A Study of Daridorexant in Chinese Patients With Insomnia Disorder

NCT06010693 | Completed Phase 3

• 1 other identifier: SIM0808-301
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 33

Brief 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 .

Conditions

Insomnia Disorder

Outcome Measures

Primary Outcomes (1)

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

  Baseline to last 2 night(night 27 and 28)

Secondary Outcomes (2)

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

  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.

  Baseline to last 2 night(night 27 and 28)

Other Outcomes (14)

• Change from baseline to week 1 in the subjective total sleep time (sTST) measured by edairy.

  Baseline to Week 1

• Change from baseline to month 1 in the objective total sleep time (TST) measured by PSG.

  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.

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

Study Arms (2)

Daridorexant

EXPERIMENTAL

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.

Drug: Daridorexant

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Daridorexant DRUG

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.

Daridorexant

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.
• 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).
• 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.
• 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:
• ≥ 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead

Study Sites (33)

The Second People's Hospital Of Hefei

Hefei, Anhui, China

Location

Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Beijing Huilongguan Hospital

Beijing, Beijing Municipality, China

Location

Peking University Sixth Hospital

Beijing, Beijing Municipality, China

Location

Chengdu Second People's Hospital

Chengdu, Chengdu, China

Location

Chongqing Traditional Chinese Medicine Hospital

Chongqing, Chongqing Municipality, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

Nanfang Hospital

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

Location

Hainan General Hospital

Haikou, Hainan, China

Location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Nanjing Brain Hospital

Nanjing, Jiangsu, China

Location

The Second Hospital of Suzhou University

Suzhou, Jiangsu, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

The First Hospital of Jilin University

Changchun, Jilin, China

Location

The Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Location

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

Jinan, Shandong, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location

Tai'an Central Hospital

Tai’an, Shandong, China

Location

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Location

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

Xianyang Hospital of Yan'an University

Xianyang, Shanxi, China

Location

Deyang People's Hospital

Deyang, Sichuan, China

Location

Tianjin Mental Health Center

Tianjin, Tianjin Municipality, China

Location

Tianjin People's Hospital

Tianjin, Tianjin Municipality, China

Location

Hangzhou Seventh People's Hospital

Hangzhou, Zhejiang, China

Location

Related Publications (1)

• 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.

  PMID: 40557879 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

daridorexant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Yuping Wang, Doctor

  Xuanwu Hospital of Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2023
• First Posted: August 24, 2023
• Study Start: August 28, 2023
• Primary Completion: April 12, 2024
• Study Completion: May 10, 2024
• Last Updated: October 30, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (33)