NCT06931080招募中2 期
A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled, Trial to Evaluate the Efficacy and Safety of EB-1020 Once Daily QD XR Capsules Administered Orally at Low or High Dose in Adults With Attention-deficit/Hyperactivity Disorder
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 630
- 试验地点
- 1
- 主要终点
- Change from baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) score at Week6
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 adult 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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants diagnosed primarily with ADHD (excluding other specified or unspecified attention-deficit/hyperactivity disorder) according to DSM-5 criteria, based on information collected through interviews using the Japanese version of the Conners' Adult ADHD Diagnostic Interview for DSM-IVTM (CAADID).
- •Participants with an AISRS total score meeting the following criteria:
- •Not receiving medication treatment for ADHD: 28 points or higher
- •Receiving medication treatment for ADHD: 22 points or higher
排除标准
- •Participants who are pregnant or breastfeeding, and those who test positive for pregnancy at screening.
- •Participants have a current comorbid psychiatric disorder that either could be expected to require treatment with medications prohibited in this trial, or to confound efficacy or safety assessments. Examples include, but are not limited to, psychotic disorder (current or lifetime), bipolar disorder (current or lifetime), generalized anxiety disorder, obsessive-compulsive disorder, panic disorder, a current major depressive episode, or posttraumatic stress disorder, as established by the MINI.
- •Participants diagnosed with a personality disorder according to DSM-5 criteria.
- •Participants diagnosed with autism spectrum disorder according to DSM-5 criteria.
- •Participants diagnosed with intellectual disability and an IQ score below
- •Participants who, in the judgment of the principal or sub-investigator, or based on the following criteria, are at significant risk of suicide:
- •Clear suicidal ideation or a history of suicidal behavior (within the past 6 months) as indicated by a ""yes"" answer to questions 4 or 5 in the suicidal ideation section of the C-SSRS Baseline/Screening version at screening.
- •Participants who have a current or past episode of substance-related disorders (excluding tobacco-related disorders) according to DSM-5 diagnostic criteria.
- •Participants diagnosed with eating disorders and feeding disorders according to DSM-5 diagnostic criteria.
- •Participants who show a positive reaction in alcohol tests or urine drug tests at screening.
- •Participants with complications or a history of the following neurological disorders:
- •Seizures (other than infantile febrile seizures)
- •Tourette's disorder
- •History of significant head trauma with clinically significant loss of consciousness
- •Cerebrovascular disease
- •Parkinson's disease
- •Intracranial lesions
- •Other severe neurological disorders
- •Participants with complications or a history of cardiovascular diseases.
- •Participants with clinical laboratory test results at screening that meet any of the following criteria:
- •Platelets <= 75,000/mm3
- •Hemoglobin <= 9 g/dL
- •Neutrophils, absolute <= 1000/mm3
- •AST > 2 x ULN
- •ALT > 2 x ULN
- •Creatinine >= 2 mg/dL
- •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) 164.4 mg
Experimental
干预措施: EB-1020 (Centanafadine) 164.4 mg (Drug)
EB-1020(QD XR capsules) 328.8 mg
Experimental
干预措施: EB-1020 (Centanafadine) 328.8 mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) score at Week6
时间窗: Baseline, Weeks 6
The Adult Investigator Symptom Rating Scale (AISRS) is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (none) to 3 (severe). 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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