Clinical trial NCT03575104: Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
Official title: Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Polysomnography Study to Assess the Efficacy and Safety of ACT-541468 in Adult and Elderly Subjects With Insomnia Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Insomnia Disorder
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2018-07-02
Enrollment: 924
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent prior to any study-mandated procedure;
* Male or female aged ≥ 18 years;
* Insomnia disorder according to DSM-5 criteria;
* Insomnia Severity Index score ≥ 15;
* Insufficient sleep quantity as collected subjectively in the sleep diary and validated objectively by polysomnography;
* Women of childbearing potential must have a negative and urine pregnancy test and use the contraception scheme up to at least 30 days after last study treatment intake.

Exclusion Criteria:

* Body mass index below 18.5 or above 40.0 kg/m2;
* Any lifetime history of of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, narcolepsy, or apnea/hypopnea;
* Cognitive behavioral therapy (CBT) only allowed if, the treatment started at least 1 month prior to Visit 3 and the subject agrees to continue this CBT throughout the study;
* Self-reported usual daytime napping ≥ 1 hour per day and ≥ 3 days per week;
* Acute or unstable psychiatric conditions diagnosed by the Mini International Neuropsychiatric Interview;
* Mini Mental State Examination (MMSE) score \< 25 in subjects ≥ 50 years;
* For female subjects: pregnant, lactating or planning to become pregnant during projected duration of the study;
* 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 From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance)
timeFrame: From baseline to Month 1 (i.e. for up to 1 month)
measure: Change From Baseline to Month 3 in Wake After Sleep Onset (WASO)
timeFrame: From baseline to Month 3 (i.e. for up to 3 months)
measure: Change From Baseline to Month 1 in Latency to Persistent Sleep (LPS) (Sleep Onset)
timeFrame: From baseline to Month 1 (i.e. for up to 1 month)
measure: Change From Baseline to Month 3 in Latency to Persistent Sleep (LPS)
timeFrame: From baseline to Month 3 (i.e. for up to 3 months)
Secondary outcomes:
measure: Change From Baseline to Month 1 in the Subjective Total Sleep Time (sTST)
timeFrame: From baseline to Month 1 (i.e. for up to 1 month)
measure: Change From Baseline to Month 3 in the Subjective Total Sleep Time (sTST)
timeFrame: From baseline to Month 3 (i.e. for up to 3 months)
measure: Change From Baseline to Month 1 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Sleepiness Domain Score
timeFrame: From baseline to Month 1 (i.e. for up to 1 month)
measure: Change From Baseline to Month 3 in IDSIQ Sleepiness Domain Score
timeFrame: From baseline to Month 3 (i.e. for up to 3 months)
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Pulmonary Associates, Pa
state: Arizona
city: Tucson
country: United States
facility: Noble Clinical Research
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Center for Clinical Research
state: Arkansas
city: Little Rock
country: United States
facility: Woodland International Research Group
state: Arkansas
city: Cerritos
country: United States
facility: Core Healthcare Group
state: California
city: Riverside
country: United States
facility: Artemis Institute For Clinical Research - Riverside
state: California
city: San Diego
country: United States
facility: Pacific Research Network
state: California
city: San Marcos
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Santa Monica
country: United States
facility: Santa Monica Clinical Trials
state: California
city: Upland
country: United States
facility: Empire Clinical Research
state: California
city: Lafayette
country: United States
facility: Innovative Clinical Research
state: Colorado
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Fleming Island
country: United States
facility: Fleming Island Center for Clinical Research
state: Florida
city: Lincoln
country: United States
facility: Clinical Trials Research
state: Florida
city: Saint Petersburg
country: United States
facility: Clinical Research Group of St. Petersburgh
state: Florida
city: Atlanta
country: United States
facility: Neurotrials Research Incorporated
state: Georgia
city: Macon
country: United States
facility: Sleep Practitioners, LLC
state: Georgia
city: Honolulu
country: United States
facility: Hawaii Pacific Neurosciences
state: Hawaii
city: Nampa
country: United States
facility: Saltzer Clinical Research
state: Idaho
city: Lenexa
country: United States
facility: Rowe Neurology Institute
state: Kansas
city: Glen Burnie
country: United States
facility: Sleep Disorders Center of the Mid-Atlantic
state: Maryland
city: Newton
country: United States
facility: Neurocare Inc.
state: Massachusetts
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: Garden City
country: United States
facility: Garden City Asthma and Sleep Center
state: New York
city: Hickory
country: United States
facility: Research Carolina of Hickory
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Clinical Trials of America - NC, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: CTI Clinical Research II
state: Ohio
city: Dublin
country: United States
facility: Ohio Sleep Medicine Institue
state: Ohio
city: Middleburg Heights
country: United States
facility: Cleveland Sleep Research Center
state: Ohio
city: Wooster
country: United States
facility: Robert V. Sibilia, MD, Inc.
state: Ohio
city: Paoli
country: United States
facility: Brian Abaluck LLC
state: Pennsylvania
city: Cordova
country: United States
facility: Wesley Neurology Clinic Pc (Multiple Sclerosis)
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology, LP
state: Texas
city: DeSoto
country: United States
facility: InSite Clinical Research
state: Texas
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Texas
city: Tomball
country: United States
facility: Dm Clinical Research / Martin Diagnostic Clinic
state: Texas
city: Brugge
country: Belgium
facility: HOSPITAL AZ SINT-JAN_Neurology department
city: Brussels
country: Belgium
facility: Hospital Universitair Zieknhuis Brussel, Pneumology and Sleep Laboratory
city: Gent
country: Belgium
facility: University Hospital Gent, Department of General Internal Medicine and Center of neurophysiological Monitoring
city: Leuven
country: Belgium
facility: Hospital UZ Leuven_ Pneumology Department
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Tokuda Hospital EAD
city: Toronto
country: Canada
facility: Canadian Phase Onward Inc.
