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

Nxera Pharma Korea Co., Ltd.

Status and phase

Completed

Phase 3

Conditions

Insomnia Disorder

Treatments

Drug: Placebo

Drug: Daridorexant

Study type

Interventional

Funder types

Industry

Identifiers

NPK-DAR-301

Details and patient eligibility

About

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

Enrollment

164 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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.