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Insomnia DisorderPhase 3NCT06010693

A Study of Daridorexant in Chinese Patients With Insomnia Disorder

A Phase 3 study testing Daridorexant in people with Insomnia Disorder, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 33 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 . Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Insomnia Disorder
What is being tested?
Daridorexant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
206 participants
Where
33 sitesChina
Study dates
28 Aug 2023to 10 May 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

China33 sites

  • Xuanwu Hospital of Capital Medical University

    Beijing, Beijing Municipality, 100053

  • Beijing Huilongguan Hospital

    Beijing, Beijing Municipality

  • Peking University Sixth Hospital

    Beijing, Beijing Municipality

  • The First Hospital of Jilin University

    Changchun, Jilin

  • Xiangya Hospital of Central South University

    Changsha, Hunan

  • Chengdu Second People's Hospital

    Chengdu, Chengdu

  • Chongqing Traditional Chinese Medicine Hospital

    Chongqing, Chongqing Municipality

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning

  • Deyang People's Hospital

    Deyang, Sichuan

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

  • Nanfang Hospital

    Guangzhou, Guangdong

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong

  • Hainan General Hospital

    Haikou, Hainan

  • Hangzhou Seventh People's Hospital

    Hangzhou, Zhejiang

  • The Second People's Hospital Of Hefei

    Hefei, Anhui

  • The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)

    Jinan, Shandong

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • Nanjing Brain Hospital

    Nanjing, Jiangsu

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

  • Huashan Hospital Fudan University

    Shanghai, Shanghai Municipality

  • Shanghai Mental Health Center

    Shanghai, Shanghai Municipality

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • The Third Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • The Second Hospital of Suzhou University

    Suzhou, Jiangsu

  • Tai'an Central Hospital

    Tai’an, Shandong

  • The First Hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • The Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • Tianjin Mental Health Center

    Tianjin, Tianjin Municipality

  • Tianjin People's Hospital

    Tianjin, Tianjin Municipality

  • Xianyang Hospital of Yan'an University

    Xianyang, Shanxi

Other trials in China

About this study

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.

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 .

Being tested
Daridorexant, Placebo
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DaridorexantDrug

    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.

  • PlaceboDrug

    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.

Study groups in NCT06010693
Study groupRoleWhat they receive
DaridorexantExperimentalParticipants 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.
Receives: Drug: Daridorexant
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The change from baseline to month 1 in wake after sleep onset (WASO) measured by polysomnography(PSG).

    Measured: Baseline to last 2 night(night 27 and 28)

Secondary outcomes (2)

  1. The change from baseline to the average of the last 7 days of month 1 in subjective total sleep time(sTST) measured by eDiary

    Measured: Baseline to the average of the last 7 days of month 1

  2. The change from baseline to month 1 in latency to persistent sleep (LPS) measured by PSG.

    Measured: Baseline to last 2 night(night 27 and 28)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2023
  2. Study start28 Aug 2023
  3. Primary completion12 Apr 2024
  4. Study completion10 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06010693
Sponsor's protocol ID
SIM0808-301
Status last verified
Aug 2023
First submitted
20 Aug 2023
Last updated
30 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Huang Z, Wang H, Zhang B, Li C, Wang J, Xu L, Xu Q, Chen J, Xiao L, Wang Z, Wang B, Jiang Y, Liu Y, Yuan C, Ma Q, Wu J, Liu X, Huang Y, Cui H, Wang F, Wang Y. Efficacy and safety of daridorexant in Chinese patients with insomnia disorder: a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial. Sleep. 2025 Dec 11;48(12):zsaf170. doi: 10.1093/sleep/zsaf170.

    PubMed 40557879

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Daridorexant in people with Insomnia Disorder, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 33 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06010693, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.

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