Study to assess the efficacy and safety of ACT-541468 in adult subjects suffering from difficulties to sleep
- Conditions
- Insomnia disorderMedDRA version: 20.0Level: PTClassification code 10022437Term: InsomniaSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2016-000826-21-DE
- Lead Sponsor
- Actelion Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 360
- Signed informed consent prior to any study-mandated procedure
- Male or female aged 18-64 years (inclusive)
- Women of childbearing potential must have a negative and urine pregnancy test and use reliable methods of contraception up to 30 days after EOT
- Body mass index (BMI): 18.5 = BMI (kg/m2) < 32.0
- Insomnia disorder according to DSM-5 criteria
- Insufficient sleep quantity as collected subjectively in the sleep diary and validated objectively by
polysomnography.
- Insomnia Severity Index score = 15.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 360
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Any current history of sleep disorder other than insomnia, or any lifetime history of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, or narcolepsy.
- Self-reported usual daytime napping = 1 hour per day, and = 3 days per week.
- Caffeine consumption = 600 mg per day.
- Shift work within 2 weeks prior to the screening visit, or planned shift work during study.
- Travel = 3 time zones within 1 week prior to the screening visit, or planned travel = 3 time zones during study.
- Hematology or biochemistry test results deviating from the normal range to a clinically relevant extent as per judgment of the Investigator.
- AST and/or ALT > 2 × ULN and/or direct bilirubin > 1.5 × ULN
- Severe renal impairment (known or defined as estimated creatinine clearance < 30 mL/min).
- History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to evaluate the dose-response of ACT-541468 on the change of WASO [Wake After Sleep Onset] assessed by Polysomnography [PSG] after treatment on Days 1 and 2;Secondary Objective: The secondary objective of the study is to evaluate the dose response of ACT-541468 on Latency to Persistent Sleep (LPS) on Days 1&2 and Subjective Latency to Sleep Onset (sLSO) and subjective Wake After Sleep Onset (sWASO) at Week 4;Primary end point(s): Change of WASO (Wake After Sleep Onset) from baseline to Days 1 & 2 as determined by<br>Polysomnography (PSG).;Timepoint(s) of evaluation of this end point: From Baseline to Days 1&2
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1- Sleep initiation endpoints including:<br>Change from baseline to Days 1 & 2 in mean LPS (Latency to Persistent Sleep);<br>Change from baseline to Week 4 in mean sLSO (self reported Latency to Sleep Onset)<br>2- Sleep maintenance endpoint:<br>Change from baseline to Week 4 in mean sWASO [self-reported Subjective Wake after Sleep Onset];Timepoint(s) of evaluation of this end point: LPS: from Baseline to Days 1&2;<br>sLSO: from Baseline to Week 4;<br>sWASO: from Baselinee to Week 4.