xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06010693</url>
    </required_header>
    <id_info>
      <org_study_id>SIM0808-301</org_study_id>
      <nct_id>NCT06010693</nct_id>
    </id_info>
    <brief_title>A Study of Daridorexant in Chinese Patients With Insomnia Disorder</brief_title>
    <official_title>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.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jiangsu Simcere Pharmaceutical Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Jiangsu Simcere Pharmaceutical Co., Ltd.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary purpose of this study is to assess the efficacy and safety of 50 mg daridorexant&#xD;
        in adult and elderly chinese patients with insomnia disorder.&#xD;
  &#xD;
        Efficacy will be evaluated on objective and subjective sleep parameters .&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2025</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The change from baseline to month 1 in wake after sleep onset (WASO) measured by polysomnography(PSG).</measure>
      <time_frame>Baseline to last 2 night(night 27 and 28)</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>The change from baseline to the average of the last 7 days of month 1 in subjective total sleep time(sTST) measured by eDiary</measure>
      <time_frame>Baseline to the average of the last 7 days of month 1</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change from baseline to month 1 in latency to persistent sleep (LPS) measured by PSG.</measure>
      <time_frame>Baseline to last 2 night(night 27 and 28)</time_frame>
    </secondary_outcome>
    <other_outcome>
      <measure>Change from baseline to week 1 in the subjective total sleep time (sTST) measured by edairy.</measure>
      <time_frame>Baseline to Week 1</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Change from baseline to month 1 in the objective total sleep time (TST) measured by PSG.</measure>
      <time_frame>Baseline to last 2 night(night 27 and 28)</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>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.</measure>
      <time_frame>Baseline to the average of the last 7 days of month 1</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Change from baseline to Month 1 in wake after sleep onset (WASO) over time measured by PSG.</measure>
      <time_frame>Baseline to last 2 night(night 27 and 28)</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>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.</measure>
      <time_frame>Baseline to average of the last 7 days of Month 1</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>The change from baseline to week 1 in subjective latency to sleep onset (sLSO) measured by eDiary.</measure>
      <time_frame>Base line to Week 1</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Change from baseline to the last 7 nights of month 1 in subjective wake after sleep onset (sWASO) measured by eDiary.</measure>
      <time_frame>Baseline to average of the last 7 days of month 1</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>The change from baseline to week 1 in subjective wake after sleep onset(sWASO) measured by eDiary.</measure>
      <time_frame>Baseline to Week 1</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>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.</measure>
      <time_frame>Baseline to the average of the last 7 days of Month 1/ Week 1</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>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.</measure>
      <time_frame>Baseline to the average of the last 7 days of Month 1/ Week 1</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Change from baseline to the last 7 days of Month 1 / Week 1 in subjective number of awakenings measured by eDiary.</measure>
      <time_frame>Baseline to the average of the last 7 days of Month 1/ Week 1</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Change from baseline to Month 1 in Insomnia Severity Index (ISI) total score. ©) total score</measure>
      <time_frame>Baseline to month 1</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Change from baseline to Month 1 in sleep efficiency measured by PSG.</measure>
      <time_frame>Baseline to month 1</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>The next-morning plasma concentrations 9-10 hours post dose at the first and second night of Visit 7</measure>
      <time_frame>Day 27/28 and Day 28/29</time_frame>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Insomnia Disorder</condition>
    <arm_group>
      <arm_group_label>Daridorexant</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Daridorexant</intervention_name>
      <description>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.</description>
      <arm_group_label>Daridorexant</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>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.</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Signed informed consent prior to any study-mandated procedure.&#xD;
  &#xD;
            2. Male or female aged ≥ 18 years old, ≤75 years old.&#xD;
  &#xD;
            3. Insomnia disorder according to diagnostic and statistical Manual of Mental Disorder,&#xD;
               Fifth Edition (DSM-5®) criteria, as follows:&#xD;
  &#xD;
               3.1 The predominant complaint is dissatisfaction with sleep quantity or quality,&#xD;
