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The primary purpose of this phase 3 study is to evaluate the safety and the efficacy of HS-10506 (change versus placebo) on latency to persistent sleep (LPS) and wakefulness after sleep onset (WASO) measured by polysomnography (PSG) in Chinese adult participants with insomnia disorder.
The study will comprise 4 periods : a Screening Period, a Run-in Period, a Treatment Period during which participants will be treated for 84 nights (3 month) and a minimum 3-day Follow-up Period before an End of Study (EOS) Visit. The total study duration for each participant on this study is 105-113 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-10506 | Experimental | Participants will receive HS-10506 tablets, orally, once nightly for 84 consecutive nights |
|
| Placebo | Placebo Comparator | Participants will receive placebo matched in appearance to HS-10506 tablets, orally, once nightly for 84 consecutive nights |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-10506 | Drug | HS-10506 tablet |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of mean latency to persistent sleep (LPS) over the last 2 nights of 28 days and 84 days under the treatment of HS-10506 | LPS was defined as the time in minutes from lights off to the first epoch of 20 consecutive epochs of non-wakefulness as measured by polysomnography (PSG) | Baseline, Night 27 and Night 28,Night 83 and Night 84 |
| Change from baseline of mean wakefulness after sleep onset (WASO) over the last 2 nights of 28 days and 84 days under the treatment of HS-10506 | WASO was defined as minutes of wake from the onset of persistent sleep until lights on as measured by PSG | Baseline, Night 27 and Night 28, Night 83 and Night 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of subjective sleep onset latency (sSOL) under the treatment of HS-10506 | sSOL: estimated minutes from the time that the participant attempted to sleep until sleep onset as recorded in sleep diary | Baseline, Week 4, Week 12 |
| Change from baseline in subjective sleep efficiency (sSE) under the treatment of HS-10506 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huan Yu Yu Principal Investigator | Contact | 021-54602182 | dr.yuhuan@163.com | |
| Yuping Wang Wang Principal Investigator | Contact | 13501186298 | wangyuping01@sina.cn |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Drug |
Placebo tablet matched to HS-10506 |
|
sSE: the ratio of subjective total sleep time(sTST) to subjective time in bed, sTST: the total sleep time reported by the participant in sleep diary. |
| Baseline, Week 4, Week 12 |
| Change from baseline in total sleep time (TST) over the last 2 nights of 28 days and 84 days under the treatment of HS-10506 | TST was defined as the total sleep time in minutes, the total sleep time is the total amount of stages 1, 2, 3 non rapid eye-movement (NREM) and rapid-eye-movement (REM) sleep time, as measured by PSG | Baseline, Night 27 and Night 28, Night 83 and Night 84 |
| Change from baseline in sleep efficiency (SE) over the last 2 nights of 28 days and 84 days under the treatment of HS-10506 | SE was defined as percentage (%) of time spent in bed asleep, calculated as total sleep time (TST) divided by interval from lights off until lights on as measured by PSG multiplied by 100 | Baseline, Night 27 and Night 28, Night 83 and Night 84 |
| Change from baseline in subjective wake after sleep onset (sWASO) under the treatment of HS-10506 | sWASO: estimated minutes of wake at night from initial sleep onset to the time when the participant stopped trying to sleep as recorded in sleep diary | Week 4, Week 12 |
| Change from baseline in subjective total sleep time (sTST) under the treatment of HS-10506 | sTST: the total sleep time reported by the participant in sleep diary | Baseline, Week 4, Week 12 |
| Incidence and severity of adverse events (AE) | An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | From date of signing the informed consent until the date of the end-of-study visit or early withdrawal, assessed up to 4 months |
| Incidence and severity of serious adverse events (SAE) | An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participants and/or may require medical or surgical intervention to prevent one of the outcomes listed above | From date of signing the informed consent until the date of the end-of-study visit or early withdrawal, assessed up to 4 months |
| Withdrawal symptoms by Physician Withdrawal Checklist (PWC-20) | PWC-20 is a 20-item questionnaire and the score of each item ranges from 0-3 (0=not present, 1=mild, 2=moderate, 3=severe) with higher scores indicating greater severity of withdrawal symptoms | The day after the last administration and at least 3 days after discontinuation of the medication |
| Rebound insomnia by sleep diary during the follow-up period | Rebound insomnia is defined as worsened sleep relative to baseline after study drug treatment was completed, rebound insomnia is assessed using the data collected in sleep diary, including estimated minutes from the time that the participant attempted to sleep until sleep onset as recorded in sleep diary (subjective sleep onset latency, sSOL), estimated minutes of wake at night from initial sleep onset to the time when the participant stopped trying to sleep as recorded in sleep diary (subjective wake after sleep onset, sWASO) and the total sleep time reported by the participant in sleep diary ( subjective total sleep time, sTST) | Baseline, Follow-up Period (3-6 days) |
| D001523 |
| Mental Disorders |