Insomnia disorder
Conditions
Interventions
investigational material(s)
Generic name etc : ACT-541468 (Daridorexant)
INN of investigational material : -
Therapeutic category code : 119 Other agents affecting central nervous system
Dosage and Ad
Sponsors
Idorsia Pharmaceuticals Japan Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients who have signed a consent form before starting the study procedures (2)Japanese male or female aged 16 == 3 nights per week for >= 3 months before screening 1)sleep onset >= 30 minutes 2)wake time during sleep >= 30 minutes 3)Total sleep time (TST) == 15 (7)Patients with the following sleep parameters on >= 3 nights in the sleep diary recorded at home on 7 consecutive nights in screening period 1)sleep onset >= 30 minutes 2)wake time during sleep >= 30 minutes 3)Total sleep time (TST) == 20 minutes (not = 30 minutes (not < 20 minutes on either of the 2 nights) 3)Mean TST < 420 minutes (11) In the case of women of childbearing potential, patients meeting the following conditions: 1)Negative result from a serum pregnancy test 2)Negative result from a urine pregnancy test 3)Consents to have pregnancy tests until 30 days after the end of study drug administration 4)Agree to use the contraception scheme as required by the protocol from Screening period up to at least 30 days after study drug discontinuation.
Exclusion criteria
Exclusion criteria: (1)Patients observed to have sleep disorder other than insomnia (Sleep apnea syndrome, etc.) or a related history of respiratory disorder, periodic limb movement disorders, restless legs syndrome, circadian rhythm sleep disorder, REM sleep behavior disorder or narcolepsy (2)Patients who self-report usually sleeping during the daytime for >= 1 hour per day on >= 3 days per week (3)Patients who consume >= 600 mg of caffeine per day (4)Patients working a night shift within 2 weeks before the screening visit or who plan to work night shifts during the study period (5)Patients who traveled across >= 3 time zones within 1 week before the screening visit or who plan to travel across >= 3 time zones during the study (6)Patients who are pregnant, plan to become pregnant or are breastfeeding (7)Patients found to have clinically significant deviations from normal levels in hematology or blood biochemistry test results in the opinion of the principal investigator (8)Patients with aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times above the upper limit of normal (ULN) and/or total bilirubin > 2 times above ULN (excluding those with a history of Gilbert's syndrome) (9)Patients in an unstable medical condition within 1 month before V1, or with a significant medical disorder or acute disease, which affects the patient's safety or the evaluation of the study in the opinion of the principal investigator (10)Patients with a systolic blood pressure > 150 mmHg and/or a diastolic blood pressure of > 90 mmHg (11)Patients with a resting pulse rate = 100/minute (V1, V2) (12)Patients whose corrected QT interval (QTcF) meets either of the following conditions 1)QT interval prolonged (QTc > 450 ms): If the first electrocardiogram (ECG) shows QTc > 450 ms, a second ECG will be measured after >= 30 minutes on the same day. If the second ECG shows a value > 450 ms, the patient is ineligible. 2)The patient has a history of risk factors for torsade de pointes (heart failure, hypokalemia, family history of long QT syndrome, etc.). (13)Patients with either of the following conditions related to suicidal tendencies: 1)Patients with deliberate suicidal ideation at screening, regardless of whether planning was present (a response of "yes" to questions 4 or 5 in the Suicide Ideation section of the screening edition of the Columbia Suicide Severity Rating Scale [C-SSRS]) 2)History of suicide attempts (14)Patients with known factors or diseases that may affect compliance with drug administration, conduct of the study or the interpretation of results, such as psychiatric disease, a history of non-compliance with drug regimens or lack of willingness to comply with the requirements of the study (15)Patients administered another investigational study drug within 1 month before screening (16)Patients with hypersensitivity to, or contraindication of, a drug in the same class as the study drug or the excipients of the study drug formulation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Change in WASO measured by PSG from baseline to each time points | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Change in LPS measured by PSG from baseline to each time points Change in sWASO from baseline to each time points Change in sLSO from baseline to each time points | — |
Countries
Japan
Contacts
Public ContactTakayuki Kawashima
Idorsia Pharmaceuticals Japan Ltd
Outcome results
None listed