Safety and Efficacy Study of YZJ-1139 in Insomnia Disorder
NCT ID: NCT05525637
Last Updated: 2024-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1041 participants
INTERVENTIONAL
2021-12-17
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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YZJ-1139 20mg
YZJ-1139 20mg
YZJ-1139 20mg tablets, once daily in the evening
YZJ-1139 40mg
YZJ-1139 40mg
YZJ-1139 40mg tablets, once daily in the evening
Placebo
Placebo
Match placebo tablets, once daily in the evening
Interventions
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YZJ-1139 20mg
YZJ-1139 20mg tablets, once daily in the evening
YZJ-1139 40mg
YZJ-1139 40mg tablets, once daily in the evening
Placebo
Match placebo tablets, once daily in the evening
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing Chao-Yang Hospital, Capital Medical University
Beijing, , China
Beijing Hui Long Guan Hospital, Capital Medical University
Beijing, , China
Beijing Tiantan Hospital, Capital Medical University
Beijing, , China
Beijing Tsinghua Changgung Hospital
Beijing, , China
China-Japan Friendship Hospital
Beijing, , China
Peking University First Hospital
Beijing, , China
Peking University People's Hospital
Beijing, , China
Xuanwu Hospital Capital Medical University
Beijing, , China
The First affiliated hospital of bengbu medical college
Bengbu, , China
Binzhou Medical University Hospital
Binzhou, , China
The First Bethune Hospital Of Jilin University
Changchun, , China
The First Hospital of ChangSha
Changsha, , China
The Second XiangYa Hospital Of Central University
Changsha, , China
The Secong People's Hospital Of HuNan Province
Changsha, , China
Xiangya Hospital Central South University
Changsha, , China
ChengDu Second People's Hospital
Chengdu, , China
The Fourth People's Hospital Of ChengDu
Chengdu, , China
Army Medical Center of PLA
Chongqing, , China
ChongQing Eleventh People's Hospital
Chongqing, , China
ChongQing Mental Health Center
Chongqing, , China
ChongQing Traditional Chinese Medical Hospital
Chongqing, , China
ChongQing University Three Gorges Hospital
Chongqing, , China
People's Hospital Of DeYang City
Deyang, , China
The First Affiliated Hospital Of FuJan Medical University
Fuzhou, , China
Guangdong Provincial People's Hospital
Guangzhou, , China
Nanfang Hospital Southern Medical University
Guangzhou, , China
The First Affiliated Hospital of Jinan University
Guangzhou, , China
The Affiliated Hospital Of GuiZhou Medical University
Guiyang, , China
HanDan Central Hospital
Handan, , China
Affiliated HangZhou First People's Hospital
Hangzhou, , China
Sir Run Run Shaw hospital
Hangzhou, , China
The 2nd Affiliated Hospital Of Harbin Medical University
Ha’erbin, , China
Chaohu hospital of anhui medical university
Hefei, , China
The Second Hospital Of AnHui Medical University
Hefei, , China
The Secong People's Hospital Of HeFei
Hefei, , China
Affiliated NanHua Hospital,University Of South China
Hengyang, , China
JiangMen Central Hospital
Jiangmen, , China
ShanDong Provincial QianFoShan Hospital
Jinan, , China
Jingjiang People's Hospital
Jingjiang, , China
Shandong Daizhuang Hospital
Jining, , China
Jiujiang University Affiliated Hospital
Jiujiang, , China
First People's Hospital of Yunnan Province
Kunming, , China
LiaoCheng People's Hospital
Liaocheng, , China
HeNan University Of Science &Technology
Luoyang, , China
The Affiliated Hospital Of Southwest Medical University
Luzhou, , China
JiangXi Provincial People's Hospital
Nanchang, , China
The First Affiliated Hospital Of NanChang University
Nanchang, , China
The Second Affiliated Hospital Of NanChang University
Nanchang, , China
NanJing Drum Tower Hospital
Nanjing, , China
Zhongda Hospital Southeast Unveristy
Nanjing, , China
NanTong First People's Hospital
Nantong, , China
NingBo KangNing Hospital
Ningbo, , China
NingBo Medical Center LiHuiLi Hospital
Ningbo, , China
QingDao Center Medical Group
Qingdao, , China
QingDao Municipal Hospital
Qingdao, , China
The affilated hospital of qingdao university
Qingdao, , China
The 2nd Affiliated Hospital Of FuJan Medical University
Quanzhou, , China