state: Ontario
city: Etobicoke
country: Canada
facility: Queensway Sleep Lab Sleep Clinic (MedSleep)- 5359 Dundas Street West, Suite 202, Etobicoke, ON M9B 1B1
city: Kelowna
country: Canada
facility: The Medical Arts Health Research Group
city: Markham
country: Canada
facility: Somni Research Inc.
city: Toronto
country: Canada
facility: Somni Research, Calgary
city: Toronto
country: Canada
facility: CANADIAN PHASE ONWARD INC. (Toronto)
city: Klecany
country: Czechia
facility: Narodni Ustav Dusevniho Zdravi (National Institute of Mental Health)
city: Ostrava-Poruba
country: Czechia
facility: Fakultní nemocnice Ostrava, Spánková laboratoř
city: České Budějovice
country: Czechia
facility: Nemocnice České Budějovice, Centrum pro poruchy spánku a spánkovou medicínu
city: Helsinki
country: Finland
facility: Vitalmed Uniklinikka
city: Kuopio
country: Finland
facility: Oivauni Oy - Kuopio
city: Tampere
country: Finland
facility: Oivauni Oy - Tampere
city: Turku
country: Finland
facility: Unitutkimusyksikkö, Turun Yliopisto
city: Lille
country: France
facility: CHRU De Lille - Hospital Salengro - Neurophysiologie Clinique
city: Montpellier
country: France
facility: Clinique beau soleil - Department Sleep and Neurology
city: Nîmes
country: France
facility: CHU NIMES - Unité de Sommeil
city: Berlin
country: Germany
facility: Advanced Sleep Research GmbH
city: Berlin
country: Germany
facility: Klinische Forschung Berlin-Mitte GmbH
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin Kompetenzzentrum Schlafmedizin
city: Bochum
country: Germany
facility: Synexus Clinical Research GmbH
city: Dresden
country: Germany
facility: Klinische Forschung Dresden GmbH
city: Frankfurt
country: Germany
facility: Synexus Clinical Research GmbH
city: Hannover
country: Germany
facility: Klinische Forschung Hannover Mitte GmbH
city: Klingenmünster
country: Germany
facility: Interdisziplinäre Schlafmedizin, Pfalzklinikum
city: Lübeck
country: Germany
facility: Zentrum für Integrative Psychiatrie (ZiP) Universität zu Lübeck
city: Mannheim
country: Germany
facility: Central Insitute of Mental Health Sleep laboratory Medical Faculty Mannheim/Heidelberg University
city: Regensburg
country: Germany
facility: Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie der Universität am Bezirksklinikum Regensburg
city: Schwerin
country: Germany
facility: SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
city: Budapest
country: Hungary
facility: Magyar Honvédség Egészségügyi Központ, Neurológiai Osztály
city: Szeged
country: Hungary
facility: Somnius Kft. SomnoCenter Szeged
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Daegu
country: Korea, Republic of
facility: 4F Neuroimaging analysis laboratory, 56 Dalseong-ro, Jung-gu
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: 3F, 2nd Building, Psychiatry Outpatient, Family Counseling Room, 42 Jebong-ro, Donggu
city: Seongnam
country: Korea, Republic of
facility: 8F Sleep Lab, 1st Building,82, Gumi-ro 173 Beon-gil, Bundang-gu
city: Seoul
country: Korea, Republic of
facility: 3F Sleep Medicine Center, 101 Daehak-Ro Jongno-Gu
city: Seoul
country: Korea, Republic of
facility: 1st CRC room, 2F, Jejoong building, 50-1 Yonsei-ro,, Seodaemun-gu
city: Seoul
country: Korea, Republic of
facility: B2F, Clinical Trial Center, Konkuk University Medical Center 120-1, Neungdong-ro, Gwangjin-gu
city: Seoul
country: Korea, Republic of
facility: B1F Neurological examination room, 892 Dongnam-ro, Gangdong-gu
city: Suwon
country: Korea, Republic of
facility: 2F Psychiatry Outpatient, 93, Jungbu-daero, Paldal-gu
city: Göteborg
country: Sweden
facility: Göteborgs Universitet, Centrum för sömn och vakenhetsstörningar
city: Stockholm
country: Sweden
facility: SOPHIAHEMMET (Stockholm)
city: Uppsala
country: Sweden
facility: Sömnutredningsmottagningen, smärtcentrum Akademiska sjukhuset
city: Örebro
country: Sweden
facility: Universitetssjukhuset Örebro Neurokliniken, Sömnenheten
Study officials:
affiliation: Idorsia Pharmaceuticals Ltd.
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Hudgens S, Phillips-Beyer A, Newton L, Seboek Kinter D, Benes H. Development and Validation of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). Patient. 2021 Mar;14(2):249-268. doi: 10.1007/s40271-020-00474-z. Epub 2020 Nov 1.
citation: Mignot E, Mayleben D, Fietze I, Leger D, Zammit G, Bassetti CLA, Pain S, Kinter DS, Roth T; investigators. Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo-controlled, phase 3 trials. Lancet Neurol. 2022 Feb;21(2):125-139. doi: 10.1016/S1474-4422(21)00436-1.