- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06010693
A Study of Daridorexant in Chinese Patients With Insomnia Disorder
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase 3 Clinical Study to Investigate the Efficacy and Safety of 50 mg Daridorexant in Adult and Elderly Chinese Patients With Insomnia Disorder.
The primary purpose of this study is to assess the efficacy and safety of 50 mg daridorexant in adult and elderly chinese patients with insomnia disorder.
Efficacy will be evaluated on objective and subjective sleep parameters .
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Xiaoying Yang
- Phone Number: +8618611125488
- Email: yangxiaoying@simcere.com
Study Locations
-
-
Anhui
-
Hefei, Anhui, China
- Recruiting
- The Second People's Hospital of Hefei
-
Contact:
- Juncang Wu, Doctor
- Email: wujuncang126@126.com
-
-
Beijing
-
Beijing, Beijing, China, 100053
- Recruiting
- Xuanwu Hospital of Capital Medical University
-
Contact:
- Yuping Wang, Doctor
- Email: wangyuping01@sina.com
-
Beijing, Beijing, China
- Recruiting
- Beijing HuiLongGuan Hospital
-
Contact:
- Jingxu Chen, Doctor
- Email: chenjx1110@163.com
-
Beijing, Beijing, China
- Not yet recruiting
- Peking University Sixth Hospital
-
Contact:
- Weihua Zhang, Doctor
- Email: zwh306@163.com
-
-
Chengdu
-
Chengdu, Chengdu, China
- Recruiting
- ChengDu Second People's Hospital
-
Contact:
- Jian Wang, Doctor
- Email: 42523748@qq.com
-
-
Chongqing
-
Chongqing, Chongqing, China
- Not yet recruiting
- Chongqing Traditional Chinese Medicine Hospital
-
Contact:
- Chenyu Li, Doctor
- Email: 479394929@qq.com
-
-
Fujian
-
Fuzhou, Fujian, China
- Not yet recruiting
- The First Affiliated Hospital Of Fujian Medical University
-
Contact:
- Qichang Lin, Doctor
- Email: change4e@126.com
-
-
Guangdong
-
Guangzhou, Guangdong, China
- Recruiting
- Guangdong Provincial People's Hospital
-
Contact:
- Qiong Ou, Doctor
- Email: ouqiong2776@hotmail.com
-
Guangzhou, Guangdong, China
- Not yet recruiting
- The First Affiliated Hospital of Jinan University
-
Contact:
- Jiyang Pan, Doctor
- Email: jiypan@vip.163.com
-
Guangzhou, Guangdong, China
- Recruiting
- Nanfang Hospital
-
Contact:
- Bin Zhang, Doctor
- Email: zhang73bin@hotmail.com
-
-
Hainan
-
Haikou, Hainan, China
- Not yet recruiting
- Hainan General Hospital
-
Contact:
- Tao Chen, Doctor
- Email: ctxwyc@163.com
-
-
Hebei
-
Shijiazhuang, Hebei, China
- Recruiting
- The Third Hospital of Hebei Medical University
-
Contact:
- Hanqiao Wang, Doctor
- Email: wanghanqiao99@126.com
-
Shijiazhuang, Hebei, China
- Recruiting
- The First Hospital Of Hebei Medical University
-
Contact:
- Qingying Ma, Doctor
- Email: 34381445@qq.com
-
-
Henan
-
Luoyang, Henan, China
- Recruiting
- The First Affiliated Hospital of Henan University of Science and Technology
-
Contact:
- Ganqin Du, Doctor
- Email: dgq99@163.com
-
-
Hunan
-
Changsha, Hunan, China
- Recruiting
- Xiangya Hospital of Central South University
