JPRN-jRCT2080223414
已完成
3 期
A Long-Term Multicenter, Randomized, Double-Blind, Controlled, Parallel Group Study of the Safety and Efficacy of Lemborexant in Subjects With Insomnia Disorder
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Eisai Co., Ltd.
- 入组人数
- 971
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
Both doses of lemborexant demonstrated statistically significant improvement from Baseline compared to PBO for both sleep onset and sleep maintenance variables after 6 months of treatment. Statistically significant improvement from Baseline were also demonstrated for sSOL, sSE, and sWASO after 7 nights and at Month 3, and for sSOL and sSE also at Month 1 for both doses of lemborexant compared to placebo. Lemborexant was safe and well tolerated without clinically significant findings at LEM5 and LEM10.
研究者
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\)History of subjective sleep onset latency (sSOL) \>\=30 minutes on at least 3 nights per week in the previous 4 weeks AND subjective wake after sleep onset (sWASO) \>\=60 minutes on at least 3 nights per week in the previous 4 weeks
- •(4\)Reports regular time spent in bed, either sleeping or trying to sleep, between 7 and 9 hours
- •(5\)Reports regular bedtime, defined as the time the participant attempts to sleep, between 21:00 and 24:00 and regular waketime, defined as the time the participant gets out of bed for the day, between 05:00 and 09:00
- •(6\)Insomnia Severity Index (ISI) score \>\=15
排除标准
- •(1\)A current diagnosis of sleep\-related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorder, or narcolepsy, or an exclusionary score on screening instruments to rule out individuals with symptoms of certain sleep disorders other than insomnia
- •(2\)Reports symptoms potentially related to narcolepsy that in the clinical opinion of the investigator indicates the need for referral for a diagnostic evaluation for the presence of narcolepsy
- •(3\)On the Munich Parasomnia Scale (MUPS), (a) a history of symptoms of Rapid Eye Movement (REM) Behavior Disorder, sleep\-related violent behavior, sleep\-driving, or sleep\-eating; or (b) symptoms of another parasomnia that in the investigator's opinion make the participant unsuitable for the study
- •(4\)For participants who underwent polysomnography (PSG) the previous year:
- •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
结局指标
主要结局
未指定
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