NCT03618030已完成3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Adult Laboratory Classroom Study to Evaluate the Safety and Efficacy of PRC-063 Compared to Placebo in Adults With ADHD
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 6
- 主要终点
- Post-dose PERMP-T (Permanent Measure of Productivity - Total Score) Scores Measured During the Full-day Adult Laboratory Classroom Visit
研究概览
简要总结
This is a randomized, double-blind, parallel group, placebo-controlled, dose optimized, phase 3 study to evaluate the safety and efficacy of PRC-063 in the treatment of ADHD in adults
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females 18 to 60 years of age
- •Diagnosis of ADHD (any type: combined, predominately hyperactive impulsive type or predominately inattentive type) by a psychiatrist, psychologist, or licensed allied healthcare professional
- •Subject is willing and able to comply with all the protocol requirements.
排除标准
- •Primary and/or comorbid psychiatric diagnosis other than ADHD
- •Has a current or recent history of hypertension, symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug;
- •Has used any investigational drug within 30 days of the screening visit;
研究组 & 干预措施
Active Treatment
Experimental
PRC-063 25, 35, 45, 55, 70, 85, or 100 mg
干预措施: PRC-063 oral capsules (Drug)
Placebo Treatment
Placebo Comparator
Matched placebo
干预措施: Placebo oral capsules (Drug)
结局指标
主要结局
Post-dose PERMP-T (Permanent Measure of Productivity - Total Score) Scores Measured During the Full-day Adult Laboratory Classroom Visit
时间窗: Full-day ALC - 13 hours
PERMP-T measures the number of completed and number of attempted math problems completed during a 10 minute test. The scale ranges from 0 to 800, with a higher score indicating a better outcome.
次要结局
未报告次要终点
研究者
研究点 (6)
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