Insomnia disorder
Conditions
Interventions
investigational material(s)
Generic name etc : ACT-541468
INN of investigational material : Daridorexant
Therapeutic category code : 119 Other agents affecting central nervous system
Dosage and Admini
Sponsors
Idorsia Pharmaceuticals Japan Ltd.
MOCHIDA PHARMACEUTICAL CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients who consent to participate in the study by signing an ICF (2)Males and females aged 18 and above (at the time of consent) (3)Insomnia disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. (4)Insomnia Severity Index (ISI) score >=15 (5)Usual bedtime between 21:30 and 00:30 (6)Regular time in bed between 6 hours and 9 hours (7)For women of childbearing potential, negative urine pregnancy test, patients with no desire nor plan to become pregnant during the scheduled period of participation in this study, non-lactating patients, patients who agree to use appropriate contraceptive methods as defined by the study protocol from screening until 30 days after the last dose of study drug. (8)Judged by the investigator to be capable of communicating well with the investigator and understanding the requirements of the study
Exclusion criteria
Exclusion criteria: (1)BMI >= 30.0 kg/m^2 (2)History or complications of sleep-related breathing disorder (including chronic obstructive pulmonary disease, sleep apnea) (3)Periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, REM behavior disorder, or narcolepsy. (4)Received cognitive behavioral therapy (CBT) as treatment for insomnia disorder within 4 weeks. Or patients scheduled to undergo CBT during the study period (5)Self-reported usual daytime napping >= 1 hour per day, and >= 3 days per week (6)Acute or unstable psychiatric conditions. (7)Mini Mental State Examination (MMSE) score = 50 years (8)Night shift work within 2 weeks or those who has night shift work in normal work (9)Traveling abroad with a time difference of 4 hours or more within 2 weeks or those traveling abroad with a time difference of 4 hours or more is planned during the study (10)Unstable medical condition, significant medical disorder or acute illness, ECG, hematology or biochemistry test results within 4 weeks, which, in opinion of the investigator, could affect the subject's safety or interfere with the study assessments. (11)Treatment with CNS active drugs within two weeks. However, oral antidepressants, anxiolytics, or antipsychotics (not including those intended for insomnia treatment) used to treat comorbidities that have not changed the dosage or administration for at least 12 weeks is excluded. (12)Diagnosis of alcohol or substance dependence disorder within 2 years prior to Visit 1 or inability to refrain from drinking alcohol for at least 3 consecutive days. (13)Inability to refrain from smoking during the night (14)Participated in other study, including ACT-541468 study within 12 weeks, and/or received other study drug within 12 weeks (15)Known hypersensitivity or contraindication to drug of the same class as the study treatment or any excipients of the study drug formulation (16)Judged to have suicidal ideation. (17)Patients with a prolonged QT interval(> 450 ms). (18)Positive urine drug test (benzodiazepines, barbiturates, cannabinoids, opiates, amphetamine, or cocaine) or a positive breath test for alcohol. (19)AST and/or ALT > 2 x ULN and/or direct bilirubin > 1.5 x ULN. (20)Moderate or severe hepatic impairment (classified as Child-Pugh B and C, or with hepatic impairment equivalent to levels of this class) (21)Severe renal impairment, estimated creatinine clearance < 30 mL/min/1.73 m^2 (22)Hematology or biochemistry test results deviating from the normal range to a clinically relevant extent as per judgment of the investigator. (23)Treatment with moderate or strong CYP3A4 inhibitors or inducers within 1 week. Except for topical formulations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Adverse Event Serious Adverse Event Adverse Evnevt leading discontinuation of study drug treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Subjective total sleep time (sTST) Subjective latency to sleep onset (sLSO) Subjective wake after sleep onset (sWASO) | — |
Countries
Japan
Contacts
Public ContactTakayuki Kawashima
Idorsia Pharmaceuticals Japan Ltd
Outcome results
None listed