Insomnia Disorder
Conditions
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.
Interventions
DRUGDaridorexant
Daridorexant will be taken orally, once daily in the evening as indicated by investigator.
DRUGPlacebo
Placebo will be taken orally, once daily in the evening as indicated by investigator.
Sponsors
Nxera Pharma Korea Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective total sleep time(sTST) | Week 4 | Change from baseline to week 4 in subjective total sleep time (sTST) measured by eDairy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Contacts
STUDY_DIRECTORClinical Development, Nxera Pharma Korea Co., Ltd.
Nxera Pharma Korea Co., Ltd.
Outcome results
None listed