-
Contact:
- Lu Shen, Doctor
- Email: 928.1024@163.com
-
-
Jiangsu
-
Nanjing, Jiangsu, China
- Not yet recruiting
- Nanjing Brain Hospital
-
Contact:
- Shiping Xie, Doctor
- Email: xieshiping@njmu.edu.cn
-
Suzhou, Jiangsu, China
- Recruiting
- The Second Hospital of Suzhou University
-
Contact:
- Chunfeng Liu, Doctor
- Email: liucf20@163.com
-
-
Jiangxi
-
Nanchang, Jiangxi, China
- Recruiting
- The Second Affiliated Hospital of Nanchang University
-
Contact:
- Lijun Xu, Doctor
- Email: 18970907115@163.com
-
-
Jilin
-
Changchun, Jilin, China
- Recruiting
- The First Hospital of Jilin University
-
Contact:
- Zan Wang, Doctor
- Email: wangzanprof@163.com
-
-
Liaoning
-
Dalian, Liaoning, China
- Not yet recruiting
- The Second Affiliated Hospital of Dalian Medical University
-
Contact:
- Yongzhong Lin, Doctor
- Email: lin19671024@163.com
-
Shenyang, Liaoning, China
- Not yet recruiting
- Shengjing Hospital of China Medical University
-
Contact:
- Li Xiao, Doctor
- Email: xiaolisy@163.com
-
-
Shandong
-
Jinan, Shandong, China
- Recruiting
- The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
-
Contact:
- Jiyou Tang, Doctor
- Email: tangjiyou@sohu.com
-
Qingdao, Shandong, China
- Not yet recruiting
- The Affiliated Hospital of Qingdao University
-
Contact:
- Yan Jiang, Doctor
- Email: qdfy_ent@163.com
-
Tai'an, Shandong, China
- Recruiting
- Tai'an Central Hospital
-
Contact:
- Yunlin Liu, Doctor
- Email: bb0538@126.com
-
-
Shanghai
-
Shanghai, Shanghai, China
- Recruiting
- Huashan Hospital Fudan University
-
Contact:
- Huan Yu, Doctor
- Email: yuhuan@fudan.edu.cn
-
Shanghai, Shanghai, China
- Recruiting
- Shanghai Mental Health Center
-
Contact:
- Chengmei Yuan, Doctor
- Email: yuanchengmei@yeah.net
-
-
Shanxi
-
Taiyuan, Shanxi, China
- Not yet recruiting
- The Second Hospital of Shanxi Medical University
-
Contact:
- Bei Wang, Doctor
- Email: myemaila@qq.com
-
Taiyuan, Shanxi, China
- Not yet recruiting
- The First Hospital of Shanxi Medical University
-
Contact:
- Xinrong Li, Doctor
- Email: 18635107987@163.com
-
Xianyang, Shanxi, China
- Recruiting
- XianYang Hospital OF Yan'an University
-
Contact:
- Qiaorong Xu, Doctor
- Email: 547454846@qq.com
-
-
Sichuan
-
Deyang, Sichuan, China
- Recruiting
- Deyang People's Hospital
-
Contact:
- Ping Liu, Doctor
- Email: lzp692@163.com
-
-
Tianjin
-
Tianjin, Tianjin, China
- Recruiting
- Tianjin People's Hospital
-
Contact:
- Meiyun Zhang, Doctor
- Email: zmy22202@diyun.com
-
Tianjin, Tianjin, China
- Not yet recruiting
- Tianjin Mental Health Center
-
Contact:
- Xinjun Zhang, Doctor
- Email: zxj300074@163.com
-
-
Zhejiang
-
Hangzhou, Zhejiang, China
- Recruiting
- Hangzhou Seventh People's Hospital
-
Contact:
- Hongjing Mao, Doctor
- Email: 13777861972@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Signed informed consent prior to any study-mandated procedure.
- Male or female aged ≥ 18 years old, ≤75 years old.
