Safety and Efficacy Study of YZJ-1139 in Primary Chronic Insomnia Disorder

NCT06680505 | Completed Phase 2

• 1 other identifier: YZJ-1139-2-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 33

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

Conditions

Insomnia Disorder

Outcome Measures

Primary Outcomes (1)

• Sleep efficiency (SE) monitored by PSG

  SE is the percentage of the subject 's total sleep time versus the monitored time；Changes from baseline (mean of any consecutive 2 days from Day -7 to Day -1) were evaluated separately for all subjects on Day 1 / Day 2, Day 13 / Day 14 of dosing, and for 1/5 subjects in each group on Day 27 / Day 28 of dosing.

  Baseline , for all subjects: Day 1 / Day 2,Day 13 / Day 14; for 1/5 subjects: Day 27 / Day 28

Secondary Outcomes (6)

• Total sleep time (TST), sleep latency (LPS), sleep wake time (WASO), number of sleep awakenings (NAW) monitored by PSG

  Baseline ; for all subjects: Day 1 / Day 2, Day 13 / Day 14; for 1/5 subjects: Day 27 / Day 28

• Evaluation of Sleep Structures Recorded by PSG Monitoring

  Baseline, for all subjects: Day 1, Day 14; for 1/5 subjects: Day 28

• Subjective Total Sleep Time (sTST), Subjective Sleep Latency (sTSO) Recorded by Sleep Diary

  Baseline, for all subjects: Week 1,Week 2, for 1/5 subjects:Week 4

• 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

  Baseline, for all subjects:Week 1,Week 2, for 1/5 subjects:Week 4

• Insomnia Severity Index (ISI)

  Baseline, for all subjects: Day 14, for 1/5 subjects:Day 28

Study Arms (5)

YZJ-1139 10mg

EXPERIMENTAL

Drug: YZJ-1139 10mg

YZJ-1139 20mg

EXPERIMENTAL

Drug: YZJ-1139 20mg

YZJ-1139 40mg

EXPERIMENTAL

Drug: YZJ-1139 40mg

YZJ-1139 60mg

EXPERIMENTAL

Drug: YZJ-1139 60mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

YZJ-1139 10mg DRUG

YZJ-1139 10mg tablets

YZJ-1139 10mg

YZJ-1139 20mg DRUG

YZJ-1139 20mg tablets

YZJ-1139 20mg

YZJ-1139 40mg DRUG

YZJ-1139 40mg tablets

YZJ-1139 40mg

YZJ-1139 60mg DRUG

YZJ-1139 60mg tablets

YZJ-1139 60mg

Placebo DRUG

Match placebo tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 18 to \< 65 years.
• Meet the clinical diagnostic criteria for primary chronic insomnia disorder as defined in ICSD-3 criteria.
• 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 ≥ 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.
• \. 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.
• \. 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

You may not qualify if:

• 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).
• Apnea-hypopnea index \[AHI\] and/or periodic limb movement index \[PLMI\] \> 10 times/hour detected by PSG monitoring during the run-in period.
• Patients with severe endocrine diseases, blood diseases, cardiovascular and cerebrovascular diseases, autoimmune diseases, respiratory function impairment and other related diseases.
• Previous history of nervous system disorders such as epilepsy, schizophrenia, bipolar mental disorder, neurodevelopmental retardation, cognitive disorder, narcolepsy, and restless leg syndrome.
• 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.
• History of drug taking or addiction, which is known through questioning.
• 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.
• Special occupants who need to operate machinery during the test period, such as professional drivers, high-altitude operators, etc.
• 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.
• AST and ALT \> 2 × the upper limit of normal (ULN), or Cr \> 1.5 × ULN, or white blood cells \< lower limit of normal.
• Hyperthyroidism or hypothyroidism.
• 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).
• History of drug abuse , or positive urine drug screening (screening and/or baseline) for any indicator.
• Regular daily consumption of excessive tea and coffee drinks.
• Patients who have participated in other drug clinical trials within the past 3 months, or participated in other research trials during this trial.

Sponsors & Collaborators

• Shanghai Haiyan Pharmaceutical Technology Co., Ltd.: lead

Study Sites (33)

Beijing HuiLongGuan Hospital

Beijing, China

Location

Peking University People's Hospital

Beijing, China

Location

Xuanwu Hospital, Capital Medical University

Beijing, China

Location

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

Location

The First Hospital of Jilin University

Changchun, China

Location

Hunan Brain Hospital

Changsha, China

Location

Xiangya Hospital, Central South University

Changsha, China

Location

West China Hospital, Sichuan University

Chengdu, China

Location

Army Specialty Medical Center

Chongqing, China

Location

Guangdong Provincial People's Hospital

Guangzhou, China

Location

Nanfang Hospital of Southern Medical University (Department of Psychiatry)

Guangzhou, China

Location

Nanfang Hospital, Southern Medical University (Sleep Medicine Center)

Guangzhou, China

Location

The First Affiliated Hospital of Jinan University

Guangzhou, China

Location

The Second Affiliated Hospital of Anhui Medical University

Hefei, China

Location

The Affiliated Hospital of Jiujiang University

Jiujiang, China

Location

The First Affiliated Hospital of Kunming Medical University

Kunming, China

Location

The First People's Hospital of Yunnan Province

Kunming, China

Location

Jiangxi Provincial Psychiatric Hospital

Nanchang, China

Location

Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing

Nanjing, China

Location

The First People 's Hospital of Nantong

Nantong, China

Location

Qingdao Municipal Hospital

Qingdao, China

Location

The Second Affiliated Hospital of Fujian Medical University

Quanzhou, China

Location

Huashan Hospital Affiliated to Fudan University

Shanghai, China

Location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

The First Hospital of Hebei Medical University

Shijiazhuang, China

Location

The Third Hospital of Hebei Medical University

Shijiazhuang, China

Location

The Second Affiliated Hospital of Soochow University

Suzhou, China

Location

Tianjin Anding Hospital

Tianjin, China

Location

Wuhan Mental Health Center

Wuhan, China

Location

Tangdu Hospital, Fourth Military Medical University, PLA

Xi'an, China

Location

The Second Affiliated Hospital of Xinxiang Medical University

Xinxiang, China

Location

Henan Provincial People's Hospital

Zhengzhou, China

Location

The Affiliated Hospital of Zunyi Medical College

Zunyi, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 8, 2024
• Study Start: August 4, 2019
• Primary Completion: September 30, 2020
• Study Completion: March 29, 2021
• Last Updated: November 8, 2024

Record last verified: 2024-11

Locations

CN (33)