Safety and Efficacy Study of YZJ-1139 in Insomnia Disorder

April 17, 2024 updated by: Shanghai Haiyan Pharmaceutical Technology Co., Ltd.

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of YZJ-1139 Tablets in the Treatment of Insomnia Disorder

The main purpose of this study is to assess efficacy and safety of YZJ-1139 in adult subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1041

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Xuanwu Hospital Capital Medical University
        • Contact:
          • Huizhen Wu
      • Beijing, China
        • Recruiting
        • Peking University People's Hospital
        • Contact:
          • Huaying Fan
      • Beijing, China
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:
          • Qing Wang
      • Beijing, China
        • Recruiting
        • Beijing Chao-Yang Hospital, Capital Medical University
        • Contact:
          • Qiang Xia
      • Beijing, China
        • Recruiting
        • Peking University first hospital
        • Contact:
          • Yanling Qing
      • Beijing, China
        • Recruiting
        • Beijing Tiantan Hospital, Capital Medical University
        • Contact:
          • Jiaqing Wang
      • Beijing, China
        • Recruiting
        • Beijing Hui Long Guan Hospital, Capital Medical University
        • Contact:
          • Song Chen
      • Beijing, China
        • Recruiting
        • Beijing Tsinghua Changgung Hospital
        • Contact:
          • Manting Liu
      • Bengbu, China
        • Not yet recruiting
        • The First Affiliated Hospital of Bengbu Medical College
        • Contact:
          • Qian Zhang
      • Binzhou, China
        • Recruiting
        • Binzhou Medical University Hospital
        • Contact:
          • Changling Ding
      • Changchun, China
        • Recruiting
        • The First Bethune Hospital of Jilin University
        • Contact:
          • Li Liu
      • Changsha, China
        • Recruiting
        • Xiangya Hospital Central South University
        • Contact:
          • Dan Li
      • Changsha, China
        • Recruiting
        • The First Hospital of Changsha
        • Contact:
          • Yu Liu
      • Changsha, China
        • Recruiting
        • The Second XiangYa Hospital Of Central University
        • Contact:
          • Feiyan Xiao
      • Changsha, China
        • Recruiting
        • The Secong People's Hospital Of HuNan Province
        • Contact:
          • Li Liu
      • Chengdu, China
        • Withdrawn
        • Chengdu Second People's Hospital
      • Chengdu, China
        • Recruiting
        • The Fourth People's Hospital Of ChengDu
        • Contact:
          • Hongqian Wang
      • ChongQing, China
        • Recruiting
        • ChongQing Eleventh People's Hospital
        • Contact:
          • Gang Liu
      • ChongQing, China
        • Recruiting
        • Chongqing Mental Health Center
        • Contact:
          • Hezhen Xie
      • ChongQing, China
        • Recruiting
        • ChongQing Traditional Chinese Medical Hospital
        • Contact:
          • Yan Huang
      • ChongQing, China
        • Recruiting
        • Chongqing University Three Gorges Hospital
        • Contact:
          • Jing Wang
      • Chongqing, China
        • Recruiting
        • Army Medical Center of PLA
        • Contact:
          • Hongyu Song
      • Deyang, China
        • Recruiting
        • People's Hospital of Deyang City
        • Contact:
          • Shan Xie
      • Fuzhou, China
        • Recruiting
        • The First Affiliated Hospital Of FuJan Medical University
        • Contact:
          • Anpeng Wu
      • Guangzhou, China
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
          • Yuying Liang
      • Guangzhou, China
        • Recruiting
        • Nanfang Hospital Southern Medical University
        • Contact:
          • Qingcai Zhen
      • Guangzhou, China
        • Recruiting
        • The First Affiliated Hospital of Jinan University
        • Contact:
          • Qingcui Huang
      • Guiyang, China
        • Not yet recruiting
        • The Affiliated Hospital of Guizhou Medical University
        • Contact:
          • Peng Du
      • Ha'erbin, China
        • Recruiting
        • The 2nd Affiliated Hospital of Harbin Medical University
        • Contact:
          • Li Zhang
      • HanDan, China
        • Recruiting
        • Handan Central Hospital
        • Contact:
          • Chen Chen
      • Hangzhou, China
        • Recruiting
        • Affiliated HangZhou First People's Hospital
        • Contact:
          • Lin Wang
      • Hangzhou, China
        • Recruiting
        • Sir Run Run Shaw Hospital
        • Contact:
          • Yecai Xu
      • Hefei, China
        • Recruiting
        • The Second Hospital of Anhui Medical University
        • Contact:
          • Bin Yu
      • Hefei, China
        • Not yet recruiting
        • Chaohu hospital of anhui medical university
        • Contact:
          • Xiaolin Fang
      • Hefei, China
        • Recruiting
        • The Secong People's Hospital Of HeFei
        • Contact:
          • Juanjuan Liu
      • Hengyang, China
        • Recruiting
        • Affiliated NanHua Hospital,University Of South China
        • Contact:
          • Yong Li
      • Jiangmen, China
        • Recruiting
        • Jiangmen Central Hospital
        • Contact:
          • Shiju Gong
      • Jinan, China
        • Recruiting
        • ShanDong Provincial QianFoShan Hospital
        • Contact:
          • Dajian Gu
      • Jingjiang, China
        • Not yet recruiting
        • Jingjiang People's Hospital
        • Contact:
          • Liping Sha
      • Jining, China
        • Not yet recruiting
        • Shandong Daizhuang Hospital
        • Contact:
          • Zhonggang Wang
      • Jiujiang, China
        • Recruiting
        • Jiujiang University Affiliated Hospital
        • Contact:
          • Jie Li
      • Kunming, China
        • Not yet recruiting
        • First People's Hospital of Yunnan Province
        • Contact:
          • Tiecheng Luo
      • Liaocheng, China
        • Recruiting