Insomnia disorder according to diagnostic and statistical Manual of Mental Disorder, Fifth Edition (DSM-5®) criteria, as follows:
3.1 The predominant complaint is dissatisfaction with sleep quantity or quality, associated with one (or more) of the following symptoms:
- Difficulty initiating sleep
- Difficulty maintaining sleep, characterized by frequent awakenings or problems returning to sleep after awakenings.
- Early-morning awakening with inability to return to sleep. 3.2 The sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning.
3.3 The sleep difficulty occurs despite adequate opportunity for sleep. 3.4 The insomnia is not better explained by another sleep-wake disorder (e.g., narcolepsy, a breathing-related sleep disorder, a circadian rhythm sleep-wake disorder, a parasomnia).
3.5 The insomnia is not attributable to the physiological effects of a substance (e. g., a drug of abuse, a medication) 3.6 Coexisting mental disorders and medical conditions do not adequately explain the predominant complaint of insomnia.
3.7 Self-reported history of all the following on at least 3 nights per week and for at least 3 months prior to Visit 1: 3.7.1 ≥30 min to fall asleep, and 3.7.2 Wake time during sleep ≥ 30 min, and 3.7.3 Subjective Total Sleep Time (sTST)≤6.5 h
- Insomnia Severity Index© score≥15
- Ability to communicate well with the investigator, to understand the study requirements and independently complete the study, as judged by the investigator, to be alert and oriented to person, place, time, and situation.
Meeting all the following sleep parameters on at least 3 nights out of 7 nights on the eDiary completed at home between Visit 3 and Visit 4:
6.1 ≥ 30 min to fall asleep, and 6.2 Wake time during sleep ≥ 30 min, and 6.3 sTST of ≤ 6.5 h
- Usual bedtime between 20:30 and 00:30 as reported on sleep diary completed between Visit 3 and Visit 4.
- Regular time in bed between 6 and 9 h as reported on sleep diary completed between Visit 3 and Visit 4.
Meeting all the following sleep parameters on the 2 PSG nights at Visit 4:
9.1 Mean Latency to Persistent Sleep (LPS) ≥ 20 min (with neither of the two nights < 15 min), and 9.2 Mean Wake After Sleep Onset (WASO) ≥ 30 min (with neither of the two nights < 20 min), and 9.3 Mean Total Sleep Time (TST) < 420 min
For women of childbearing potential, the following are required:
- Negative serum pregnancy test (Visit 1).
- Negative urine pregnancy test (Visit 3, Visit 5).
- Female and male subjects agree to use the contraception scheme as required by the protocol from Screening visit up to at least 30 days after last D B study treatment intake, and have no plans to become pregnant, planned parenthood or sperm/egg donation plans, unless they have been sterilization surgically (with surgery at least 1 month before dosing), or female are postmenopausal (female subjects with natural menopause ≥12 months, ≥ 50 years old, can be considered postmenopausal after exclusion of pregnancy and other disorders that may cause amenorrhea; If age <50 years by follicle stimulating hormone level confirmed).
Exclusion Criteria:
- Chronic obstructive pulmonary disease, or any lifetime history of sleep-related breathing disorderlike sleep apnea.
- Cognitive behavioral therapy (CBT) for any indication is allowed only if the CBT started at least 1 month prior to Visit 4 and the subject agrees to continue this CBT throughout the study.
- Self-reported usual daytime napping ≥ 1 h per day, and ≥ 3 days per week.
- Acute or unstable psychiatric conditions (including but not restricted to anxiety disorder, major depression, bipolar disorder, schizophrenia, obsessive compulsive disorder, or depression) that are diagnosed by the Mini International Neuropsychiatric Interview© or that require pharmacological treatment for these disorders. N.B.: subjects with a history of major depressive disorder currently without any symptoms and not requiring treatment are eligible.
- Mini Mental State Examination© score < 25 in subjects ≥ 50 years.
- Shift work within 2 weeks prior to the screening visit, or planned shift work during the study.
- Travel across ≥ 3 time zones within 2 weeks prior to the screening visit, or planned travel across ≥ 3 time zones during the study.
