NCT07755410招募中2 期
A Phase 2, Randomized, Parallel-Group, Double-Blind, Study to Evaluate the Safety and Efficacy of ALKS 7290 Compared to Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder
适应症
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
- 312
- 试验地点
- 2
- 主要终点
- Change from Baseline to Week 4 in Attention Deficit Disorder Investigator Symptom Rating Scale (AISRS) total score
研究概览
简要总结
The purpose of this study is to measure safety and the improvement in symptoms in subjects with ADHD when taking ALKS 7290 tablets compared with placebo tablets.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the Diagnostic and Statistical Manual of Mental Disorders -5 criteria for ADHD, as confirmed by the Mini-International Neuropsychiatric Interview (MINI) for ADHD Studies 7.0.
- •Is otherwise healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring. Participants must be stable on permitted medication for 2 months prior to first visit, without anticipated changes to dose.
- •AISRS total score of ≥26
- •CGI-S score ≥ 4 (moderately ill or worse)
- •Has a Body Mass Index within 18 to 35 kg/m2
排除标准
- •Has a known history of intellectual developmental disorder or cognitive impairment that, in the opinion of the Investigator, would interfere with study participation.
- •Has any of the following psychiatric conditions per the DSM-5 criteria, as assessed by the MINI. Conditions not assessable by the MINI should be assessed by clinical judgement; Diagnosis of schizophrenia, schizoaffective disorder, or bipolar I or II disorder, or current, unstable, MDD or GAD.
- •Clinically significant cognitive difficulties including dementia, delirium or amnestic syndromes, or any other cognitive disorder present with the past 2 years that could interfere with participation in the study.
- •Moderate to severe substance use disorder according to DSM-5 guidelines, including use of alcohol, nicotine, cannabis, narcotics, or any illicit substance.
- •Any other psychiatric condition that could interfere with participation in the study.
研究组 & 干预措施
Dose Level 3
Experimental
干预措施: ALKS 7290 (Drug)
Placebo
Placebo Comparator
Placebo capsule taken daily
干预措施: Placebo (Drug)
Dose Level 1
Experimental
干预措施: ALKS 7290 (Drug)
Dose Level 2
Experimental
干预措施: ALKS 7290 (Drug)
结局指标
主要结局
Change from Baseline to Week 4 in Attention Deficit Disorder Investigator Symptom Rating Scale (AISRS) total score
时间窗: Baseline to Week 4
次要结局
- Change from Baseline to Week 4 in Clinical Global Impression- Severity (CGI-S) scale score(Baseline to Week 4)
- Incidence of treatment-emergent adverse events(Up to 6 weeks)
研究者
研究点 (2)
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