A Phase I/IIa Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Immediate-Release Viloxazine in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 主要终点
- Incidence of Adverse Events During 6 Weeks of Treatment
研究概览
简要总结
This will be a randomized, double-blind, placebo-controlled, parallel group, safety and tolerability study in adults with ADHD. The target subjects are healthy male or female adults aged 18 to 64 years, inclusive, with a diagnosis of ADHD.
详细描述
This will be a randomized, double-blind, multicenter, placebo-controlled, parallel group, safety and tolerability study in adults with ADHD. The target subjects are healthy male or female adults aged 18 to 64 years of age, inclusive, with a diagnosis of ADHD. Approximately 50 subjects will be enrolled at approximately 5 sites in the United States. Subjects will be randomized (1:1) to one of two treatment groups, immediate-release (IR) viloxazine or placebo. Primary objective is to determine the safety of IR viloxazine in adults with ADHD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
IR Viloxazine
Treatment A: immediate-release (IR) viloxazine capsules administered orally 3 times a day
干预措施: IR Viloxazine (Drug)
Placebo
Treatment B: Placebo capsules administered orally 3 times a day
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Adverse Events During 6 Weeks of Treatment
时间窗: Weeks 1-6
The percent of subjects who took at least one dose of immediate-release viloxazine (Safety Population; N) and who reported at least one Adverse Event (n). The percent is calculated by dividing "the number of subjects who reported at least one Adverse Event (n)" by "the number of subjects in the Safety Population (N)" and multiplying the product by 100. The higher the percentage, the higher the incidence in the Safety Population
次要结局
- Change From Baseline in the Investigator-Rated Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (CAARS) Total Score at Week 6 (End of Study)(Baseline and Week 6)
- Change From Baseline in the Investigator-Rated Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (CAARS) Total Score at Week 1(Baseline and Week 1)
- Change in Global Clinical Impression-Improvement (CGI-I) Score From Baseline Global Clinical Impression-Severity of Illness (CGI-S) Score at Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6(Weeks 1, 2, 3, 4, 5, and 6)
- Change From Baseline in the Investigator-Rated Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (CAARS) Total Score at Week 2, Week 3, Week 4, and Week 5(Baseline and Weeks 2, 3, 4, and 5)
- Change From Baseline in the Self-rated Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (CAARS) Total Score at Week 6(Baseline and Week 6)
- Global Clinical Impression-Improvement (CGI-I) Score at Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6(Weeks 1, 2, 3, 4, 5, and 6)