Participants with a symptom total raw score of>=28 (if not receiving any pharmacological treatment for ADHD) or>=22 (if receiving pharmacological treatment for ADHD) on the ADHD Rating Scale Version 5 (ADHD-RS-5) at screening.
- •Participants with a symptom total raw score of>=28 on the ADHD-RS-5 at baseline.
- •Participants with a score of 4 or higher on the Clinical Global Impression Severity - ADHD (CGI-S-ADHD) at baseline.
排除标准
- •Participants who have a positive pregnancy test result at baseline.
- •Participants determined to have the following diseases based on an interview using the MINI-KID.
- •Tourette's disorder
- •Panic disorder
- •Conduct disorder
- •Psychotic disorder
- •Post-traumatic stress disorder
- •Bipolar disorder
- •Participants with a generalized anxiety disorder requiring pharmacotherapy, based on the DSM-5 diagnostic criteria.
- •Participants with an autism spectrum disorder based on the DSM-5 diagnostic criteria.
- •Participants with a personality disorder, oppositional defiant disorder, or obsessive-compulsive disorder that is the primary focus of treatment, based on the DSM-5 diagnostic criteria.
- •Participants with a diagnosis of major depressive disorder (MDD), based on the DSM-5 diagnostic criteria who currently have a major depressive episode, or who have required treatment for MDD within the past 3 months prior to screening.
- •Also, participants who, in the judgment of the investigator or subinvestigator, may have a worsening of MDD during the trial or may require treatment during the trial period.
- •Participants who have a diagnosis of intellectual disability with an intelligence quotient (IQ) score less than
- •Participants who have a significant risk of committing suicide in the opinion of the investigator or subinvestigator, or based on the following evidence.
- •Active suicidal ideation as evidenced by an answer of "yes" on Questions 4 or 5 (over the last 6 months) on the section of suicidal ideation or a history of suicidal behavior (over the last 6 months) on the Baseline/Screening version of the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening.
- •Participants with a diagnosis of substance use disorder.
- •Platelets <= 130,000/mm3
- •Hemoglobin <= 11.2 g/dL
- •Neutrophils, absolute <= 1000/mm3
- •AST > 2 x ULN
- •ALT > 2 x ULN
- •eGFR < 45 mL/min/1.73 m2, calculated by the CKiD U25 equation
- •CPK >= 2 x ULN (except for the cases that the medical monitor determined that participant's inclusion is possible based on the discussion about the participant's condition with the investigator or subinvestigator)
- •Abnormal values for both free T4 and TSH
- •Participants who cannot agree to discontinuation of prohibited concomitant medication, such as ADHD medication or antidepressants.
研究组 & 干预措施
EB-1020(QD XR capsules) low dose
Experimental
干预措施: EB-1020 (Centanafadine) low dose (Drug)
EB-1020(QD XR capsules) high dose
Experimental
干预措施: EB-1020 (Centanafadine) high dose (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in ADHD-RS-5 symptom total raw score at Week 6.
时间窗: Baseline, Weeks 6
The ADHD-RS-5 is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (never to rarely/no problem) to 3 (very often/severe problem). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms). Negative change from Baseline indicates improvement. Mixed-effect model repeated measure (MMRM) was used for analysis.
次要结局
未报告次要终点
研究者
研究点 (1)
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