2024-516411-24-00招募中3 期
A MULTICENTER, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFECTS OF TASIMELTEON VS. PLACEBO IN TREATING PEDIATRIC INSOMNIA
Vanda Pharmaceuticals Netherlands B.V., Vanda Pharmaceuticals Inc.2 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2025年9月23日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Sleep Latency as measured by daily sleep diary
研究概览
简要总结
To evaluate the efficacy of tasimelteon administered daily compared to placebo on Sleep Latency in participants, as measured by daily diary.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Open-Label Extension Phase
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •A confirmed clinical diagnosis of insomnia disorder as per DSM-V or ICSD-3 criteria.
- •Reported sleep latency of ≥ 1 hour on average 4 nights/week for at least 3 months prior to screening (For PK sub-study, only reported sleep complaint 4 nights/week is required).
- •Sleep latency of ≥ 1 hour on average 4 nights/week and at least 3 nights/week in each of the 4 weeks preceding randomization by sleep diary (Not required for PK sub-study).
- •The sleep disturbance must not be a result of another medication.
- •Male or female between 2 and 17 years of age, inclusive, at Visit 1 (V1).
- •Informed consent from the legal guardian (and assent, as required).
- •Completing the required Daily Sleep Diary for an average of 5 out of 7 nights during screening.
- •Both guardian and child are willing and able to comply with study requirements and restrictions.
排除标准
- •Use of prohibited medications (as detailed in Section 9.2.1 clinical Study Protocol).
- •Previous intolerance to tasimelteon.
- •Unable to dose daily with medication.
- •Pregnant or breastfeeding females.
- •A positive test for drugs of abuse.
- •Exposure to any investigational drug, including placebo, within 30 days or 5 half-lives (whichever was longer) of screening.
- •Unwilling or unable to follow the medication restrictions including the washout from use of a prohibited medication.
- •Any other sound medical reason as determined by the clinical investigator or the sponsor.
结局指标
主要结局
Sleep Latency as measured by daily sleep diary
Sleep Latency as measured by daily sleep diary
次要结局
- Nighttime subjective sleep parameters as measured by daily sleep diary
- Patient Global Impression of Change scale (PGI-C)
- Clinical Global Impression of Change scale (CGI-C)
- Caregiver Global Impression of Change scale (CaGI-C)
- Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD)
- Sheehan Disability Scale for Pediatrics and Adolescents (SDS-P/A)
- Aberrant Behavior Checklist (ABC)
- Actigraphy parameters
- Tasimelteon pharmacokinetics (PK) in 2-year-old participants
研究者
Christos Polymeropoulos
Scientific
Vanda Pharmaceuticals Netherlands B.V.
研究点 (2)
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