               associated with one (or more) of the following symptoms:&#xD;
  &#xD;
                 -  Difficulty initiating sleep&#xD;
  &#xD;
                 -  Difficulty maintaining sleep, characterized by frequent awakenings or problems&#xD;
                    returning to sleep after awakenings.&#xD;
  &#xD;
                 -  Early-morning awakening with inability to return to sleep. 3.2 The sleep&#xD;
                    disturbance causes clinically significant distress or impairment in social,&#xD;
                    occupational, educational, academic, behavioral, or other important areas of&#xD;
                    functioning.&#xD;
  &#xD;
               3.3 The sleep difficulty occurs despite adequate opportunity for sleep. 3.4 The&#xD;
               insomnia is not better explained by another sleep-wake disorder (e.g., narcolepsy, a&#xD;
               breathing-related sleep disorder, a circadian rhythm sleep-wake disorder, a&#xD;
               parasomnia).&#xD;
  &#xD;
               3.5 The insomnia is not attributable to the physiological effects of a substance (e.&#xD;
               g., a drug of abuse, a medication) 3.6 Coexisting mental disorders and medical&#xD;
               conditions do not adequately explain the predominant complaint of insomnia.&#xD;
  &#xD;
               3.7 Self-reported history of all the following on at least 3 nights per week and for&#xD;
               at least 3 months prior to Visit 1: 3.7.1 ≥30 min to fall asleep, and 3.7.2 Wake time&#xD;
               during sleep ≥ 30 min, and 3.7.3 Subjective Total Sleep Time (sTST)≤6.5 h&#xD;
  &#xD;
            4. Insomnia Severity Index© score≥15&#xD;
  &#xD;
            5. Ability to communicate well with the investigator, to understand the study&#xD;
               requirements and independently complete the study, as judged by the investigator, to&#xD;
               be alert and oriented to person, place, time, and situation.&#xD;
  &#xD;
            6. Meeting all the following sleep parameters on at least 3 nights out of 7 nights on the&#xD;
               eDiary completed at home between Visit 3 and Visit 4:&#xD;
  &#xD;
               6.1 ≥ 30 min to fall asleep, and 6.2 Wake time during sleep ≥ 30 min, and 6.3 sTST of&#xD;
               ≤ 6.5 h&#xD;
  &#xD;
            7. Usual bedtime between 20:30 and 00:30 as reported on sleep diary completed between&#xD;
               Visit 3 and Visit 4.&#xD;
  &#xD;
            8. Regular time in bed between 6 and 9 h as reported on sleep diary completed between&#xD;
               Visit 3 and Visit 4.&#xD;
  &#xD;
            9. Meeting all the following sleep parameters on the 2 PSG nights at Visit 4:&#xD;
  &#xD;
               9.1 Mean Latency to Persistent Sleep (LPS) ≥ 20 min (with neither of the two nights &lt;&#xD;
               15 min), and 9.2 Mean Wake After Sleep Onset (WASO) ≥ 30 min (with neither of the two&#xD;
               nights &lt; 20 min), and 9.3 Mean Total Sleep Time (TST) &lt; 420 min&#xD;
  &#xD;
           10. For women of childbearing potential, the following are required:&#xD;
  &#xD;
                 -  Negative serum pregnancy test (Visit 1).&#xD;
  &#xD;
                 -  Negative urine pregnancy test (Visit 3, Visit 5).&#xD;
  &#xD;
           11. Female and male subjects agree to use the contraception scheme as required by the&#xD;
               protocol from Screening visit up to at least 30 days after last D B study treatment&#xD;
               intake, and have no plans to become pregnant, planned parenthood or sperm/egg donation&#xD;
               plans, unless they have been sterilization surgically (with surgery at least 1 month&#xD;
               before dosing), or female are postmenopausal (female subjects with natural menopause&#xD;
               ≥12 months, ≥ 50 years old, can be considered postmenopausal after exclusion of&#xD;
               pregnancy and other disorders that may cause amenorrhea; If age &lt;50 years by follicle&#xD;
               stimulating hormone level confirmed).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Chronic obstructive pulmonary disease, or any lifetime history of sleep-related&#xD;
               breathing disorderlike sleep apnea.&#xD;
  &#xD;
            2. Cognitive behavioral therapy (CBT) for any indication is allowed only if the CBT&#xD;
               started at least 1 month prior to Visit 4 and the subject agrees to continue this CBT&#xD;
               throughout the study.&#xD;
  &#xD;
            3. Self-reported usual daytime napping ≥ 1 h per day, and ≥ 3 days per week.&#xD;
  &#xD;
            4. Acute or unstable psychiatric conditions (including but not restricted to anxiety&#xD;
               disorder, major depression, bipolar disorder, schizophrenia, obsessive compulsive&#xD;
               disorder, or depression) that are diagnosed by the Mini International Neuropsychiatric&#xD;
               Interview© or that require pharmacological treatment for these disorders. N.B.:&#xD;
               subjects with a history of major depressive disorder currently without any symptoms&#xD;
               and not requiring treatment are eligible.&#xD;
  &#xD;
            5. Mini Mental State Examination© score &lt; 25 in subjects ≥ 50 years.&#xD;
  &#xD;
            6. Shift work within 2 weeks prior to the screening visit, or planned shift work during&#xD;
               the study.&#xD;
  &#xD;