- Treatment with central nervous system-active drugs, including over-the- counter medication and herbal medicines, are prohibited by this protocol within 5 half-lives of the respective drug (or 2 weeks, whichever is longer) prior to Visit 1, and until 24 h after the end of treatment (the end of the run-out period).
- Diagnosis of alcohol or substance use disorder within 2 years prior to the screening visit or inability to refrain from drinking alcohol for at least 3 consecutive days.
- Heavy tobacco use (at least one pack of cigarettes a day or inability to refrain from smoking during the night).
- Caffeine consumption ≥ 600 mg per day or any caffeine consumption after 4 pm
- Use of traditional Chinese medicine as prophylaxis or treatment of sleep disturbance within 4 weeks prior to Visit 1 and during the treatment phase.
- Treatment with another investigational drug within 3 months prior to Visit 1, previous treatment with daridorexant or other orexin receptor antagonists (i.e. lemborexant, YZJ-1139) or previous randomization in any trial involving daridorexant
- Known hypersensitivity or contraindication to drugs of the same class as the study treatment or to any excipients of the study drug formulation.
- Not able or willing to stop treatment with moderate or strong cytochrome P450 (CYP)3A4 inhibitors, or treatment with moderate or strong CYP3A4 inducers, within at least 1 week prior to Visit 3, until the end of treatment (the end of the run-out period).
- Not able or willing to stop consumption of grapefruit, Seville (bitter) oranges or juices from those fruits within at least 1 week prior to Visit 3, and until the end of treatment (the end of placebo run-out period).
- A prolonged QTc interval calculated using Fridericia's formula (QTcF) interval (QTcF greater than 450 ms). If the QTcF is greater than 450 ms on the first single 12-lead ECG, 2 additional 12-lead ECGs will be performed (at least after 30 min) and the mean of the 3 QTcF values will be calculated. (QTcF alculation formula seen in 11.5 Appendix)
Periodic limb movement disorder with arousal index (PLMAI)
≥ 15/h (assessed on the 1st PSG night), restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, or narcolepsy.
- Apnea/hypopnea index ≥ 15/h according to American Academy of Sleep Medicine criteria or event associated with blood oxygen saturation level by pulse oximetry (SpO2) < 80%, as assessed on the 1st PSG night
- A history of moderate to severe hepatic impairment (eg, Child-Pugh Class B or C). (details in 11.6 Appendix)
- Sleep diary completed less than 70% between Visit 3 to Visit 4, or at least 3 days out of the 7 days immediately preceding the first PSG of visit 4.
Subjects who took placebo tablets less than 80% of days in from Visit 3 to Visit 4.
Criteria assessed at Visit 1, Visit 2, Visit 3, Visit 4 and Visit 5
Any of the following conditions related to suicidality:
- Any suicidal ideation with intent, with or without a plan, at screening, i.e., answering "Yes" to questions 4 or 5 on the suicidal ideation section of the lifetime (Visit 1) and visit (Visit 2, Visit 3, Visit 4, Visit 5) version of the Columbia Suicide Severity Rating Scale© (C-SSRS©).
- History of suicide attempt on the suicidal behavioral section of the lifetime version of the C-SSRS© (Visit 1).
- Coronavirus Disease 2019 (COVID-19) positive subjects, supported by Antigen test or Nucleic acid detection.
- For female subjects: pregnant, lactating or planning to become pregnant during projected duration of the study.
- Positive urine drug test or presence of alcohol in exhaled breath as detected by breathalyzer test.
- Unstable medical condition, significant medical disorder or acute illness, ECG, hematology or biochemistry test, thyroid function or coagulation test results within 1 month prior to the screening visit, which, in the opinion of the investigator, could affect the subject's safety or interfere with the study assessments.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Daridorexant
Participants will receive one daridorexant 50 mg tablet,orally, once daily for about 28 consecutive night on each night approximately 30 minutes before participants intends to try to sleep.
|
Participants will receive one Daridorexant 50mg tablet, orally, once daily for about 28 consecutive night on each night approximately 30mintues before participants intends to try to sleep.
|
Placebo Comparator: Placebo
Participants will receive one placebo matched to daridorexant 50 mg tablet,orally, once daily for about 28 consecutive night on each night approximately 30 minutes before participants intends to try to sleep.
|
Participants will receive one placebo matched to daridorexant 50 mg tablet , orally, once daily for about 28 consecutive nights on each night approximately 30mintues before participants intends to try to sleep.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The change from baseline to month 1 in wake after sleep onset (WASO) measured by polysomnography(PSG).
Time Frame: Baseline to last 2 night(night 27 and 28)
|
Baseline to last 2 night(night 27 and 28)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The change from baseline to the average of the last 7 days of month 1 in subjective total sleep time(sTST) measured by eDiary
Time Frame: Baseline to the average of the last 7 days of month 1
|
Baseline to the average of the last 7 days of month 1
|
The change from baseline to month 1 in latency to persistent sleep (LPS) measured by PSG.
Time Frame: Baseline to last 2 night(night 27 and 28)
|
Baseline to last 2 night(night 27 and 28)
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline to week 1 in the subjective total sleep time (sTST) measured by edairy.
Time Frame: Baseline to Week 1
|
Baseline to Week 1
|
Change from baseline to month 1 in the objective total sleep time (TST) measured by PSG.
Time Frame: Baseline to last 2 night(night 27 and 28)
|
Baseline to last 2 night(night 27 and 28)
|
Change from baseline to the last 7 days of month 1 in daytime functioning and alertness that is determined by scores on the visual analog scale (VAS ) at the end of the day.
Time Frame: Baseline to the average of the last 7 days of month 1
|
Baseline to the average of the last 7 days of month 1
|
Change from baseline to Month 1 in wake after sleep onset (WASO) over time measured by PSG.
Time Frame: Baseline to last 2 night(night 27 and 28)
|
Baseline to last 2 night(night 27 and 28)
|
Change from baseline to the average of the last 7 nights of Month 1 in the subjective latency to sleep onset (sLSO) measured by eDiary.
Time Frame: Baseline to average of the last 7 days of Month 1
|
Baseline to average of the last 7 days of Month 1
|
The change from baseline to week 1 in subjective latency to sleep onset (sLSO) measured by eDiary.
Time Frame: Base line to Week 1
|
Base line to Week 1
|
Change from baseline to the last 7 nights of month 1 in subjective wake after sleep onset (sWASO) measured by eDiary.
Time Frame: Baseline to average of the last 7 days of month 1
|
Baseline to average of the last 7 days of month 1
|
The change from baseline to week 1 in subjective wake after sleep onset(sWASO) measured by eDiary.
Time Frame: Baseline to Week 1
|
Baseline to Week 1
|
Change from baseline to the last 7 days ofMonth 1/ Week 1 in sleep quality that is determined by scores on the visual analog scale(VAS) in the morning in eDiary.
Time Frame: Baseline to the average of the last 7 days of Month 1/ Week 1
|
Baseline to the average of the last 7 days of Month 1/ Week 1
|
Change from baseline to the last 7 days of Month 1/ Week 1 in depth of sleep that is determined by scores on the VAS (mm) in the morning in eDairy.
Time Frame: Baseline to the average of the last 7 days of Month 1/ Week 1
|
Baseline to the average of the last 7 days of Month 1/ Week 1
|
Change from baseline to the last 7 days of Month 1 / Week 1 in subjective number of awakenings measured by eDiary.
