A Phase 2 Randomized Double-Blind, Parallel, Adaptive-Design, Clinical Trial to Evaluate the Safety and Efficacy of NRCT-101SR With NRCT-202XR Compared to NRCT-202XR Alone in Subjects With Attention-Deficit/Hyperactivity Disorder
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 5
- 主要终点
- CGI-S
研究概览
简要总结
A combination therapy of NRCT-101 with NRCT-202 is being developed for patients with ADHD.
详细描述
A multi-center, randomized, double-blind, parallel, adaptive-design clinical trial to evaluate the safety and efficacy of co-administration of NRCT-101SR and low dose NRCT- 202XR compared to low or high dose of NRCT-202XR and placebo NRCT-101SR over a 6-week period in approximately 60 pediatric subjects (13-17 years of age) with ADHD.
Subjects' enrollment will be conducted in two stages.
In stage 1, subjects are planned to be randomized to one of the following two arms (1:1 ratio):
Arm 1: NRCT-101SR and low dose NRCT-202XR Arm 2: NRCT-101SR placebo and high dose NRCT-202XR
In stage 2, a third study arm will be added (Arm 3 - NRCT-101SR placebo and low dose NRCT-202XR.
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
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 13-17 years of age at screening.
- •Has a prior primary diagnosis of ADHD according to the DSM-5 classification evident by a medical record and confirmed with MINI using DSM-5 probes.
- •Is taking ADHD medication 4-7 days/week, for at least 4 weeks at Screening and at least 6 weeks at Baseline.
- •Has side effects identified using SDSE-RS at Screening and Baseline.
- •CGI-S ≥ X (blinded) at Screening and Baseline.
- •Must be fluent in English and communicate effectively with others.
- •Both subject and parent/guardian willing and able to give informed assent/consent.
- •Parent/guardian willing to serve as informant.
排除标准
- 未提供
研究组 & 干预措施
Arm 1
NRCT-101SR and low dose NRCT-202XR
干预措施: NRCT-101SR, NRCT-202XR (Drug)
Arm 2
NRCT-101SR placebo and high dose NRCT-202XR
干预措施: NRCT-101SR, NRCT-202XR (Drug)
Arm 3
NRCT-101SR placebo and low dose NRCT-202XR
干预措施: NRCT-101SR, NRCT-202XR (Drug)
结局指标
主要结局
CGI-S
时间窗: 6 weeks
SDSE-RS
时间窗: 6 weeks
次要结局
- CBRS-P(6 weeks)
- DPREMB-R(6 weeks)
- ADHD-RS-5(6 weeks)