Clinical Trial

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

Completed Phase 3
View on ClinicalTrials.gov →
Summary
The purpose of this phase 3 study is to evaluate the efficacy and safety of Daridorexant compared to in participants with insomnia disorder.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2025-06-11; most recent amendment 2026-01-19.
Status change: Active, Not Recruiting → Completed 2026-01-19
Status change: Recruiting → Active, Not Recruiting 2025-09-10
Trial Details
NCT Number NCT07028697
Lead Sponsor Nxera Pharma Korea Co., Ltd.
Conditions Insomnia Disorder
Enrollment 164 participants
Start Date 2024-12-04
Primary Completion 2025-09-23 (estimated)
Study Completion 2025-10-21 (estimated)
Updated on ClinicalTrials.gov 2026-01-21