EUCTR2015-001463-39-PL进行中（未招募）1 期
A Long-Term Multicenter, Randomized, Double-Blind, Controlled, Parallel-Group Study of the Safety and Efficacy of Lemborexant in Subjects With Insomnia Disorder
Eisai Ltd.0 个研究点目标入组 900 人开始时间: 2016年12月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 900
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Male or female, age 18 years or older at the time of informed consent
- •2. Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Insomnia Disorder, as follows:
- •- Complains of dissatisfaction with nighttime sleep in the form of difficulty getting to sleep, difficulty staying asleep and/or awakening earlier in the morning than desired despite adequate opportunity for sleep
- •- Frequency of complaint =3 times per week
- •- Duration of complaint =3 months
- •- Associated with complaint of daytime impairment
- •3. At Screening: History of sSOL =30 minutes on at least 3 nights per week in the previous 4 weeks AND/OR sWASO =60 minutes on at least 3 nights per week in the previous 4 weeks
- •4. At Screening: Reports regular time spent in bed, either sleeping or trying to sleep, between 7 and 9 hours
- •5. At 1st Screening Visit (Visit 1) and 2nd Screening Visit (Visit 2a): Reports regular bedtime, defined as the time the subject attempts to sleep, between 21:00 and 01:00 and regular waketime, defined as the time the subject gets out of bed for the day, between 05:00 and 10:00
- •6. At Screening and Study Baseline: ISI score =15
- •7. At the 2nd Screening Visit (Visit 2a): Confirmation of current insomnia symptoms as determined from responses on the Sleep Diary completed on at least 7 consecutive mornings (minimum 5 of 7 for eligibility), such that sSOL =30 minutes on at least 3 of the 7 nights and/or sWASO =60 minutes on at least 3 of the 7 nights
- •8. At the 2nd Screening Visit (Visit 2a): Confirmation of regular bedtimes and waketimes, as determined from responses on the Sleep Diary completed on a minimum of 7 consecutive mornings between the 1st and 2nd screening visit, such that the subject has a regular time spend in bed, either sleeping or traying to slee, between 7 and 10 hours
- •9. At the 2nd Screening Visit (Visit 2a): Confirmation of sufficient duration of time spent in bed, as determined from responses on the Sleep Diary completed on 7 mornings between the 1st and 2nd screening visit, such that there are not more than 2 nights with duration of time spent in bed <7 hours or >10 hours
- •10. At Baseline (Visit 3a): Reconfirmation of insomnia symptoms, as determined from responses on the Sleep Diary for the final 7 nights of the Run-in Period, such that sSOL =30 minutes on at least 3 of the 7 nights and/or sWASO =60 minutes on at least 3 of the 7 nights
- •11. At Baseline (Visit 3a): Confirmation of regular bedtimes and waketimes, such that the subject has a regular time spent in bed, either sleeping or trying to sleep, between 7 and 10 hours for the final 7 nights of the Run-In Period
- •12. At Baseline (Visit 3a): Reconfirmation of regular bedtime, defined as the time the subject attempts to sleep, between 21:00 and 01:00 and regular waketime, defined as the time the subject gets out of bed for the day, between 05:00 and 10:00 for the final 7 nights of the Run-In period
- •13. Willing and able to comply with all aspects of the protocol, including staying in bed for at least 7 hours each night
- •14. Willing to not start a behavioral or other treatment program for insomnia during the subject’s participation in the study
排除标准
- •1. A current diagnosis of sleep-related breathing disorder including obstructive sleep apnea (with or without continuous positive airway pressure [CPAP] treatment), periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorder, or narcolepsy, or an exclusionary score on the SDSB as follows: STOPBang score =5, IRLS score =16, ESS score >15 (scores of 11-15 require excessive daytime sleepiness must be recorded in subject's Medical History)
- •2. Reports symptoms potentially related to narcolepsy, that in the clinical opinion of the investigator indicate the need for referral for a diagnostic evaluation for the presence of narcolepsy
- •3. Reports a history of sleep-related violent behavior, or sleep driving, or any other complex sleep-related behavior ( eg. making phone calls, or preparing and eating food while asleep)
- •4. For subjects who underwent diagnostic PSG within 1 year before informed consent: Age 18 to 64 years: Apnea-Hypopnea Index =10, or Periodic Limb Movements with Arousal Index =10; Age =65 years: Apnea-Hypopnea Index >15, or Periodic Limb Movements with Arousal Index >15
- •5. Beck Depression Inventory – II (BDI-II) score >19 at Screening
- •6. Beck Anxiety Inventory (BAI) score >15 at Screening
- •7. Habitually naps more than 3 times per week
- •8. Females who are breastfeeding or pregnant at Screening or Study Baseline (as documented by a positive serum beta-human chorionic gonadotropin [ß-hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the 1st dose of study drug.
- •9. Females of childbearing potential who:
- •-Had unprotected sexual intercourse within 30 days before study entry or who do not agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a contraceptive implant, injectable contraceptives, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period or for 28 days after study drug discontinuation. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- •10. Excessive caffeine use that in the opinion of the investigator contributes to the subject’s insomnia, or habitually consumes caffeine-containing beverages after 18:00 and is unwilling to forego caffeine after 18:00 for the duration of his/her participation in the study
- •11. History of drug or alcohol dependency or abuse within approximately the previous 2 years.
- •16. Current evidence of clinically significant disease (eg, cardiac; respiratory including chronic obstructive pulmonary disease, acute and/or severe respiratory depression; severe hepatic insufficiency; gastrointestinal; renal including severe renal impairment; neurological [including subjects who lack capacity and/or whose cognitive decline indicates disorientation to person/place/ time and/or situation] or psychiatric disease or malignancy within the past 5 years [other than adequately treated basal cell carcinoma]) or chronic pain that in the opinion of the investigator(s) could affect the subject’s safety or interfere with the study assessments. Subjects for whom a sedating drug would be contraindicated for
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