            7. Travel across ≥ 3 time zones within 2 weeks prior to the screening visit, or planned&#xD;
               travel across ≥ 3 time zones during the study.&#xD;
  &#xD;
            8. Treatment with central nervous system-active drugs, including over-the- counter&#xD;
               medication and herbal medicines, are prohibited by this protocol within 5 half-lives&#xD;
               of the respective drug (or 2 weeks, whichever is longer) prior to Visit 1, and until&#xD;
               24 h after the end of treatment (the end of the run-out period).&#xD;
  &#xD;
            9. Diagnosis of alcohol or substance use disorder within 2 years prior to the screening&#xD;
               visit or inability to refrain from drinking alcohol for at least 3 consecutive days.&#xD;
  &#xD;
           10. Heavy tobacco use (at least one pack of cigarettes a day or inability to refrain from&#xD;
               smoking during the night).&#xD;
  &#xD;
           11. Caffeine consumption ≥ 600 mg per day or any caffeine consumption after 4 pm&#xD;
  &#xD;
           12. Use of traditional Chinese medicine as prophylaxis or treatment of sleep disturbance&#xD;
               within 4 weeks prior to Visit 1 and during the treatment phase.&#xD;
  &#xD;
           13. Treatment with another investigational drug within 3 months prior to Visit 1, previous&#xD;
               treatment with daridorexant or other orexin receptor antagonists (i.e. lemborexant,&#xD;
               YZJ-1139) or previous randomization in any trial involving daridorexant&#xD;
  &#xD;
           14. Known hypersensitivity or contraindication to drugs of the same class as the study&#xD;
               treatment or to any excipients of the study drug formulation.&#xD;
  &#xD;
           15. Not able or willing to stop treatment with moderate or strong cytochrome P450 (CYP)3A4&#xD;
               inhibitors, or treatment with moderate or strong CYP3A4 inducers, within at least 1&#xD;
               week prior to Visit 3, until the end of treatment (the end of the run-out period).&#xD;
  &#xD;
           16. Not able or willing to stop consumption of grapefruit, Seville (bitter) oranges or&#xD;
               juices from those fruits within at least 1 week prior to Visit 3, and until the end of&#xD;
               treatment (the end of placebo run-out period).&#xD;
  &#xD;
           17. A prolonged QTc interval calculated using Fridericia's formula (QTcF) interval (QTcF&#xD;
               greater than 450 ms). If the QTcF is greater than 450 ms on the first single 12-lead&#xD;
               ECG, 2 additional 12-lead ECGs will be performed (at least after 30 min) and the mean&#xD;
               of the 3 QTcF values will be calculated. (QTcF alculation formula seen in 11.5&#xD;
               Appendix)&#xD;
  &#xD;
           18. Periodic limb movement disorder with arousal index (PLMAI)&#xD;
  &#xD;
               ≥ 15/h (assessed on the 1st PSG night), restless legs syndrome, circadian rhythm&#xD;
               disorder, rapid eye movement (REM) behavior disorder, or narcolepsy.&#xD;
  &#xD;
           19. Apnea/hypopnea index ≥ 15/h according to American Academy of Sleep Medicine criteria&#xD;
               or event associated with blood oxygen saturation level by pulse oximetry (SpO2) &lt; 80%,&#xD;
               as assessed on the 1st PSG night&#xD;
  &#xD;
           20. A history of moderate to severe hepatic impairment (eg, Child-Pugh Class B or C).&#xD;
               (details in 11.6 Appendix)&#xD;
  &#xD;
           21. Sleep diary completed less than 70% between Visit 3 to Visit 4, or at least 3 days out&#xD;
               of the 7 days immediately preceding the first PSG of visit 4.&#xD;
  &#xD;
           22. Subjects who took placebo tablets less than 80% of days in from Visit 3 to Visit 4.&#xD;
  &#xD;
               Criteria assessed at Visit 1, Visit 2, Visit 3, Visit 4 and Visit 5&#xD;
  &#xD;
           23. Any of the following conditions related to suicidality:&#xD;
  &#xD;
                 -  Any suicidal ideation with intent, with or without a plan, at screening, i.e.,&#xD;
                    answering &quot;Yes&quot; to questions 4 or 5 on the suicidal ideation section of the&#xD;
                    lifetime (Visit 1) and visit (Visit 2, Visit 3, Visit 4, Visit 5) version of the&#xD;
                    Columbia Suicide Severity Rating Scale© (C-SSRS©).&#xD;
  &#xD;
                 -  History of suicide attempt on the suicidal behavioral section of the lifetime&#xD;
                    version of the C-SSRS© (Visit 1).&#xD;
  &#xD;
           24. Coronavirus Disease 2019 (COVID-19) positive subjects, supported by Antigen test or&#xD;
               Nucleic acid detection.&#xD;
  &#xD;
           25. For female subjects: pregnant, lactating or planning to become pregnant during&#xD;
               projected duration of the study.&#xD;
  &#xD;
           26. Positive urine drug test or presence of alcohol in exhaled breath as detected by&#xD;
               breathalyzer test.&#xD;
  &#xD;
           27. Unstable medical condition, significant medical disorder or acute illness, ECG,&#xD;
               hematology or biochemistry test, thyroid function or coagulation test results within 1&#xD;
               month prior to the screening visit, which, in the opinion of the investigator, could&#xD;
