Safety and Efficacy Study of YZJ-1139 in Primary Chronic Insomnia Disorder
NCT ID: NCT06680505
Last Updated: 2024-11-08
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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COMPLETED
PHASE2
300 participants
INTERVENTIONAL
2019-08-04
2021-03-29
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 10mg
YZJ-1139 10mg
YZJ-1139 10mg tablets
YZJ-1139 20mg
YZJ-1139 20mg
YZJ-1139 20mg tablets
YZJ-1139 40mg
YZJ-1139 40mg
YZJ-1139 40mg tablets
YZJ-1139 60mg
YZJ-1139 60mg
YZJ-1139 60mg tablets
Placebo
Placebo
Match placebo tablets
Interventions
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YZJ-1139 10mg
YZJ-1139 10mg tablets
YZJ-1139 20mg
YZJ-1139 20mg tablets
YZJ-1139 40mg
YZJ-1139 40mg tablets
YZJ-1139 60mg
YZJ-1139 60mg tablets
Placebo
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Eligibility Criteria
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Inclusion Criteria
2. Meet the clinical diagnostic criteria for primary chronic insomnia disorder as defined in ICSD-3 criteria.
3. PSG results for 2 consecutive nights during the run-in period should meet the following conditions:
1\) The mean LPS of 2 nights is ≥ 30 min, with the LPS ≥ 15 min for any night; 2) And/or the mean WASO of 2 nights is ≥ 30 min, with neither night ≥20 min; 3) The mean SE of 2 nights is ≤ 85%, with the SE ≤ 87.5% for both nights. 4. During the study, the patient agreed to follow the daily bedtime between 9 and 12 pm , stayed in bed for 6.5-9 hours every night, and agreed to refrain from taking a nap.
5\. 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 1 month after the end of the study.
6\. 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
2. Apnea-hypopnea index \[AHI\] and/or periodic limb movement index \[PLMI\] \> 10 times/hour detected by PSG monitoring during the run-in period.
3. Patients with severe endocrine diseases, blood diseases, cardiovascular and cerebrovascular diseases, autoimmune diseases, respiratory function impairment and other related diseases.
4. Previous history of nervous system disorders such as epilepsy, schizophrenia, bipolar mental disorder, neurodevelopmental retardation, cognitive disorder, narcolepsy, and restless leg syndrome.
5. Receiving any hypnotics, antidepressants, antipsychotics, anticholinergics, memory-enhancing drugs, antihistamines, CYP3A inducers, CYP3A inhibitors within 2 weeks prior to the start of the lead-in PSG.
6. History of drug taking or addiction, which is known through questioning.
7. Have any lifestyle that interferes with the study process or may interfere with sleep: for example, there will be travels across zones within the next 2 weeks or during the study period, or there will be shift work (night and daytime shift).etc.
8. Special occupants who need to operate machinery during the test period, such as professional drivers, high-altitude operators, etc.
9. Subjects who were treated with any other approved or investigational insomnia medication prior to the study, including other orexin receptor inhibitors, or specific herbal preparations, traditional Chinese medicines, and still needed to continue in the study.
10. AST and ALT \> 2 × the upper limit of normal (ULN), or Cr \> 1.5 × ULN, or white blood cells \< lower limit of normal.
11. Hyperthyroidism or hypothyroidism.
12. 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).
13. History of drug abuse , or positive urine drug screening (screening and/or baseline) for any indicator.
14. Regular daily consumption of excessive tea and coffee drinks.
15. Patients who have participated in other drug clinical trials within the past 3 months, or participated in other research trials during this trial.
16. Pregnant or lactating women.
17. History of allergy to the investigational product or its components.
18. 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 HuiLongGuan 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
The First Hospital of Jilin University
Changchun, , China
Hunan Brain Hospital
Changsha, , China
Xiangya Hospital, Central South University
Changsha, , China
West China Hospital, Sichuan University
Chengdu, , China
Army Specialty Medical Center
Chongqing, , China
Guangdong Provincial People's Hospital
Guangzhou, , China
Nanfang Hospital of Southern Medical University (Department of Psychiatry)
Guangzhou, , China
Nanfang Hospital, Southern Medical University (Sleep Medicine Center)
Guangzhou, , China
The First Affiliated Hospital of Jinan University
Guangzhou, , China
The Second Affiliated Hospital of Anhui Medical University
Hefei, , China
The Affiliated Hospital of Jiujiang University
Jiujiang, , China
The First Affiliated Hospital of Kunming Medical University
Kunming, , China
The First People's Hospital of Yunnan Province
Kunming, , China
Jiangxi Provincial Psychiatric Hospital
Nanchang, , China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing
Nanjing, , China
The First People 's Hospital of Nantong
Nantong, , China
Qingdao Municipal Hospital
Qingdao, , China
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, , China
Huashan Hospital Affiliated to Fudan University
Shanghai, , China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, , China
The First Hospital of Hebei Medical University
Shijiazhuang, , China
The Third Hospital of Hebei Medical University
Shijiazhuang, , China
The Second Affiliated Hospital of Soochow University
Suzhou, , China
Tianjin Anding Hospital
Tianjin, , China
Wuhan Mental Health Center
Wuhan, , China
Tangdu Hospital, Fourth Military Medical University, PLA
Xi'an, , China
The Second Affiliated Hospital of Xinxiang Medical University
Xinxiang, , China
Henan Provincial People's Hospital
Zhengzhou, , China
The Affiliated Hospital of Zunyi Medical College
Zunyi, , China
Countries
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Other Identifiers
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YZJ-1139-2-01
Identifier Type: -
Identifier Source: org_study_id
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