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

Phase 3

Recruiting

• Conditions: Insomnia Disorder
• Interventions: Drug: Daridorexant; Drug: Placebo

• Registration Number: NCT07028697
• Lead Sponsor: Nxera Pharma Korea Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-04
• Status Verified: 2025-06
• Study First Submitted: 2025-06-11
• Study First Submitted QC: 2025-06-11
• Last Update Submitted: 2025-06-18
• Study First Posted: 2025-06-19
• Last Update Posted: 2025-06-24
• Primary Completion: 2025-10
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Signed informed consent prior to any study-mandated procedure;
• Male or female aged ≥ 19 years;
• Insomnia disorder according to DSM-5 criteria;
• 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.
• Insomnia Severity Index score ≥ 15;
• Insufficient sleep quantity as collected subjectively in the sleep diary A. ≥ 30 min to fall asleep, and B. Wake time during sleep ≥ 30 min, and C. Subjective Total Sleep Time (sTST) ≤ 6.5 h

Exclusion Criteria

• Body mass index (BMI) ≥ 40.0 kg/m2
• Documented medical history and/or comorbidity of sleep-related breathing disorder
• History of and/or concurrent sleep apnea or suspected sleep apnea
• Korean-Mini Mental State Examination-2 (K-MMSE-2) score < 25 in subjects ≥ 50 years;
• For female subjects: pregnant, lactating or childbearing potential who do not consent to true abstinence or use an effective method of contraception for required period
• Initiation of the cognitive behavior therapy (CBT) for treatment of insomnia disorder within 4 weeks prior to the Screening visit (Visit 1) or planned CBT during the study
• A history of moderate to severe hepatic impairment (eg, Child-Pugh Class B or C)
• Positive urine drug test or presence of alcohol in exhaled breath as detected by breathalyzer test.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Daridorexant	Daridorexant	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Subjective total sleep time(sTST)	Week 4	Change from baseline to week 4 in subjective total sleep time (sTST) measured by eDairy

Secondary Outcome Measures

Name	Time	Method
Subjective latency to sleep onset (sLSO)	Week 4	Change from baseline to week 4 in subjective latency to sleep onset (sLSO) measured by eDairy
Subjective wake after sleep onset (WASO)	Week 4	Change from baseline to week 4 in subjective wake after sleep onset (WASO) measured by eDairy

Trial Locations

Locations (17)

Inje University Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Pusan National University Yangsan Hospital; 🇰🇷 Busan, Korea, Republic of

Soon Shun Hyang University Cheonan Hospital; 🇰🇷 Cheonan, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of

Inje University Ilsan Paik Hospital; 🇰🇷 Ilsan, Korea, Republic of

Gachon University Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of

Catholic Kwandong University International St. Mary'S Hospital; 🇰🇷 Incheon, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Kyung Hee University Hospital At Gangdong; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Ewha Womans University Medical Center; 🇰🇷 Seoul, Korea, Republic of

The Catholic University of Korea, ST. Vincent's Hospital; 🇰🇷 Suwon, Korea, Republic of

Wonju Severance Christian Hospital; 🇰🇷 Wonju, Korea, Republic of