NCT01876719已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Forced Titration, Proof-of-Concept Study of AR08 in the Treatment of Attention Deficit Hyperactivity Disorder in Children (Ages 6 - 17)
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
- 122
- 试验地点
- 12
- 主要终点
- ADHD-RS-IV
研究概览
简要总结
This is a multicenter, multiple dose, randomized, double-blind, placebo-controlled, forced titration study. Patients will be randomized to 1 of 4 treatment groups in a 1:1:1:1 ratio. One-hundred twenty (120) patients are planned to be randomized. Each patient will receive AR08 (0.5, 1, or 2 mg per day) or matching placebo for seven (7) weeks.
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
- •Meets DSM-IV-TR criteria for a primary diagnosis of ADHD based on structured clinical interview, MINI-KID, as assessed by the Investigator
- •Minimum score of 28 on the ADHD-RS-IV at Baseline
- •Male or female ages 6 - 17 years, inclusive, at the time of Screening
- •Weighs ≥21 kg (46 pounds).
- •Is functioning at age appropriate levels intellectually, as deemed by the Investigator.
排除标准
- •Has a comorbid psychiatric diagnosis (comorbid psychiatric diagnosis will be established by the MINI-KID interview).
- •Has a positive response to either question 4 or 5 of the Baseline /Screening version of the pediatric Columbia Suicide Severity Rating Scale (C-SSRS)
- •History of daily usage (at least 28 days/month) of either anti-hypertensive or prophylactic anti-migraine medications prior to Screening
- •Current usage of medications known to cause QTc prolongation or ADHD medications.
研究组 & 干预措施
0.5 mg AR08
Experimental
0.5 mg AR08, QD for 7 weeks
干预措施: AR08 (Drug)
1.0 mg AR08
Experimental
1.0 mg AR08, QD for 7 weeks
干预措施: AR08 (Drug)
2.0 mg AR08
Experimental
2.0 mg AR08, QD for 7 weeks
干预措施: AR08 (Drug)
Placebo
Placebo Comparator
Placebo, QD for 7 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
ADHD-RS-IV
时间窗: Day 35
The primary endpoint is the ADHD-RS-IV; change from Baseline to Visit 7 (Day 35).
次要结局
- CGI-ADHD-S/I(Day 35)
- Conners' Parent Rating Scale(Day 49)
- Columbia Suicide Severity Rating Scale (C-SSRS)(Day 49)
研究者
研究点 (12)
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