Phase III Clinical Trial of NPC-15 - Study of the Efficacy and Safety for Sleep Disorders of Children With Neurodevelopmental Disorders -
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 主要终点
- Sleep latency with electronic sleep diary at week 10.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy on sleep latency with electronic sleep diaries and the safety of NPC-15.
详细描述
This study will be a multicenter and open label trial. The trial has three phases; the screening phase, treatment phase and post-treatment phase. The screening phase comprises a screening visit where subject's initial eligibility will be evaluated. During open label treatment phase, all patients will be administered NPC-15 1 mg, 2 mg or 4 mg on the basis of their doctors' judgements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male patients aged 6 to 15 years.
- •Patients with "neurodevelopmental disorder" diagnosed by using DSM-
- •Patients with average of daily sleep latency persisted over 30 min and the condition is continuous over 3 months
- •Patients who are out-patient, not hospitalized patient.
- •Signed informed consent obtained from rearer(s)/parent(s)/guardian(s) of the patient, or signed IC or informed assent obtained from the patient themselves.
排除标准
- •Patients with at least severity in either Conceptual area, or Social area, or Practical area of intellectual disability have judged more than " the most severe" by using DSM-
- •Patients who took melatonin (including supplement) in history.
- •Patients who had taken Ramelteon within 4 weeks before clinical study starts.
研究组 & 干预措施
NPC-15 Granule
NPC-15 granule 1 mg, 2 mg or 4 mg once a day, administered orally before going to bed.
干预措施: NPC-15 (Drug)
结局指标
主要结局
Sleep latency with electronic sleep diary at week 10.
时间窗: 10 weeks
Sleep latency is a common endpoint in sleep disorders. In addition, it has been used in a randomized clinical study of sleep disorders of children with neurodevelopmental disorders.
次要结局
- Sleep latency with electronic sleep diary at week 26.(26 weeks)
- Abnormal behavior checklist Japanese version(Week 10, 26)
- Adverse events(28 weeks)
- Laboratory findings, vital sign(28 weeks)
- Electro cardiogram(28 weeks)