Clinical trial NCT06680505: Safety and Efficacy Study of YZJ-1139 in Primary Chronic Insomnia Disorder
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase Ⅱ Clinical Study to Evaluate the Efficacy and Safety of YZJ-1139 Tablets in the Treatment of Primary Chronic Insomnia Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Insomnia Disorder
Lead sponsor: Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate the efficacy and safety of YZJ-1139 in the short-term treatment of primary chronic insomnia, explore the optimal effective dose, and provide the basis for phase III clinical trials


Eligibility criteria: Inclusion Criteria:

1. Aged ≥ 18 to \< 65 years.
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:

1. Sleep disorders associated with neurological disorders such as depression, anxiety, sleep disorders due to dementia; depression: Hamilton Depression Scale (HAMD) score ≥ 18 or item 3 (suicidal ideation) score of 3 or more; anxiety: Hamilton Anxiety Scale (HAMA) score ≥ 14; dementia: MMSE scale score ≤ 20 for primary school, ≤ 22 for secondary school (including technical secondary school), and ≤ 23 for college (including junior college).
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.

Primary outcomes:
measure: Sleep efficiency (SE) monitored by PSG
timeFrame: Baseline , for all subjects: Day 1 / Day 2,Day 13 / Day 14; for 1/5 subjects: Day 27 / Day 28
Secondary outcomes:
measure: Total sleep time (TST), sleep latency (LPS), sleep wake time (WASO), number of sleep awakenings (NAW) monitored by PSG
timeFrame: Baseline ; for all subjects: Day 1 / Day 2, Day 13 / Day 14; for 1/5 subjects: Day 27 / Day 28
measure: Evaluation of Sleep Structures Recorded by PSG Monitoring
timeFrame: Baseline, for all subjects: Day 1, Day 14; for 1/5 subjects: Day 28
measure: Subjective Total Sleep Time (sTST), Subjective Sleep Latency (sTSO) Recorded by Sleep Diary
timeFrame: Baseline, for all subjects: Week 1,Week 2, for 1/5 subjects:Week 4
measure: Total sleep time (TST), sleep latency (SL), sleep awakening time (WASO), number of sleep awakenings (NAW) and sleep efficiency (SE) recorded by body movement recorder
timeFrame: Baseline, for all subjects:Week 1,Week 2, for 1/5 subjects:Week 4
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline, for all subjects: Day 14, for 1/5 subjects:Day 28
measure: Rebound evaluation and proportion of rebound patients
timeFrame: Follow-up Period, 7 days after double-blind treatment.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing HuiLongGuan Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Changsha
country: China
facility: Hunan Brain Hospital
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Chongqing
country: China
facility: Army Specialty Medical Center
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University (Department of Psychiatry)
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University (Sleep Medicine Center)
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
city: Hefei
country: China
facility: The Second Affiliated Hospital of Anhui Medical University
city: Jiujiang
country: China
facility: The Affiliated Hospital of Jiujiang University
city: Kunming
country: China
facility: The First Affiliated Hospital of Kunming Medical University
city: Kunming
country: China
facility: The First People's Hospital of Yunnan Province
city: Nanchang
country: China
facility: Jiangxi Provincial Psychiatric Hospital
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing
city: Nantong
country: China
facility: The First People 's Hospital of Nantong
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
city: Quanzhou
country: China
facility: The Second Affiliated Hospital of Fujian Medical University
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
city: Shijiazhuang
country: China
facility: The Third Hospital of Hebei Medical University
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
city: Tianjin
country: China
facility: Tianjin Anding Hospital
city: Wuhan
country: China
facility: Wuhan Mental Health Center
city: Xi'an
country: China
facility: Tangdu Hospital, Fourth Military Medical University, PLA
city: Xinxiang
country: China
facility: The Second Affiliated Hospital of Xinxiang Medical University
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
city: Zunyi
country: China
facility: The Affiliated Hospital of Zunyi Medical College
Study officials:
References: