Clinical trial NCT03545191: Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder
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: 2018-06-04
Enrollment: 930
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;
* 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: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Birmingham
country: United States
facility: Pulmonary Associates of the Southeast/WCR
state: Alabama
city: Little Rock
country: United States
facility: Preferred Research Partners, Inc
state: Arkansas
city: Rogers
country: United States
facility: Woodland Research Northwest
state: Arkansas
city: Huntington Beach
country: United States
facility: Marvel Clinical Research
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trials
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Brandon
country: United States
facility: PAB Clinical Research
state: Florida
city: Clearwater
country: United States
facility: St. Francis Sleep Allergy and Lung Institute
state: Florida
city: Hialeah
country: United States
facility: Innovative Clinical Research, Inc.
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America
state: Florida
city: Lake Worth
country: United States
facility: Canvas Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: BioMed Research Institute
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners, LLC
state: Florida
city: Michigan City
country: United States
facility: LaPorte County Institute for Clinical Research
state: Indiana
city: Louisville
country: United States
facility: Kentucky Research Group
state: Kentucky
city: Chevy Chase
country: United States
facility: Helene Emsellem, MD
state: Maryland
city: North Dartmouth
country: United States
facility: Infinity Medical Research, Inc.
state: Massachusetts
city: La Vista
country: United States
facility: Barrett Clinic
state: Nebraska
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: New York
country: United States
facility: Clinilabs NYC
state: New York
city: Huntersville
country: United States
facility: Research Carolina of Huntersville
state: North Carolina
city: New Bern
country: United States
facility: Coastal Carolina Healthcare
state: North Carolina
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Salem
country: United States
facility: Oregon Center for Clinical Investigations,Inc
state: Oregon
city: Lincoln
country: United States
facility: BTC of Lincoln
state: Rhode Island
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Columbia
country: United States
facility: Bogan Sleep Consulting, LLC
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Johnson City
country: United States
facility: Tri-State Mountain Neurology
state: Tennessee
city: Baytown
country: United States
facility: Inquest Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Sleep Therapy & Research Center
state: Texas
city: Orem
country: United States
facility: Aspen Clinical Research
state: Utah
city: Richmond
country: United States
facility: Pulmonary Associates of Richmond
state: Virginia
city: Vienna
country: United States
facility: Sleep Disorders Centers of the Mid-Atlantic
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Adelaide
country: Australia
facility: Respiratory Clinical Trials
city: Auchenflower
country: Australia
facility: Genesis Sleep Care Queensland
city: East Melbourne
country: Australia
facility: Melbourne Sleep Disorders Centre
city: Glebe
country: Australia
facility: The Woolcock Institute of Medical Research
city: Parkville
country: Australia
facility: Royal Melbourne Hospital, Department of Respiratory Medicine
city: Southport
country: Australia
facility: Gold Coast University Hospital, Respiratory Medicine and Sleep Services
city: Westmead
country: Australia
facility: Westmead Hospital, Department of Respiratory and Sleep Medicine
city: Mississauga
country: Canada
facility: Tri-Hospital Sleep Laboratory West
city: Quebec
country: Canada
facility: CRIUSMQ- CIUSSSCN, CETS (clinique du sommeil)
city: Toronto
country: Canada
facility: MedSleep
city: Toronto
country: Canada
facility: Jodha Tishon Inc.
city: København
country: Denmark
facility: Scan Sleep Specialists
city: Berlin
country: Germany
facility: St Hedwig-Krankenhaus, Klinik für Schlaf- und Chronomedizin
city: Berlin
country: Germany
facility: emovis GmbH
city: Berlin
country: Germany
facility: Synexus Berlin Research Centre
city: Hamburg
country: Germany
facility: Clinical Trial Center North GmbH & Co. KG
city: Hamburg
country: Germany
facility: Klinische Forschung Hamburg GmbH
city: Karlsruhe
country: Germany
facility: Klinische Forschung Karlsruhe GmbH
city: Kassel
country: Germany
facility: Studienzentrum Wilhelmshöhe GmbH
city: Leipzig
country: Germany
facility: Synexus Leipzig Research Centre
city: München
country: Germany
facility: Klinikum Rechts der lsar TU München Dept. of Psychiatry and Psychotherapy
city: Schwerin
country: Germany
facility: Kinische Forschung Schwerin GmbH
city: Warendorf
country: Germany
facility: ZMS Zentrum für medizinische Studien GmbH
city: Milano
country: Italy
facility: Ospedale San Raffaele - Centro per i Disturbi del Sonno San Raffaele - Ville-Turro - Pallazzina E
city: Pavia
country: Italy
facility: IRCCS FONDAZIONE Istituto Neurologico Nazionale "Casimiro Mondino" - Centro di Ricerca Interdipartimentale per la SSclerosi Multipla (CRISM) -
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara - Centro di Medicina del Sonno - Clinica Neuroligica - Dipartimento de Neuroscienze
city: Torino
country: Italy
facility: AOU Citta della Salute e della Scienza - Molinette - SSD Medicina del Sonno
city: Gdańsk
country: Poland
facility: PI-House - Centrum Badań Klinicznych
city: Warsaw
country: Poland
facility: Ośrodek Medycyny Study Nurseu Instytutu Psychiatrii i Neurologii (Sleep Disorders Center)
city: Wroclaw
country: Poland
facility: EMC Instytut Medyczny SA, Przychodnia przy Łowieckiej
city: Belgrade
country: Serbia
facility: General Hospital Bel Medic, Center for Sleep disorders
city: Novi Beograd
country: Serbia
facility: Medigroup - Health Center Dr Ristic (MediGroup Dom zdravlja "Dr Ristic") - Neurology Department
city: Barcelona
country: Spain
facility: Centro Médico Teknon - Medicina del Sueño
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron - Neurophisiology Deparment - Sleep Unit
city: Castelló de la Plana
country: Spain
facility: Hospital General de Castellon
city: Madrid
country: Spain
facility: Instituto de Investigaciones del Sueno
city: Madrid
country: Spain
facility: San Carlos University Hospital - Servicio de Neurofisiología Clínica
city: Vitoria-Gasteiz
country: Spain
facility: Hospital Universitario Araba - Unidad Funcional de Trastornos del Sueño
city: Zaragoza
country: Spain
facility: Hospital MAZ - Neurophisiology and Sleep Department
city: Bad Zurzach
country: Switzerland
facility: KSM Bad Zurzach, Klinik für Schlafmedizin
city: Basel
country: Switzerland
facility: Universitäre Psychiatrische Kliniken Basel (Upk)
city: Bern
country: Switzerland
facility: Universitätsklinik für Neurologie, Inselspital Bern, Schlaf-Wach-Epilepsie-Zentrum
city: Wald
country: Switzerland
facility: Zentrum für Schlafmedizin Zürcher Oberland, Zürcher RehaZentrum Wald
city: Wetzikon
country: Switzerland
facility: Zentrum für Schlafmedizin GZO AG Spital Wetzikon
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.
citation: Fietze I, Bassetti CLA, Mayleben DW, Pain S, Seboek Kinter D, McCall WV. Efficacy and Safety of Daridorexant in Older and Younger Adults with Insomnia Disorder: A Secondary Analysis of a Randomised Placebo-Controlled Trial. Drugs Aging. 2022 Oct;39(10):795-810. doi: 10.1007/s40266-022-00977-4. Epub 2022 Sep 13.