        • LiaoCheng People's Hospital
        • Contact:
          • Jianzhong Chen
      • Luoyang, China
        • Recruiting
        • HeNan University Of Science &Technology
        • Contact:
          • Caie Wang
      • Luzhou, China
        • Recruiting
        • The Affiliated Hospital of Southwest Medical University
        • Contact:
          • Xiaolin Zhang
      • Nanchang, China
        • Recruiting
        • The First Affiliated Hospital Of Nanchang University
        • Contact:
          • Duanwen Cao
      • Nanchang, China
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
          • Jian Li
      • Nanchang, China
        • Recruiting
        • Jiangxi Provincial People's Hospital
        • Contact:
          • Min Jiang
      • Nanjing, China
        • Withdrawn
        • Nanjing Drum Tower hospital
      • Nanjing, China
        • Not yet recruiting
        • Zhongda Hospital Southeast Unveristy
        • Contact:
          • Yue Yang
      • Nantong, China
        • Recruiting
        • Nantong First People's Hospital
        • Contact:
          • Jiali Xing
      • Ningbo, China
        • Not yet recruiting
        • Ningbo Kangning Hospital
        • Contact:
          • Xiujuan Wu
      • Ningbo, China
        • Recruiting
        • Ningbo medical center lihuili hospital
        • Contact:
          • Taotao Yang
      • Qingdao, China
        • Recruiting
        • Qingdao Municipal Hospital
        • Contact:
          • Wenzhu Zhang
      • Qingdao, China
        • Not yet recruiting
        • QingDao Center Medical Group
        • Contact:
          • Na Zhu
      • Qingdao, China
        • Not yet recruiting
        • The affilated hospital of qingdao university
        • Contact:
          • Xin Li
      • Quanzhou, China
        • Recruiting
        • The 2nd Affiliated Hospital Of FuJan Medical University
        • Contact:
          • Liuzhi Kang
      • Shanghai, China
        • Recruiting
        • Affiliated ZhongShan Hospital,University Of FuDan
        • Contact:
          • Yiju Gao
      • Shanghai, China
        • Recruiting
        • Huashan Hospital Fudan University
        • Contact:
          • Yuran Cao
      • Shanghai, China
        • Withdrawn
        • ShangHai University Of Traditional Chinese Medical Shuguang Hospital
      • Shenyang, China
        • Recruiting
        • Shengjing Hospital of China Medical University
        • Contact:
          • Xiaodan Zhao
      • Shenzhen, China
        • Recruiting
        • ShenZhen People's Hospital
        • Contact:
          • Hongying Yang
      • Shijiazhuang, China
        • Recruiting
        • The First Hospital of Hebei Medical University
        • Contact:
          • Wenxiu Si
      • Shijiazhuang, China
        • Recruiting
        • The Third Hospital of Hebei Medical University
        • Contact:
          • Ting Zhao
      • Siping, China
        • Not yet recruiting
        • Jilin Neuropsychiatric Hospital
        • Contact:
          • Mingyan Yang
      • SuZhou, China
        • Recruiting
        • SuZhou GuangJi Hospital
        • Contact:
          • Shuyong Yao
      • Suzhou, China
        • Recruiting
        • The Second Affiliated Hospital of Soochow University
        • Contact:
          • Yifang Zhu
      • Suzhou, China
        • Recruiting
        • The First People's Hospital Of KunShan
        • Contact:
          • Tingting Wen
      • Taiyuan, China
        • Recruiting
        • First Hospital Of ShanXi Medical University
        • Contact:
          • Zhihui Yin
      • Tianjin, China
        • Not yet recruiting
        • Peking University BinHai Hospital
        • Contact:
          • Haoshuang Ju
      • Tianjin, China
        • Not yet recruiting
        • Tianjin Huanhu Hospital
        • Contact:
          • Fu Pan
      • Tianjin, China
        • Recruiting
        • Tianjin Mental Health Center
        • Contact:
          • Jingjing Sun
      • Wuhan, China
        • Not yet recruiting
        • The Center Hospital of WuHan
        • Contact:
          • Yanlin Qin
      • Wuhan, China
        • Withdrawn
        • Unidn Hospital TongJi Medical College HuaZhong University Of Science And Technology
      • Wuhan, China
        • Recruiting
        • Wuhan Mental Health Centre
        • Contact:
          • Xiaojin Xu
      • Wuxi, China
        • Recruiting
        • Wuxi People's Hospital
        • Contact:
          • Yi Zhao
      • Wuxi, China
        • Not yet recruiting
        • Affiliated Hospital of Jiangnan University
        • Contact:
          • Yiqing Zhao
      • Xi'an, China
        • Not yet recruiting
        • Air Force Medical University
        • Contact:
          • Linna Liu
      • Xianyang, China
        • Not yet recruiting
        • XianYang Hospital OF Yan'an University
        • Contact:
          • Xiaodong Bai
      • Xinxiang, China
        • Recruiting
        • HeNan Mental Hospital
        • Contact:
          • Supei Huang
      • Xuzhou, China
        • Recruiting
        • The Affiliated Hospital Of XuZhou Medical University
        • Contact:
          • Haijing Jiang
      • Xuzhou, China
        • Recruiting
        • Xuzhou Central Hospital
        • Contact:
          • Qiujin Xu
      • Zhengzhou, China
        • Withdrawn
        • Henan Provincial People's Hospital
      • Zhengzhou, China
        • Recruiting
        • The First Affiliated Hospital Of ZhenZhou University
        • Contact:
          • Xiaoyun Wang
      • Zhengzhou, China
        • Recruiting
        • ZhenZhou Central Hospital
        • Contact:
          • Mengfei Yu
      • Zhenjiang, China
        • Recruiting
        • ZhenJiang Mental Health Center
        • Contact:
          • Xue Sun
      • Zhumadian, China
        • Recruiting
        • ZhuMaDian Second People's Hospital
        • Contact:
          • Hongxin Deng
      • Zigong, China
        • Recruiting
        • Zigong First People's Hospital
        • Contact:
          • Tong Wu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- Subjects who meet all of the following criteria may be enrolled in the study:

  1. Aged ≥ 18 to < 65 years.
  2. Meet the clinical diagnostic criteria for insomnia disorder as defined in International Classification of Sleep Disorders, 3rd Edition (ICSD-3) criteria.
  3. sTSO ≥ 30 min for at least 3 nights per week and/or sWASO ≥ 60 min for at least 3 nights per week within 28 days (4 weeks) prior to screening.
  4. During the run-in period or on Day 1 of the treatment period, sTSO ≥ 30 min for at least 3 nights in the last 7 sleep diaries and/or sWASO ≥ 60 min for at least 3 nights out of 7 nights as confirmed by the sleep diary prior to Polysomnography (PSG) monitoring.

  5. PSG results for 2 consecutive nights during the run-in period should meet the following conditions:

    • The mean LPS of 2 nights is ≥ 30 min, with the LPS ≥ 20 min for any night;
    • And/or the mean WASO of 2 nights is ≥ 60 min, with neither night < 45 min;
    • The mean SE of 2 nights is ≤ 85%, with the SE ≤ 87.5% for both nights.
  6. ISI score ≥ 15 at screening and on Day 1 of the treatment period.
  7. Agree to follow the habitual bedtime between 9 p.m. and 1 a.m., wake up between 5 a.m. and 10 a.m. every day, and stay in bed for 6.5 to 9 hours per night during the study.
  8. Have a bedtime between 9 p.m. and 1 a.m., wake up between 5 a.m. and 10 a.m., and stay in bed for 6.5 to 9 hours for at least 5 days in the last 7 sleep diaries as confirmed by the sleep diary prior to PSG monitoring during the run-in period or on Day 1 of the treatment period.
  9. Female subjects are confirmed to be non-pregnant at screening; both men of reproductive potential and women of childbearing potential should agree to use medically acceptable and effective contraception throughout the study and within 3 months after the end of the study.
  10. Understand the study procedures and contents, voluntarily participate in the clinical study and sign the written Informed Consent Form (ICF), have good compliance during participation in the study, and are willing to attend the visits.

Exclusion Criteria:

  • Subjects who meet any of the following criteria should be excluded from this study:

    1. Depression: Hamilton Depression Scale (HAMD) score ≥ 18; anxiety: Hamilton Anxiety Scale (HAMA) score ≥ 14.
    2. Suicidal ideation with or without plan at screening or within 6 months prior to screening (score ≥ 3 on item 3 [suicide] of HAMD, or select "Yes" on item 3, 4 or 5 of suicidal ideation subscale of Columbia-Suicide Severity Rating Scale (C-SSRS)), or have any suicidal behavior in the past 10 years (as assessed by the suicidal ideation subscale of C-SSRS).
    3. Apnea-hypopnea index (AHI) and/or periodic limb movement index (PLMI) > 10 times/hour detected by PSG monitoring during the run-in period.
    4. Repeat electrocardiogram (ECG) at screening shows QTcF interval prolongation (QTcF > 450 ms) (the ECG should be repeated 2 more times only if the initial ECG shows QTcF interval > 450 ms).
    5. Have serious endocrine diseases, hematological diseases, cardiovascular and cerebrovascular diseases, gastrointestinal diseases, liver and kidney diseases, autoimmune diseases, impaired respiratory function or other related diseases, or have other medical history that may affect the safety of the subjects or interfere with the study assessments in the opinion of the investigator.
    6. Have insomnia disorder due to other causes such as chronic pain, headache, eczema, neurodermatitis, allergic rhinitis, and serious dermatitis (difficulty sleeping due to physical reasons, difficulty falling asleep due to medical reasons).
    7. Previous history of nervous system disorders such as epilepsy, schizophrenia, bipolar mental disorder, neurodevelopmental retardation, and cognitive disorder, or previous history of other mental illness that may affect the safety of the subjects or interfere with the study assessments in the opinion of the investigator.
    8. Previous history of sleep-related respiratory disorders including obstructive sleep apnea (with or without continuous positive airway pressure (CPAP) therapy), periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disturbances, narcolepsy or other sleep disorders: subjects with restless legs syndrome which is diagnosed by relevant diagnostic and treatment guidelines should be excluded.
    9. Have previous complex sleep behaviors, such as sleep driving, sleep eating, and sleep phone calls.
    10. Plan to undergo surgery during the study.
    11. Have received any hypnotics, antidepressants, antipsychotic drugs, anticholinergics, memory-enhancing drugs, antihistamines, centrally acting analgesics, centrally acting muscle relaxants, central nervous system stimulants, cytochrome P450 3A (CYP3A) inducers, CYP3A inhibitors, traditional Chinese medicines and traditional Chinese medicinal products with sleep-improving effects, or any other therapies for insomnia disorder within 1 week prior to the run-in period or within 5 half-lives of the investigational product, whichever is longer.
    12. History of drug taking or addiction, which is known through questioning.
    13. Have any lifestyle that interferes with the study process or may interfere with sleep: for example, there will be travels across 3 or more time zones (mainland China is considered as 1 time zone) within the next 2 weeks or during the study period, or there will be shift work (night and daytime shift).
    14. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2 × the upper limit of normal (ULN), or Creatinine (Cr) > 1.5 × ULN.
    15. Hyperthyroidism.
    16. History of alcohol abuse (defined as regular daily alcohol consumption exceeding the following criteria: approximately 720 mL of beer, or 240 mL of wine, or 60 mL of liquor) within the past 2 years.
    17. History of drug abuse within the past 2 years, or positive urine drug screening for any indicator.
    18. Regular daily consumption of excessive tea and coffee drinks (defined as consumption of > 4 cups of caffeinated beverages or > 400 mg of caffeine per day), or daily habituation to drinking caffeinated beverages beyond 18:00.
    19. Have nocturia increased caused by urinary tract infection, urinary tract injury or prostatic disorder.
    20. Have positive infectious disease screening for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb) and human immunodeficiency virus (HIV) antibody at screening.
    21. Unable to avoid vaccination within 1 month prior to screening or during the first treatment phase.
    22. Have participated in clinical studies of other drugs within the past 1 month or 5 half-lives (whichever is longer), or plan to participate in other studies simultaneously during participation in this study.