Affiliated ZhongShan Hospital,University Of FuDan
Shanghai, , China
HuaShan Hospital Fudan University
Shanghai, , China
ShangHai University Of Traditional Chinese Medical Shuguang Hospital
Shanghai, , China
ShengJing Hospital Of China Medical University
Shenyang, , China
ShenZhen People's Hospital
Shenzhen, , China
The First Hospital of Hebei Medical University
Shijiazhuang, , China
The Third Hospital of Hebei Medical University
Shijiazhuang, , China
Jilin Neuropsychiatric Hospital
Siping, , China
SuZhou GuangJi Hospital
Suzhou, , China
The First People's Hospital Of KunShan
Suzhou, , China
The Second Affiliated Hospital of Soochow University
Suzhou, , China
First Hospital Of ShanXi Medical University
Taiyuan, , China
Peking University BinHai Hospital
Tianjin, , China
Tianjin Huanhu Hospital
Tianjin, , China
Tianjin Mental Health Center
Tianjin, , China
The Center Hospital of WuHan
Wuhan, , China
Unidn Hospital TongJi Medical College HuaZhong University Of Science And Technology
Wuhan, , China
Wuhan Mental Health Centre
Wuhan, , China
Affiliated Hospital Of Jiangnan University
Wuxi, , China
WuXi People's Hospital
Wuxi, , China
Air Force Medical University
Xi'an, , China
XianYang Hospital OF Yan'an University
Xianyang, , China
HeNan Mental Hospital
Xinxiang, , China
The Affiliated Hospital Of XuZhou Medical University
Xuzhou, , China
XuZhou Central Hospital
Xuzhou, , China
HeNan Provincial People's Hospital
Zhengzhou, , China
The First Affiliated Hospital Of ZhenZhou University
Zhengzhou, , China
ZhenZhou Central Hospital
Zhengzhou, , China
ZhenJiang Mental Health Center
Zhenjiang, , China
ZhuMaDian Second People's Hospital
Zhumadian, , China
ZiGong First People's Hospital
Zigong, , China
Countries
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Central Contacts
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Facility Contacts
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Qiang Xia
Role: primary
Song Chen
Role: primary
Jiaqing Wang
Role: primary
Manting Liu
Role: primary
Qing Wang
Role: primary
Yanling Qing
Role: primary
Huaying Fan
Role: primary
Huizhen Wu
Role: primary
Qian Zhang
Role: primary
Changling Ding
Role: primary
Li Liu
Role: primary
Yu Liu
Role: primary
Feiyan Xiao
Role: primary
Li Liu
Role: primary
Dan Li
Role: primary
Hongqian Wang
Role: primary
Hongyu Song
Role: primary
Gang Liu
Role: primary
Hezhen Xie
Role: primary
Yan Huang
Role: primary
Jing Wang
Role: primary
Shan Xie
Role: primary
Anpeng Wu
Role: primary
Yuying Liang
Role: primary
Qingcai Zhen
Role: primary
Qingcui Huang
Role: primary
Peng Du
Role: primary
Chen Chen
Role: primary
Lin Wang
Role: primary
Yecai Xu
Role: primary
Li Zhang
Role: primary
Xiaolin Fang
Role: primary
Bin Yu
Role: primary
Juanjuan Liu
Role: primary
Yong Li
Role: primary
Shiju Gong
Role: primary
Dajian Gu
Role: primary
Liping Sha
Role: primary
Zhonggang Wang
Role: primary
Jie Li
Role: primary
Tiecheng Luo
Role: primary
Jianzhong Chen
Role: primary
Caie Wang
Role: primary
Xiaolin Zhang
Role: primary
Min Jiang
Role: primary
Duanwen Cao
Role: primary
Jian Li
Role: primary
Yue Yang
Role: primary
Jiali Xing
Role: primary
Xiujuan Wu
Role: primary
Taotao Yang
Role: primary
Na Zhu
Role: primary
Wenzhu Zhang
Role: primary
Xin Li
Role: primary
Liuzhi Kang
Role: primary
Yiju Gao
Role: primary
Yuran Cao
Role: primary
Xiaodan Zhao
Role: primary
Hongying Yang
Role: primary
Wenxiu Si
Role: primary
Ting Zhao
Role: primary
Mingyan Yang
Role: primary
Shuyong Yao
Role: primary
Tingting Wen
Role: primary
Yifang Zhu
Role: primary
Zhihui Yin
Role: primary
Haoshuang Ju
Role: primary
Fu Pan
Role: primary
Jingjing Sun
Role: primary
Yanlin Qin
Role: primary
Xiaojin Xu
Role: primary
Yiqing Zhao
Role: primary
Yi Zhao
Role: primary
Linna Liu
Role: primary
Xiaodong Bai
Role: primary
Supei Huang
Role: primary
Haijing Jiang
Role: primary
Qiujin Xu
Role: primary
Xiaoyun Wang
Role: primary
Mengfei Yu
Role: primary
Xue Sun
Role: primary
Hongxin Deng
Role: primary
Tong Wu
Role: primary
Other Identifiers
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YZJ-1139-3-01
Identifier Type: -
Identifier Source: org_study_id
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