               affect the subject's safety or interfere with the study assessments.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yuping Wang, Doctor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Xuanwu Hospital of Capital Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xiaoying Yang</last_name>
      <phone>+8618611125488</phone>
      <email>yangxiaoying@simcere.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>The Second People's Hospital Of Hefei</name>
        <address>
          <city>Hefei</city>
          <state>Anhui</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Xuanwu Hospital of Capital Medical University</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100053</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yuping Wang, Doctor</last_name>
        <email>wangyuping01@sina.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Beijing Huilongguan Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Jingxu Chen, Doctor</last_name>
        <email>chenjx1110@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Peking University Sixth Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Weihua Zhang, Doctor</last_name>
        <email>zwh306@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Chengdu Second People's Hospital</name>
        <address>
          <city>Chengdu</city>
          <state>Chengdu</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Jian Wang, Doctor</last_name>
        <email>42523748@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Chongqing Traditional Chinese Medicine Hospital</name>
        <address>
          <city>Chongqing</city>
          <state>Chongqing</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Chenyu Li, Doctor</last_name>
        <email>479394929@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Fujian Medical University</name>
        <address>
          <city>Fuzhou</city>
          <state>Fujian</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Qichang Lin, Doctor</last_name>
        <email>change4e@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Guangdong Provincial People's Hospital</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Qiong Ou, Doctor</last_name>
        <email>ouqiong2776@hotmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Nanfang Hospital</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Bin Zhang, Doctor</last_name>
        <email>zhang73bin@hotmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Jinan University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Jiyang Pan, Doctor</last_name>
        <email>jiypan@vip.163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hainan General Hospital</name>
        <address>
          <city>Haikou</city>
          <state>Hainan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Tao Chen, Doctor</last_name>
        <email>ctxwyc@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Hospital of Hebei Medical University</name>
        <address>
          <city>Shijiazhuang</city>
          <state>Hebei</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Qingying Ma, Doctor</last_name>
        <email>34381445@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Third Hospital of Hebei Medical University</name>
        <address>
          <city>Shijiazhuang</city>
          <state>Hebei</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Hanqiao Wang, Doctor</last_name>
        <email>wanghanqiao99@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Henan University of Science and Technology</name>
        <address>
          <city>Luoyang</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Ganqin Du, Doctor</last_name>
        <email>dgq99@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Xiangya Hospital of Central South University</name>
        <address>
          <city>Changsha</city>
          <state>Hunan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Lu Shen, Doctor</last_name>
        <email>928.1024@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Nanjing Brain Hospital</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Shiping Xie, Doctor</last_name>
        <email>xieshiping@njmu.edu.cn</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Second Hospital of Suzhou University</name>
        <address>
          <city>Suzhou</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Chunfeng Liu, Doctor</last_name>
        <email>liucf20@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Second Affiliated Hospital of Nanchang University</name>
        <address>
          <city>Nanchang</city>
          <state>Jiangxi</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Lijun Xu, Doctor</last_name>
        <email>18970907115@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Hospital of Jilin University</name>
        <address>
          <city>Changchun</city>
          <state>Jilin</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Zan Wang, Doctor</last_name>
        <email>wangzanprof@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Second Affiliated Hospital of Dalian Medical University</name>
        <address>
          <city>Dalian</city>
          <state>Liaoning</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yongzhong Lin, Doctor</last_name>
        <email>lin19671024@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shengjing Hospital of China Medical University</name>
        <address>
          <city>Shenyang</city>
          <state>Liaoning</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Li Xiao, Doctor</last_name>