    23. Pregnant or lactating women.
    24. History of allergy to the investigational product or its components.
    25. Have prior participation in clinical studies of YZJ-1139 Tablets.
    26. Have other conditions that make the subject unsuitable for participation in the clinical study in the opinion of the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Match placebo tablets, once daily in the evening
Experimental: YZJ-1139 20mg
Drug: YZJ-1139 20mg
YZJ-1139 20mg tablets, once daily in the evening
Experimental: YZJ-1139 40mg
Drug: YZJ-1139 40mg
YZJ-1139 40mg tablets, once daily in the evening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the subjective sleep efficiency (sSE) after 14 days of treatment
Time Frame: from baseline to week 2
Subjective Sleep efficiency variation assessed by the sleep diary questionnaire at 14 days of treatment from baseline. A positive change from baseline indicates an increase in the subjective Sleep efficiency. A negative change from baseline indicates a decrease in subjective Sleep efficiency
from baseline to week 2
Change from baseline in the sleep efficiency (SE) after 14 days of treatment
Time Frame: from baseline to day 14
Sleep efficiency variation assessed by polysomnography at 14 days of treatment from baseline. A positive change from baseline indicates an increase in the Sleep efficiency. A negative change from baseline indicates a decrease in Sleep efficiency
from baseline to day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the subjective sleep efficiency (sSE) after 7 days of treatment
Time Frame: Baseline, week 1
sSE is self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Baseline, week 1
Changes from baseline in the Subjective time to sleep onset (sTSO) after 14 days of treatment for subjects entering the second treatment phase
Time Frame: Baseline, week 1, week 2
sTSO are self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Baseline, week 1, week 2
Changes from baseline in the Subjective wake after sleep onset (sWASO) after 14 days of treatment for subjects entering the second treatment phase
Time Frame: Baseline, week 1, week 2
sWASO are self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Baseline, week 1, week 2
Changes from baseline in the Subjective total sleep time (sTST) after 14 days of treatment for subjects entering the second treatment phase
Time Frame: Baseline, week 1, week 2
sTST are self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Baseline, week 1, week 2
Changes from baseline in the Subjective number of awakenings (sNAW) after 14 days of treatment for subjects entering the second treatment phase
Time Frame: Baseline, week 1, week 2
sNAW are self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Baseline, week 1, week 2
Changes from baseline in the SE after 2 days of treatment
Time Frame: Baseline, Day1/Day2
SE assessed by polysomnography at 2 days of treatment from baseline. A positive change from baseline indicates an increase in the Sleep efficiency. A negative change from baseline indicates a decrease in Sleep efficiency
Baseline, Day1/Day2
Latency to persistent sleep (LPS) after 2 and 14 days of treatment
Time Frame: Baseline, Day1/Day2, Day13/Day14
LPS assessed by polysomnography at 2 and 14 days of treatment from baseline. A positive change from baseline indicates an increase in the Sleep efficiency. A negative change from baseline indicates a decrease in Sleep efficiency
Baseline, Day1/Day2, Day13/Day14
Wake after sleep onset (WASO) after 2 and 14 days of treatment
Time Frame: Baseline, Day1/Day2, Day13/Day14
WASO assessed by polysomnography at 2 and 14 days of treatment from baseline. A positive change from baseline indicates an increase in the Sleep efficiency. A negative change from baseline indicates a decrease in Sleep efficiency
Baseline, Day1/Day2, Day13/Day14
Total sleep time (TST) after 2 and 14 days of treatment
Time Frame: Baseline, Day1/Day2, Day13/Day14
TST assessed by polysomnography at 2 and 14 days of treatment from baseline. A positive change from baseline indicates an increase in the Sleep efficiency. A negative change from baseline indicates a decrease in Sleep efficiency
Baseline, Day1/Day2, Day13/Day14
Sleep structure (wakefulness, N1, N2, N3, rapid eye movement sleep [REM], non-rapid eye movement sleep [NREM], REM latency, number of awakenings [NAW], arousal index for REM and NREM) after 2 and 14 days of treatment
Time Frame: Baseline, Day1/Day2, Day13/Day14
Sleep structure assessed by polysomnography at 2 and 14 days of treatment from baseline.
Baseline, Day1/Day2, Day13/Day14
