Multi-center, Double-blind, Parallel-group, Randomized, Placebo-controlled, Three Doses, 40-week Extension to Studies ID-078A301 and ID-078A302 to Assess the Long Term Safety and Tolerability of ACT-541468 in Adult and Elderly Subjects With Insomnia Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 804
- 试验地点
- 105
- 主要终点
- Total no. of Subjects With at Least One TEAE
研究概览
简要总结
Study to assess the long term safety and tolerability of daridorexant in adult and elderly subjects suffering from difficulties to sleep
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent prior to any study-mandated procedure (Visit 1).
- •Having completed the DB study treatment and the run-out period of ID-078A301 (NCT03545191) or ID-078A302 (NCT03575104).
- •For woman of childbearing potential, the following is required:
- •Negative urine pregnancy test (EOT of ID-078A301 or ID-078A302 studies)
- •Agreement to use the contraception scheme as required by the protocol from Visit 1 up to at least 30 days after EODBT.
排除标准
- •Unstable medical condition, significant medical disorder or acute illness, C-SSRS©, ECG, hematology or biochemistry test results in ID-078A301 and ID-078A302, which in the opinion of the investigator could affect the subject's safety or interfere with the study assessments (Visit 1).
- •For female subjects: lactating or planning to become pregnant during the duration of the study (Visit 1).
- •Positive urine drug test (for benzodiazepines, barbiturates, cannabinoids, opiates, amphetamines, or cocaine) or presence of alcohol in exhaled breath as detected by breathalyzer test (EOT of ID-078A301 or ID-078A302 studies if same day as Visit 1 or Visit 1 if within 7 days after EOT).
研究组 & 干预措施
Daridorexant 10 mg
Film-coated tablets administered orally, once daily in the evening
干预措施: Daridorexant 10 mg (Drug)
Daridorexant 25 mg
Film-coated tablets administered orally, once daily in the evening
干预措施: Daridorexant 25 mg (Drug)
Daridorexant 50 mg
Film-coated tablets administered orally, once daily in the evening
干预措施: Daridorexant 50 mg (Drug)
Placebo
Film-coated tablets administered orally, once daily in the evening
干预措施: Placebo (Drug)
Ex-Placebo Daridorexant 25 mg
Film-coated tablets administered orally, once daily in the evening
干预措施: Daridorexant 25 mg (Drug)
结局指标
主要结局
Total no. of Subjects With at Least One TEAE
时间窗: TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
The primary objective of the study was to assess the long-term safety and tolerability of 10, 25 and 50 mg daridorexant. The total no. of subjects with at least one TEAE is presented here; no statistical analysis was conducted. The full set of safety data is available in the Section "Adverse events".
次要结局
未报告次要终点