A Study of HS-10506 in Chinese Patients With Insomnia Disorder
ConditionInsomnia Disorder
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-64
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
participants must be 18 to 65 years of age (inclusive 18, not inclusive 65);
participants are required to voluntarily sign the informed consent form;
Body mass index (BMI): BMI (weight/height2 [kg/m2]) must be in the range of 18 to 35 kg/m2 (inclusive);
Participants must meet Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria for insomnia disorder;
Disqualifiers
Has history of/current sleep-wake disorders or sleep-related breathing disorders other than insomnia disorder, such as restless legs syndrome, periodic limb movement disorder, circadian rhythm disorder, narcolepsy, rapid eye movement sleep phase (REM) behavioral disorders, and obstructive sleep apnea;
Has a Apnea-Hypopnea Index (AHI) ≥ 10 times/hour or periodic leg movement with arousal index (PLMAI) ≥ 10 times/hour monitored by PSG at V2 visit;
Has history of/current neurodevelopmental retardation, cognitive impairment, epilepsy, schizophrenia, bipolar disorder, hyperthyroidism, cancer, severe cardio-cerebrovascular diseases or respiratory diseases; or current chronic pain that affects sleep, nocturia resulting in frequent need to get out of bed to use the bathroom during the night; or clinically significant and/or unstable neurological, psychiatric, respiratory, cardiovascular, digestive, immunologic, urologic, endocrine diseases within the past 3 months prior to screening; or other systemic diseases that are inappropriate for the study;
Has a Hamilton Anxiety Scale (HAM-A) score ≥ 14 or Hamilton Depression Scale (HAM-D-17) score ≥ 18;
Trial design
Design model
Parallel
Treatments tested in this trial
HS-10506
DrugHS-10506 tablet
Placebo
DrugPlacebo tablet matched to HS-10506
Treatment groups
732 Participants
are divided into 2 treatment groupsGroup A: HS-10506Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
Baseline, Night 27 and Night 28,Night 83 and Night 842
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
Time frame
Baseline, Night 27 and Night 28, Night 83 and Night 84Secondary outcomes
1
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
Time frame
Baseline, Week 4, Week 122
Change from baseline in subjective sleep efficiency (sSE) under the treatment of 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.
Time frame
Baseline, Week 4, Week 123
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
Time frame
Baseline, Night 27 and Night 28, Night 83 and Night 844
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
Time frame
Baseline, Night 27 and Night 28, Night 83 and Night 84Locations
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Source ClinicalTrials.gov
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