Clinical trial NCT02841709: Efficacy and Safety of ACT-541468 in Elderly Subjects With Insomnia Disorder
Official title: Multi-center, Double-blind, Randomized, Placebo-controlled, 5-period, 5-treatment Crossover, Polysomnography Dose-response Study to Assess the Efficacy and Safety of ACT-541468 in Elderly Subjects With Insomnia Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Insomnia Disorder
Keywords: insomnia
elderly
Polysomnography
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2016-07-22
Enrollment: 58
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The study consists of 3 phases: a screening phase, a double-blind treatment phase consisting of 5 periods, and a safety follow-up phase. Safety is monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2
timeFrame: Baseline to Day 1 and Day 2 of each treatment period
Secondary outcomes:
measure: Change in Mean Latency to Persistent Sleep (LPS) From Baseline to Days 1 and 2
timeFrame: Baseline to Day 1 and Day 2 of each treatment period
Other outcomes:
Locations:
city: Brandon
country: United States
facility: Investigator Site
state: Florida
city: Chicago
country: United States
facility: Investigator Site
state: Illinois
city: Las Vegas
country: United States
facility: Investigator Site
state: Nevada
city: New York
country: United States
facility: Investigator Site
state: New York
city: Cincinnati
country: United States
facility: Investigator Site
state: Ohio
city: Berlin
country: Germany
facility: Investigator Site
city: Berlin
country: Germany
facility: Investigator Site
city: Hamburg
country: Germany
facility: Investigator Site
city: Hannover
country: Germany
facility: Investigator Site
city: Schwerin
country: Germany
facility: Investigator Site
Study officials:
affiliation: Idorsia Pharmaceuticals Ltd.
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Zammit G, Dauvilliers Y, Pain S, Sebok Kinter D, Mansour Y, Kunz D. Daridorexant, a new dual orexin receptor antagonist, in elderly subjects with insomnia disorder. Neurology. 2020 May 26;94(21):e2222-e2232. doi: 10.1212/WNL.0000000000009475. Epub 2020 Apr 27.