Insomnia Sleeplessness
Conditions
Interventions
Daridorexant (25mg and 50 mg) and placebo
Sponsors
Idorsia Pharmaceuticals Ltd
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Signed informed consent in a language understandable to the subject prior to any study-mandated procedure. 2. Male and female subjects aged >= 18 years at Screening (18 subjects must be >= 65 years). 3. Woman of childbearing potential (WoCBP) who has a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 1 pre-dose. She must agree to use consistently and correctly (from Screening, during the entire study, and for at least 5-7 days after last study treatment administration) an acceptable method of contraception with a failure rate of
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to daridorexant, or treatments of the same class, or any of its excipients. 2. History of narcolepsy. 6. Any known factor or disease (e.g., unstable medical condition, significant medical disorder, or acute illness) that might interfere with subject*s safety, study conduct, or interpretation of the results, such as: history of non-compliance with medical regimen; history of hearing impairment, psychiatric disease; or neurological disorder that may impact sleep, motor performance, or cognition, including Parkinson disease, predementia, dementia, other neurodegenerative disorder, and stroke. 16. Shift work within 2 weeks prior to Screening, or planned shift work during the study. 17. Travel across >= 3 time zones within 1 week prior to Screening, or planned travel across >= 3 time zones during the study. 18. Previous (i.e., within 2 weeks prior to first study treatment administration) and ongoing treatment with any prescribed central nervous system (CNS)-active medications, and/or diuretics that would affect nighttime rest, and/or moderate to strong cytochrome P450 (CYP)3A4 inhibitors or inducers. 19. Mini Mental State Examination (MMSE) score = 65 years at Screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacodynamic endpoints | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability endpoints | — |
Countries
Netherlands
Outcome results
None listed