NCT04895215已完成2 期
A Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety, and Tolerability of AB-2004 in an Autism Spectrum Disorder Population
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 23
- 主要终点
- The mean change in the ABC-I score (Irritability) from Baseline to Week 8 for AB-2004
研究概览
简要总结
The purpose of this study is to establish the potential benefits, safety, and tolerability of AB-2004 in participants with irritability associated with autism spectrum disorder.
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
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed, documented ASD (Diagnostic and Statistical Manual of Mental Disorders [DSM-5] criteria)
- •Aberrant Behavior Checklist - Irritability (ABC-I) score ≥18 at the Screening Period
- •Clinical Global Impression - Severity (CGI-S) scale score ≥4 at the Screening Period
排除标准
- •Use of an oral, injected, or inhaled antibiotic within 30 days prior to screening. Prophylactic oral antibiotic use of no more than 1 dose will be permitted
- •Current use of an oral controlled or extended-release medication
- •Have a comorbid major psychiatric condition (eg, schizophrenia or bipolar disorder) at screening that in the opinion of the Investigator may interfere with the subject's ability to complete study procedures/comply with study requirements
- •Current use of antipsychotics (eg, aripiprazole or risperidone)
研究组 & 干预措施
AB-2004
Experimental
干预措施: AB-2004 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The mean change in the ABC-I score (Irritability) from Baseline to Week 8 for AB-2004
时间窗: From baseline to Week 8 visit
次要结局
- Number of participants who reported treatment emergent adverse events (TEAEs)(From baseline to Week 8 visit)
- The mean change in the Clinical Global Impression-Severity (CGI-S) from Baseline to Week 8 for AB-2004 High Dose and AB-2004 Low Dose(From baseline to Week 8 visit)
研究者
研究点 (23)
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