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

NCT07028697 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2026-01-21

No results posted yet for this study

Summary

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

Conditions

  • Insomnia Disorder

Interventions

DRUG

Daridorexant

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Nxera Pharma Korea Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Clinical Development, Nxera Pharma Korea Co., Ltd. · Nxera Pharma Korea Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-04
Primary Completion
2025-09-23
Completion
2025-10-21

Countries

  • South Korea

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07028697 on ClinicalTrials.gov