A multicenter, double-blind, randomized, placebo-controlled, 4-period, 4-treatment crossover polysomnography study to investigate the efficacy and safety of ACT-541468 in Japanese patients with insomnia disorder

Idorsia Pharmaceuticals Japan Ltd0 sites47 target enrollmentMarch 14, 2019

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: Idorsia Pharmaceuticals Japan Ltd
Enrollment: 47
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

ACT-541468 is considered that objectively and subjectively improves insomnia symptoms and can be safely administered in subjects with insomnia disorder.

Registry

who.int

Start Date

March 14, 2019

End Date

June 30, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Idorsia Pharmaceuticals Japan Ltd

Eligibility Criteria

Inclusion Criteria

•(1\)Patients who have signed a consent form before starting the study procedures
•(2\)Japanese male or female aged 16 \=\<, \<65 years
•(3\)Body mass index (BMI): 18\.5 \=\< BMI (kg/m2\) \< 32\.0
•(4\)Insomnia based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders (5th Edition)
•(5\)Patients self\-reporting all the followings for \>\= 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) \=\< 6\.5 hours
•(6\)Patients with an Insomnia Severity Index (ISI) score \>\= 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

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