A Study of Daridorexant in Chinese Patients With Insomnia Disorder

Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
Study ID
NCT06010693
Phase
PHASE3
Status
Completed

Conditions

  • Insomnia Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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 .

Key Dates

Start date
Aug 28, 2023
Status verified
Aug 2023
Primary completion
Apr 12, 2024
Completion
May 10, 2024

Study Design

Enrollment
206 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

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) ]

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