Phase II/III Clinical Trial of NPC-15 - Verification of the Efficacy for Sleep Disorders of Children With Autism Spectrum Disorders -
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 196
- 主要终点
- Sleep latency with electronic sleep diary
研究概览
简要总结
The purpose of this study is to verify the efficacy of NPC-15 (melatonin 1 mg/d or 4 mg/d) versus placebo to sleep latency with electronic sleep diaries.
详细描述
This study will be a multicenter, double-blind, randomized, placebo-controlled parallel group trial. The trial has five phases; the pre-screening phase, the screening phase, double-blinded treatment phase, open label treatment phase and post-treatment phase. The screening phase comprises a screening visit where subject's initial eligibility will be evaluated. During double-blinded treatment phase, patients who meet all entry criteria for the trial will be randomized into three groups, and they will be assigned NPC-15 1 mg, 4 mg or placebo before going to bed for 2 weeks. 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
- 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 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 "autism spectrum 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 "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 Granules Lower Dose
NPC-15 Granules Lower Dose group which is administered 1mg melatonin
干预措施: NPC-15 Granules Lower Dose (Drug)
NPC-15 Granules Higher Dose
NPC-15 Granules Higher Dose group which is administered 4 mg melatonin
干预措施: NPC-15 Granules Higher Dose (Drug)
NPC-15 Placebo Granule
NPC-15 Placebo Granules group which is administered placebo melatonin
干预措施: NPC-15 Placebo Granule (Drug)
结局指标
主要结局
Sleep latency with electronic sleep diary
时间窗: Week 2
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 measured by actigraphy(Week 2)
- Abnormal behavior checklist Japanese version(Week 2, 9)
- Adverse events(10 weeks)
- Electro cardiogram(10 weeks)