TRI102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHA): A Laboratory Classroom Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 5
- 主要终点
- SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale)
研究概览
简要总结
The purpose of this study is to determine whether TRI102 is effective in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children ages 6-12.
详细描述
A Phase 3, randomized, double-blind, placebo-controlled, parallel group, multicenter, laboratory classroom study. After Screening and Baseline evaluations, eligible subjects are enrolled in the study and entered the open-label phase, dose-optimization phase. TRI102 is taken once daily and subjects undergo dose optimization activities for 5 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 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6 to 12 years with ADHD who require pharmacologic treatment for this condition
排除标准
- •Other serious illnesses or conditions that would put the patient at particular risk for safety events or would interfere with treatment/assessment of ADHD
研究组 & 干预措施
TRI102
Active, amphetamine extended-release oral suspension
干预措施: TRI102 (Drug)
Placebo
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale)
时间窗: Absolute change from baseline in SKAMP-C score from baseline to 4 hours after dose
Change from baseline in SKAMP-Combined Scores measured approximately 4 hours after dose (active or placebo). The SKAMP-Combined score is obtained by summing 13 assessment items, where each item is rated on a 7-point scale (0 = normal to 6 = maximal impairment). This gives an overall (combined) SKAMP Score of 0= normal to 78 which indicates maximal impairment. The endpoint is assessed as a change from baseline in the overall score on the 78-point scale.
次要结局
- PERMP (Permanent Product Measure of Performance).(Absolute change from baseline in PERMP questions answered correctly, measured from baseline to 4 hours postdose.)