NCT00640848已完成1 期
Multi-center, Multiple-stage, Double-blind, Randomized, Placebo-controlled, Two-way Crossover, Single-dose Study to Investigate the Effects of ACT-078573 on Sleep Measured by Polysomnography in Patients With Primary Insomnia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 27
- 主要终点
- Sleep efficiency (%) assessed by PSG (polysomnography)
研究概览
简要总结
The aim of the study is to determine the minimum effective dose of ACT-078573 on sleep efficiency and to assess the effects of different doses of ACT-078573 on other PSG parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women 18 - 65 years of age (inclusive).
- •Women of childbearing potential must have a negative urine pregnancy test at the screening visit, the screening adaptation night, and pre-treatment and use a reliable method of contraception during the entire study duration and for at least 3 months after study drug intake.
- •Reliable methods of contraception are:
- •Barrier type devices (e.g., female condom, diaphragm, contraceptive sponge) only in combination with a spermicide.
- •Intra-uterine devices.
- •Oral, injectable, implantable or transdermal contraceptives only in combination with a barrier method.
- •Abstention, rhythm method, and contraception by the partner alone are not acceptable methods of contraception.
- •Women not of childbearing potential are defined as prepubescent, postmenopausal (i.e., amenorrhea for at least 1 year), or surgically or naturally sterile.
- •Body mass index (BMI) between 18 and 30 kg/m2 (limits included) at screening visit.
- •12-lead ECG without clinically relevant abnormalities at screening visit.
- •Hematology and biochemistry test results not deviating from the normal range to a clinically relevant extent at screening visit and following the screening/adaptation night.
- •Primary insomnia by DSM-IV-TR criteria based on medical history and the assessments performed at screening visit.
- •History of the following for at least 3 months prior to the screening visit:
- •Usual reported subjective total sleep time (TST) 3 - 6 hours.
- •Usual sleep disturbance with a subjective sleep onset latency of > 30 min.
- •Daytime complaints associated with poor sleep (e.g., fatigue, irritability, difficulty concentrating).
- •Polysomnography (PSG) at screening/adaptation night confirming TST < 6 h and LPS ≥ 20 min.
- •Willingness to refrain from CNS-active drugs for 5 half-lives of the respective drug (but at least 1 week) prior to the screening/adaptation night and up to the end of treatment period
- •The usage of short-acting hypnotics (defined as hypnotics with a half-life of up to and including 10 hours) is allowed up to 48 hours prior to each PSG night, i.e., prior to the screening/adaptation night and prior to the treatment PSG nights.
- •Urine drug test negative for barbiturates, cannabinoids, amphetamines, and cocaine at screening visit 1, screening/adaptation PSG night and pre-treatment. Urine drug test negative for benzodiazepines and opiates at screening/adaptation PSG night and pre-treatment.
- •Signed informed consent prior to any study-mandated procedure.
排除标准
- •Symptom assessment questionnaire (SBB) for diagnosis of apnea resulting in a score > 2 at screening visit.
- •Zung self-rating depression scale (SDS) and/or Zung self-rating anxiety scale (SAS) resulting in a raw score ≥ 50 at screening visit.
- •Restless legs syndrome and/or meeting all four essential diagnostic criteria for RLS (see Appendix 10).
- •Insomnia due to sleep apnea or periodic limb movement disorder as assessed by PSG at screening/adaptation night:
- •apnea/hypopnea index (AHI) > 10/h
- •periodic limb movement arousal index > 10/h
- •Major depressive disorder, severe psychosis, or significant anxiety disorder.
- •Pregnancy or breast-feeding.
- •Systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg at screening visit.
- •Within the 2-month period prior to the screening visit, clinical evidence of alcoholism or drug abuse.
- •Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as psychiatric disease or a disease which may affect the pharmacokinetics of the study drug.
- •Treatment with strong inhibitors of CYP3A4 (e.g., azole derivatives, ritonavir, clarithromycin) within 1 week prior to the screening/adaptation PSG night and up to the end of treatment period
- •Excessive caffeine consumption (regular caffeine consumption of > 7 units per day).
- •Night shift workers.
- •Known hypersensitivity to any excipients of the drug formulation.
- •Planned treatment or treatment with another investigational drug within 1 month prior to randomization and up to the end of treatment period
- •Known concomitant life-threatening disease with a life expectancy < 24 months.
- •Unstable medical abnormality, significant medical disorder or acute illness.
- •Recruitment of the same patient twice to the same dose level. Patients may be recruited to a lower dose level, provided that there are at least 28 days between last study drug administration and screening/adaptation PSG night.
研究组 & 干预措施
1
Experimental
干预措施: almorexant (Drug)
2
Experimental
干预措施: almorexant (Drug)
3
Experimental
干预措施: almorexant (Drug)
4
Experimental
干预措施: almorexant (Drug)
5
Experimental
干预措施: almorexant (Drug)
结局指标
主要结局
Sleep efficiency (%) assessed by PSG (polysomnography)
时间窗: Between 10pm-12am (=lights out) until 480 minutes thereafter (=lights on)
次要结局
- LPS (Latency to Persistent Sleep) [min] assessed by PSG (polysomnography)(Time from start of recording to the beginning of the first continuous 20 epochs of non-wake)
研究者
研究点 (27)
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