NCT05361707招募中3 期
A Study to Evaluate the Efficacy and Safety of Tasimelteon in Treating Sleep Disturbances in Individuals With Autism Spectrum Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in sleep time over the treatment period, as measured by sleep diary.
研究概览
简要总结
This is a multicenter, open-label study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon in treating sleep disturbances in pediatric and adult participants with ASD.
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
- 2 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability and acceptance to provide written informed consent of the participant or legal guardian (and assent as required).
- •A confirmed clinical diagnosis of Autism Spectrum Disorder (ASD) and a recent history of sleep disturbances.
- •The sleep disturbance must not be a result of another diagnosable disorder or medication.
- •Male or female between 2 and 65 years of age, inclusive.
- •Willing and able to comply with study requirements and restrictions.
排除标准
- •Inability to dose daily with tasimelteon or previous intolerance to tasimelteon.
- •Indication of impaired liver function.
- •Evidence of increased risk of self-harm.
- •Pregnant or lactating females.
- •A positive test for drugs of abuse.
- •Other diagnosable causes of sleep disorders or use of medications that may cause sedation or stimulation.
研究组 & 干预措施
Tasimelteon
Experimental
Drug: Tasimelteon
干预措施: Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension (Drug)
结局指标
主要结局
Change in sleep time over the treatment period, as measured by sleep diary.
时间窗: 12 weeks
次要结局
- Improvement in objective sleep-wake parameters such as severity of condition, as measured by administered questionnaires.(12 weeks)
- Improvement in objective behavioral parameters such as the participant's overall behavior, as measured by sleep diary in the Patient Global Impression of Severity Behavior Questionnaire (PGI-S Behavior).(12 weeks)
- Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs).(12 weeks)
研究者
研究点 (1)
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