Efficacy and Safety of ACT-541468 in Elderly Subjects With Insomnia Disorder

Completed · Phase 2 · Has a placebo group

Conditions studied: Insomnia Disorder

In brief

This study evaluates the dose response of ACT-541468 on the change of wake after sleep onset (WASO) assessed by polysomnography (PSG) on the first 2 days of each treatment period.

Key facts

Study ID

NCT02841709

Run by

Idorsia Pharmaceuticals Ltd.

People needed

58

Starts

2016-11-28

Expected to finish

2017-06-29

Last updated by the study team

2020-04-24

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent prior to any study-mandated procedure.
• Male or female aged ≥ 65 years.
• Body mass index (BMI): 18.5 ≤ BMI (kg/m2 ) < 32.0
• Insomnia disorder according to DSM-5 criteria.
• Self-reported history of insufficient sleep quantity.
• Insufficient sleep quantity as collected subjectively in the sleep diary and validated objectively by polysomnography.
• Insomnia Severity Index score ≥ 15.

You may not qualify if…

• 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 bilirubin > 1.5 × ULN (except known history of Gilbert's syndrome);
• 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.

Where it is running

• Investigator Site — Brandon, Florida, United States
• Investigator Site — Chicago, Illinois, United States
• Investigator Site — Las Vegas, Nevada, United States
• Investigator Site — New York, New York, United States
• Investigator Site — Cincinnati, Ohio, United States
• Investigator Site — Berlin, Germany
• Investigator Site — Berlin, Germany
• Investigator Site — Hamburg, Germany
• Investigator Site — Hanover, Germany
• Investigator Site — Schwerin, Germany

Full record on ClinicalTrials.gov

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