Time Frame: Baseline to the average of the last 7 days of Month 1/ Week 1
|
Baseline to the average of the last 7 days of Month 1/ Week 1
|
Change from baseline to Month 1 in Insomnia Severity Index (ISI) total score. ©) total score
Time Frame: Baseline to month 1
|
Baseline to month 1
|
Change from baseline to Month 1 in sleep efficiency measured by PSG.
Time Frame: Baseline to month 1
|
Baseline to month 1
|
The next-morning plasma concentrations 9-10 hours post dose at the first and second night of Visit 7
Time Frame: Day 27/28 and Day 28/29
|
Day 27/28 and Day 28/29
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yuping Wang, Doctor, Xuanwu Hospital of Capital Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SIM0808-301
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Insomnia Disorder
-
Bod AustraliaWoolcock Institute of Medical ResearchCompletedInsomnia | Sleep Disturbance | Insomnia Type; Sleep Disorder | Insomnia, Transient | Insomnia Due to Anxiety and Fear | Insomnia Due to Other Mental DisorderAustralia
-
Diakonhjemmet HospitalCompletedSleep Disorder | Insomnia | Sleep Initiation and Maintenance Disorders | Sleep Disturbance | Mental Illness | Depression, Anxiety | Insomnia Chronic | Psychological Disorder | Insomnia Due to Mental Disorder | Insomnia, PsychophysiologicalNorway
-
Federal University of Minas GeraisHarvard Medical School (HMS and HSDM)Active, not recruitingDepressive Disorder | Quality of Life | Sleep Disorder | Anxiety Disorders | Insomnia | Spirituality | Stress Disorder | Insomnia Chronic | Insomnia Disorder | Complementary TherapyBrazil
-
Oberwaid AGUniversity of Zurich; University of Basel; Institute for Exercise and Health...CompletedDepression | Sleep Disorder | Insomnia | Sleep Initiation and Maintenance Disorders | Sleep | Sleep Disturbance | Sleep Fragmentation | Insomnia Due to Other Mental Disorder | Insomnia, Psychophysiological | Insomnia Related to Another Mental ConditionSwitzerland
-
National Institute of Mental Health, DhakaSun Pharmaceutical Industries LimitedCompletedMajor Depressive Disorder With InsomniaBangladesh
-
National Taiwan University HospitalNational Science Council, TaiwanUnknownPrimary Insomnia | Depressive Disorders With InsomniaTaiwan
-
University of California, San FranciscoCompleted
-
Laval UniversityCanadian Institutes of Health Research (CIHR)Recruiting
-
University of PennsylvaniaCompletedInsomnia DisorderUnited States
-
Ache Laboratorios Farmaceuticos S.A.Unknown
Clinical Trials on Daridorexant
-
Idorsia Pharmaceuticals Ltd.RecruitingInsomniaSpain, United States, Belgium, Germany, Bulgaria
-
Idorsia Pharmaceuticals Ltd.CompletedInsomnia DisorderUnited States, Germany, Canada, Denmark, Poland, Spain, Switzerland, Belgium, Bulgaria, Finland, France, Hungary, Korea, Republic of, Sweden
-
Idorsia Pharmaceuticals Ltd.Completed
-
Idorsia Pharmaceuticals Ltd.Completed
-
Idorsia Pharmaceuticals Ltd.Completed
-
Idorsia Pharmaceuticals Ltd.CompletedInsomnia DisorderUnited States, Germany, Australia, Canada, Denmark, Italy, Poland, Serbia, Spain, Switzerland
-
Jiangsu Simcere Pharmaceutical Co., Ltd.Completed
-
Idorsia Pharmaceuticals Ltd.Active, not recruitingNocturia | Insomnia DisorderSpain, United States, Germany
-
Idorsia Pharmaceuticals Ltd.CompletedInsomnia DisorderUnited States, Korea, Republic of, Germany, Belgium, Bulgaria, Canada, Czechia, Finland, France, Hungary, Sweden
-
Idorsia Pharmaceuticals Ltd.CompletedObstructive Sleep Apnea of AdultGermany