The primary purpose of this open-label phase Ⅲ study is to evaluate the safety of HS-10506 on the incidence and severity of adverse events (AE), serious adverse events (SAE), adverse events of special interest (AESI) in Chinese adult participants with insomnia disorder.
The study will comprise 4 periods : a Screening Period, a Run-in Period, an Open-Label Treatment Period during which participants will be treated for 4, 24, 36, or 48 consecutive weeks and a minimum 7-day Follow-up Period before an End of Study (EOS) Visit. The total study duration for each participant on this study is 2-13 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
600
HS-10506 tablet
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.
Time frame: From date of signing the informed consent until the date of the end-of-study visit or early withdrawal, assessed up to 13 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.
Time frame: From date of signing the informed consent until the date of the end-of-study visit or early withdrawal, assessed up to 13 months
Incidence and severity of adverse events of special interest (AESI)
An AESI (serious or non-serious) is any medical event specific to the investigational product or clinical trial.
Time frame: From date of signing the informed consent until the date of the end-of-study visit or early withdrawal, assessed up to 13 months
Number of Participants With Clinically Significant Change in hematology
Hematology tests will include hemoglobin, hematocrit, red blood cell count, platelets, white blood cell count, count and absolute lymphocytes, neutrophils, basophils, eosinophils, monocytes. Any clinically significant change in hematological values will be determined at the investigator's discretion
Time frame: Baseline, Week 12, Week 24, Week 36, Week 48
Number of Participants With Clinically Significant Change in clinical chemistry
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Clinical chemistry tests will include total and direct bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, albumin, total protein, creatinine, glucose, hemoglobin A1c (HbA1c), creatinine kinase. Any clinically significant change in clinical chemistry values will be determined at the investigator's discretion.
Time frame: Baseline, Week 12, Week 24, Week 36, Week 48
Number of Participants With Clinically Significant Change in urinalysis
Urinalysis will include glucose, ketones, urine red blood cells, urine white blood cells. Any clinically significant change in urinalysis values will be determined at the investigator's discretion.
Time frame: Baseline, Week 12, Week 24, Week 36, Week 48
Withdrawal symptoms by Physician Withdrawal Checklist (PWC-20)
The 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
Time frame: The day after the last administration and at least 7 days after discontinuation of the medication
Rebound insomnia by subjective sleep onset latency (sSOL) during the follow-up period
Time frame: Baseline, Follow-up Period (7-9 days)
Rebound insomnia by subjective wake after sleep onset (sWASO) during the follow-up period
Time frame: Baseline, Follow-up Period (7-9 days)
Rebound insomnia by subjective total sleep time (sTST) during the follow-up period
Time frame: Baseline, Follow-up Period (7-9 days)
Change from baseline in 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, every 4 weeks during Open-Label Treatment Period (up to 12 months)
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
Time frame: Baseline, every 4 weeks during Open-Label Treatment Period (up to 12 months)
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
Time frame: Baseline, every 4 weeks during Open-Label Treatment Period (up to 12 months)
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
Time frame: Baseline, every 4 weeks during Open-Label Treatment Period (up to 12 months)