A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder

Sponsor
Nxera Pharma Korea Co., Ltd.
Study ID
NCT07028697
Phase
PHASE3
Status
Completed

Conditions

  • Insomnia Disorder

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daridorexant — DRUG
    Daridorexant will be taken orally, once daily in the evening as indicated by investigator.
  • Placebo — DRUG
    Placebo will be taken orally, once daily in the evening as indicated by investigator.

Study Details

The purpose of this phase 3 study is to evaluate the efficacy and safety of Daridorexant compared to in participants with insomnia disorder.

Key Dates

Start date
Dec 4, 2024
Status verified
Jan 2026
Primary completion
Sep 23, 2025
Completion
Oct 21, 2025

Study Design

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

Arms

  • Experimental: Daridorexant
  • Placebo Comparator: Placebo

Primary Outcome Measure

Subjective total sleep time(sTST) [ Time Frame: Week 4 ]

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