JPRN-jRCT2080224596已完成2 期
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 个研究点目标入组 47 人开始时间: 2019年3月14日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
研究概览
简要总结
ACT-541468 is considered that objectively and subjectively improves insomnia symptoms and can be safely administered in subjects with insomnia disorder.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 16age old 至 <= 64age old（—）
- 性别
- All
入选标准
- •(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
- •1)sleep onset >= 30 minutes
- •2)wake time during sleep >= 30 minutes
- •3)Total sleep time (TST) =< 6.5 hours
- •(8)Patients whose usual time of going to bed reported in the sleep diary recorded at home in induction period is between 21:30 and 00:30
- •(9)Patients whose usual time in bed reported in the sleep diary recorded at home in induction period is between 6 and 9 hours
- •(10)Patients whose sleep parameters under all-night PSG for 2 nights meet all following conditions:
- •1)Mean LPS >= 20 minutes (not < 15 minutes on either of the 2 nights)
- •2)Mean WASO >= 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.
排除标准
- •(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 < 50/minute or >= 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
研究者
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