        <email>xiaolisy@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Jiyou Tang, Doctor</last_name>
        <email>tangjiyou@sohu.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Affiliated Hospital of Qingdao University</name>
        <address>
          <city>Qingdao</city>
          <state>Shandong</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yan Jiang, Doctor</last_name>
        <email>qdfy_ent@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Tai'an Central Hospital</name>
        <address>
          <city>Tai'an</city>
          <state>Shandong</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Huashan Hospital Fudan University</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Huan Yu, Doctor</last_name>
        <email>yuhuan@fudan.edu.cn</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shanghai Mental Health Center</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Chengmei Yuan, Doctor</last_name>
        <email>yuanchengmei@yeah.net</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Hospital of Shanxi Medical University</name>
        <address>
          <city>Taiyuan</city>
          <state>Shanxi</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Xinrong Li, Doctor</last_name>
        <email>18635107987@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Second Hospital of Shanxi Medical University</name>
        <address>
          <city>Taiyuan</city>
          <state>Shanxi</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Bei Wang, Doctor</last_name>
        <email>myemaila@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Xianyang Hospital of Yan'an University</name>
        <address>
          <city>Xianyang</city>
          <state>Shanxi</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Qiaorong Xu, Doctor</last_name>
        <email>547454846@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Deyang People's Hospital</name>
        <address>
          <city>Deyang</city>
          <state>Sichuan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Ping Liu, Doctor</last_name>
        <email>lzp692@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Tianjin Mental Health Center</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Xinjun Zhang, Doctor</last_name>
        <email>zxj300074@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Tianjin People's Hospital</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Meiyun Zhang, Doctor</last_name>
        <email>zmy22202@diyun.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hangzhou Seventh People's Hospital</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Hongjing Mao, Doctor</last_name>
        <email>13777861972@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 20, 2023</last_update_submitted>
    <last_update_submitted_qc>August 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06010693
  org study id: SIM0808-301
  nct id: NCT06010693
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  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 .
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: 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)
  measure: 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
  measure: 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)
  measure: Change from baseline to week 1 in the subjective total sleep time (sTST) measured by edairy.
  time frame: Baseline to Week 1
  measure: 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)
  measure: 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
  measure: 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)
  measure: 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
  measure: The change from baseline to week 1 in subjective latency to sleep onset (sLSO) measured by eDiary.
  time frame: Base line to Week 1
  measure: 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
  measure: The change from baseline to week 1 in subjective wake after sleep onset(sWASO) measured by eDiary.
  time frame: Baseline to Week 1
  measure: 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
  measure: 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
  measure: 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
  measure: Change from baseline to Month 1 in Insomnia Severity Index (ISI) total score. ©) total score
  time frame: Baseline to month 1
  measure: Change from baseline to Month 1 in sleep efficiency measured by PSG.
  time frame: Baseline to month 1
  measure: 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
  arm group label: Daridorexant
  arm group type: Experimental
  description: 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.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: 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.
  intervention type: Drug
  intervention name: Daridorexant
  description: 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.
  arm group label: Daridorexant
  intervention type: Drug
  intervention name: Placebo
  description: 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.
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Yuping Wang, Doctor
  role: Principal Investigator
  affiliation: Xuanwu Hospital of Capital Medical University
  last name: Xiaoying Yang
  phone: +8618611125488
  email: yangxiaoying@simcere.com
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  country: China
  responsible party type: Sponsor
  mesh term: Sleep Initiation and Maintenance Disorders
  sharing ipd: No