NCT01364662已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPN-810 as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD)
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
- 121
- 主要终点
- Reduction in aggressive behavior as assessed by R-MOAS score
研究概览
简要总结
This will be a randomized, double-blind, placebo-controlled, dose-ranging, efficacy and safety study in children with impulsive aggression comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD). The target subjects are healthy male and female children aged 6 to 12 years, inclusive, with a diagnosis of ADHD. A total of 120 subjects will be randomized across approximately 30 US centers to one of four treatment groups.
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 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy pediatric male or female subjects, age 6 to 12 years.
- •Diagnostic and Statistical Manual of Mental Disorders - IV -Text Revision (DSM-IV-TR) diagnosis of ADHD.
- •R-MOAS score >=24 at screening and R-MOAS score >=20 for randomization
- •IQ greater than
- •Weight of >=20kg
- •current treatment with psychostimulant (1 month prior to screening)
排除标准
- 未提供
研究组 & 干预措施
2
Experimental
干预措施: SPN-810 (Drug)
1
Experimental
干预措施: Placebo (Drug)
3
Experimental
干预措施: SPN-810 (Drug)
4
Experimental
干预措施: SPN-810 (Drug)
结局指标
主要结局
Reduction in aggressive behavior as assessed by R-MOAS score
时间窗: Change from baseline to Visit 10
次要结局
- Safety of SPN-810 Safety as assessed by safety scales, AEs, clinical labs, vitals, Physical Exams, and ECGs(Visit 2 to End of Study)
- Change in CGI-S(Baseline to Visit 5)
- CGI-I score at each post-baseline Visit(Baseline to Visit 5)
- Change in SNAP-IV ADHD scores(Baseline to Visit 5)
研究者
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