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
Qualifiers
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
Treatments tested in this trial
- HS-10506
- Placebo
Treatment groups
732 Participants
are divided into 2 treatment groupsLocations
This trial has no locations
Sponsors and collaborators
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Lead sponsor
Source ClinicalTrials.gov