Change from baseline in the mean subjective sleep quality score after 7 and 14 days of treatment for subjects
Time Frame: Baseline, Week 1, Week 2
Subjective sleep quality score is a self-report assessment of participant perception of the effects of a medication on their sleep. Higher score indicated severe insomnia problem.
Baseline, Week 1, Week 2
Percentage of Participants on each scale of Global Impression of Insomnia (PGI-I) each Item at 14 days of treatment
Time Frame: Day 14
The PGI-I was a self-report assessment of participant perception of the effects of a medication on their sleep. The PGI-I had 3 items related to study medication effects (a) helped/worsened sleep, (b) decreased/increased time to fall asleep, (c) increased/decreased total sleep time, and 1 item related to perceived appropriateness of study medication strength. The first 3 items were answered on a 3-point scale (1=positive medication effect, 2=neutral medication effect, 3=negative medication effect) and the last item on a different 3 point scale (medication: 1=too strong, 2=just right, 3=too weak)
Day 14
Changes from baseline in the sSE after 30, 90 and 180 days of treatment for subjects entering the second treatment phase
Time Frame: Baseline, Day 30, Day 90, and Day 180
sSE are self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Baseline, Day 30, Day 90, and Day 180
Changes from baseline in the sTSO after 30, 90 and 180 days of treatment for subjects entering the second treatment phase
Time Frame: Baseline, Day 30, Day 90, and Day 180
sTSO are self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Baseline, Day 30, Day 90, and Day 180
Changes from baseline in the sWASO after 30, 90 and 180 days of treatment for subjects entering the second treatment phase
Time Frame: Baseline, Day 30, Day 90, and Day 180
sWASO are self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Baseline, Day 30, Day 90, and Day 180
Changes from baseline in the sTST after 30, 90 and 180 days of treatment for subjects entering the second treatment phase
Time Frame: Baseline, Day 30, Day 90, and Day 180
sTST are self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Baseline, Day 30, Day 90, and Day 180
Changes from baseline in the sNAW after 30, 90 and 180 days of treatment for subjects entering the second treatment phase
Time Frame: Baseline, Day 30, Day 90, and Day 180
sNAW are self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Baseline, Day 30, Day 90, and Day 180
Change from baseline in the mean subjective sleep quality score after 30, 90 and 180 days of treatment for subjects entering the second treatment phase
Time Frame: Baseline, Day 30, Day 90, and Day 180
Subjective sleep quality score is a self-report assessment of participant perception of the effects of a medication on their sleep. Higher score indicated severe insomnia problem.
Baseline, Day 30, Day 90, and Day 180
Change from baseline in the Insomnia Severity Index (ISI) score after 30, 90 and 180 days of treatment for subjects entering the second treatment phase
Time Frame: Baseline, Day 30, Day 90, and Day 180
ISI is a self-report questionnaire assessing the nature, severity, and impact of insomnia. Higher score indicated severe insomnia problem.
Baseline, Day 30, Day 90, and Day 180
Percentage of Participants who enter the second treatment phase on each scale of Patient Global Impressions - ImprovementGlobal Impression of Insomnia (PGI-I) each Item at 30, 90 and 180 days of treatment
Time Frame: Day 30, Day 90, and Day 180
The PGI-I was a self-report assessment of participant perception of the effects of a medication on their sleep. The PGI-I had 3 items related to study medication effects (a) helped/worsened sleep, (b) decreased/increased time to fall asleep, (c) increased/decreased total sleep time, and 1 item related to perceived appropriateness of study medication strength. The first 3 items were answered on a 3-point scale (1=positive medication effect, 2=neutral medication effect, 3=negative medication effect) and the last item on a different 3 point scale (medication: 1=too strong, 2=just right, 3=too weak).
Day 30, Day 90, and Day 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Haiyan Pharmaceutical Technology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2021

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 24, 2022

First Submitted That Met QC Criteria

August 31, 2022

First Posted (Actual)

September 1, 2022

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YZJ-1139-3-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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