Safety and Efficacy Study of YZJ-1139 Tablets in Insomnia Disorder (NCT06975514) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy Study of YZJ-1139 Tablets in Insomnia Disorder
China61 participantsStarted 2025-03-25
Plain-language summary
The main purpose of this study is to assess efficacy of YZJ-1139 for 28 days in adult subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males and females, aged ≥ 18 to \< 65 years.
. Meet the clinical diagnostic criteria for insomnia disorder as defined in ICSD-3 criteria.
. sTSO ≥ 30 min for at least 3 nights per week and/or sWASO ≥ 60 min for at least 3 nights per week within 4 weeks prior to screening.
. Able to recognize 26 English letters and MMSE score indicats no cognitive impairment.
. During the run-in period and 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 PSG monitoring.
. PSG results for 2 consecutive nights during the run-in period should meet the following conditions:
. The mean LPS ≥ 30 min for 2 nights and ≥ 20 min for any one night; And/or the mean WASO ≥ 60 min for 2 nights, and ≥ 45 min either night.
. The mean SE ≤ 85% for 2nights, with the SE ≤ 87.5% for both nights .
Exclusion criteria
. Hypersensitivity to YZJ-1139 tablets or zolpidem or to their excipients.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline of Mean Objective Wake After Sleep Onset (WASO)
Timeframe: Baseline, Day 1/Day 2, Day 27/Day 28
2
Change from baseline of Mean Objective Sleep Efficiency (SE)
Timeframe: Baseline, Day 1/Day 2, Day 27/Day 28
3
Change from baseline of Mean Objective Total Sleep Time (TST)
Timeframe: Baseline, Day 1/Day 2, Day 27/Day 28
4
Change from baseline of Mean Objective Latency to Persistent Sleep (LPS)
. 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.
. 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).
. Current or previous history of psychiatric or neurological disease 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.
. Previous history of sleep-related respiratory disorders including obstructive sleep apnea (with or without continuous positive airway pressure \[CPAP\] therapy), periodic limb movement disorder, myasthenia gravis, 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. Those who have been cured of the above diseases can be enrolled.
. Have previous complex sleep behaviors, such as sleep driving, sleep eating, and sleep phone calls.
. Have nocturia increased caused by urinary tract infection, urinary tract injury or prostatic disorder.