Clinical trial NCT02839200: Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder
Official title: Multi-center, Double-blind, Randomized, Placebo-controlled, Active-reference, Parallel-group, Polysomnography Dose-response Study to Assess the Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Insomnia Disorder
Keywords: Insomnia
Polysomnography
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2016-07-20
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the dose response of ACT-541468 on the change of WASO from baseline to Days 1 and 2, assessed by PSG.

Detailed description: This study consists of the following phases: screening phase; double-blind treatment phase; safety follow-up phase. Safety is monitored throughout the study.

Eligibility criteria: Principal inclusion Criteria:

* Signed informed consent prior to any study-mandated procedure.
* Male or female aged 18-64 years (inclusive).
* Women of childbearing potential must have negative pregnancy tests 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.

Principal 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 \> or= 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 (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 and Days 1&2
Secondary outcomes:
measure: Change in Latency to Persistent Sleep (LPS) From Baseline to Days 1 and 2
timeFrame: Baseline and Days 1&2
measure: Change in Subjective Latency to Sleep Onset (sLSO) From Baseline to Week 4
timeFrame: Baseline and Week 4
measure: Change in Subjective Wake After Sleep Onset (sWASO) From Baseline to Week 4
timeFrame: Baseline and Week 4
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Investigator Site
state: California
city: Upland
country: United States
facility: Investigator Site
state: California
city: Brandon
country: United States
facility: Investigator Site
state: Florida
city: Clearwater
country: United States
facility: Investigator Site
state: Florida
city: Coral Gables
country: United States
facility: Investigator Site
state: Florida
city: DeLand
country: United States
facility: Investigator Site
state: Florida
city: Hollywood
country: United States
facility: Investigator Site
state: Florida
city: Miami
country: United States
facility: Investigator Site
state: Florida
city: Atlanta
country: United States
facility: Investigator Site
state: Georgia
city: Chicago
country: United States
facility: Investigator Site
state: Illinois
city: Indianapolis
country: United States
facility: Investigator Site
state: Indiana
city: Novi
country: United States
facility: Investigator Site
state: Michigan
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: Berlin
country: Germany
facility: Investigator Site
city: Dresden
country: Germany
facility: Investigator Site
city: Hamburg
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
city: Schwerin
country: Germany
facility: Investigator Site
city: Budapest
country: Hungary
facility: Investigator Site
city: Szeged
country: Hungary
facility: Investigator Site
city: Törökbálint
country: Hungary
facility: Investigator Site
city: Beer Sheva
country: Israel
facility: Investigator Site
city: Haifa
country: Israel
facility: Investigator Site
city: Barcelona
country: Spain
facility: Investigator Site
city: Barcelona
country: Spain
facility: Investigator Site
city: Madrid
country: Spain
facility: Investigator Site
city: Zaragoza
country: Spain
facility: Investigator Site
city: Göteborg
country: Sweden
facility: Investigator Site
city: Örebro
country: Sweden
facility: Investigator Site
Study officials:
affiliation: Idorsia Pharmaceuticals Ltd.
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Dauvilliers Y, Zammit G, Fietze I, Mayleben D, Seboek Kinter D, Pain S, Hedner J. Daridorexant, a New Dual Orexin Receptor Antagonist to Treat Insomnia Disorder. Ann Neurol. 2020 Mar;87(3):347-356. doi: 10.1002/ana.25680. Epub 2020 Feb 5.