Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder
NCT ID: NCT03545191
Last Updated: 2022-03-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
930 participants
INTERVENTIONAL
2018-06-04
2020-02-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Daridorexant 25 mg
Daridorexant 25 mg
Daridorexant will be administered as tablets, orally, once daily in the evening.
Daridorexant 50 mg
Daridorexant 50 mg
Daridorexant will be administered as tablets, orally, once daily in the evening.
Placebo
Placebo
Matching placebo will be administered as tablets, orally, once daily in the evening.
Interventions
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Daridorexant 25 mg
Daridorexant will be administered as tablets, orally, once daily in the evening.
Daridorexant 50 mg
Daridorexant will be administered as tablets, orally, once daily in the evening.
Placebo
Matching placebo will be administered as tablets, orally, once daily in the evening.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Idorsia Pharmaceuticals Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Idorsia Pharmaceuticals Ltd.
Locations
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Pinnacle Research Group, LLC
Anniston, Alabama, United States
Pulmonary Associates of the Southeast/WCR
Birmingham, Alabama, United States
Preferred Research Partners, Inc
Little Rock, Arkansas, United States
Woodland Research Northwest
Rogers, Arkansas, United States
Marvel Clinical Research
Huntington Beach, California, United States
Long Beach Clinical Trials
Long Beach, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
PAB Clinical Research
Brandon, Florida, United States
St. Francis Sleep Allergy and Lung Institute
Clearwater, Florida, United States
Innovative Clinical Research, Inc.
Hialeah, Florida, United States
Research Centers of America
Hollywood, Florida, United States
Canvas Clinical Research, LLC
Lake Worth, Florida, United States
BioMed Research Institute
Miami, Florida, United States
Clinical Site Partners, LLC
Winter Park, Florida, United States
LaPorte County Institute for Clinical Research
Michigan City, Indiana, United States
Kentucky Research Group
Louisville, Kentucky, United States
Helene Emsellem, MD
Chevy Chase, Maryland, United States
Infinity Medical Research, Inc.
North Dartmouth, Massachusetts, United States
Barrett Clinic
La Vista, Nebraska, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, United States
Clinilabs NYC
New York, New York, United States
Research Carolina of Huntersville
Huntersville, North Carolina, United States
Coastal Carolina Healthcare
New Bern, North Carolina, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Oregon Center for Clinical Investigations,Inc
Salem, Oregon, United States
BTC of Lincoln
Lincoln, Rhode Island, United States
Omega Medical Research
Warwick, Rhode Island, United States
Bogan Sleep Consulting, LLC
Columbia, South Carolina, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Tri-State Mountain Neurology
Johnson City, Tennessee, United States
Inquest Clinical Research
Baytown, Texas, United States
Sleep Therapy & Research Center
San Antonio, Texas, United States
Aspen Clinical Research
Orem, Utah, United States
Pulmonary Associates of Richmond
Richmond, Virginia, United States
Sleep Disorders Centers of the Mid-Atlantic
Vienna, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Respiratory Clinical Trials
Adelaide, , Australia
Genesis Sleep Care Queensland
Auchenflower, , Australia
Melbourne Sleep Disorders Centre
East Melbourne, , Australia
The Woolcock Institute of Medical Research
Glebe, , Australia
Royal Melbourne Hospital, Department of Respiratory Medicine
Parkville, , Australia
Gold Coast University Hospital, Respiratory Medicine and Sleep Services
Southport, , Australia
Westmead Hospital, Department of Respiratory and Sleep Medicine
Westmead, , Australia
Tri-Hospital Sleep Laboratory West
Mississauga, , Canada
CRIUSMQ- CIUSSSCN, CETS (clinique du sommeil)
Québec, , Canada
MedSleep
Toronto, , Canada
Jodha Tishon Inc.
Toronto, , Canada
Scan Sleep Specialists
Copenhagen, , Denmark
St Hedwig-Krankenhaus, Klinik für Schlaf- und Chronomedizin
Berlin, , Germany
emovis GmbH
Berlin, , Germany
Synexus Berlin Research Centre
Berlin, , Germany
Clinical Trial Center North GmbH & Co. KG
Hamburg, , Germany
Klinische Forschung Hamburg GmbH
Hamburg, , Germany
Klinische Forschung Karlsruhe GmbH
Karlsruhe, , Germany
Studienzentrum Wilhelmshöhe GmbH
Kassel, , Germany
Synexus Leipzig Research Centre
Leipzig, , Germany
Klinikum Rechts der lsar TU München Dept. of Psychiatry and Psychotherapy
München, , Germany
Kinische Forschung Schwerin GmbH
Schwerin, , Germany
ZMS Zentrum für medizinische Studien GmbH
Warendorf, , Germany
Ospedale San Raffaele - Centro per i Disturbi del Sonno San Raffaele - Ville-Turro - Pallazzina E
Milan, , Italy
IRCCS FONDAZIONE Istituto Neurologico Nazionale "Casimiro Mondino" - Centro di Ricerca Interdipartimentale per la SSclerosi Multipla (CRISM) -
Pavia, , Italy
Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara - Centro di Medicina del Sonno - Clinica Neuroligica - Dipartimento de Neuroscienze
Pisa, , Italy
AOU Citta della Salute e della Scienza - Molinette - SSD Medicina del Sonno
Torino, , Italy
PI-House - Centrum Badań Klinicznych
Gdansk, , Poland
Ośrodek Medycyny Study Nurseu Instytutu Psychiatrii i Neurologii (Sleep Disorders Center)
Warsaw, , Poland
EMC Instytut Medyczny SA, Przychodnia przy Łowieckiej
Wroclaw, , Poland
General Hospital Bel Medic, Center for Sleep disorders
Belgrade, , Serbia
Medigroup - Health Center Dr Ristic (MediGroup Dom zdravlja "Dr Ristic") - Neurology Department
New Belgrade, , Serbia
Centro Médico Teknon - Medicina del Sueño
Barcelona, , Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, , Spain
Hospital Universitari Vall d'Hebron - Neurophisiology Deparment - Sleep Unit
Barcelona, , Spain
Hospital General de Castellon
Castellon, , Spain
Instituto de Investigaciones del Sueno
Madrid, , Spain
San Carlos University Hospital - Servicio de Neurofisiología Clínica
Madrid, , Spain
Hospital Universitario Araba - Unidad Funcional de Trastornos del Sueño
Vitoria-Gasteiz, , Spain
Hospital MAZ - Neurophisiology and Sleep Department
Zaragoza, , Spain
KSM Bad Zurzach, Klinik für Schlafmedizin
Bad Zurzach, , Switzerland
Universitäre Psychiatrische Kliniken Basel (Upk)
Basel, , Switzerland
Universitätsklinik für Neurologie, Inselspital Bern, Schlaf-Wach-Epilepsie-Zentrum
Bern, , Switzerland
Zentrum für Schlafmedizin Zürcher Oberland, Zürcher RehaZentrum Wald
Wald, , Switzerland
Zentrum für Schlafmedizin GZO AG Spital Wetzikon
Wetzikon, , Switzerland
Countries
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References
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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.
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.
Lettieri CJ, Briasoulis O, Leger D, Luyet PP, Pepin JL, Quan SF, Raphelson J, Saskin P, Malhotra A. The Effects of Daridorexant on Patients With Comorbid Insomnia Disorder and Untreated Mild Obstructive Sleep Apnoea: A Post Hoc Subgroup Analysis of a Phase 3, Randomised Clinical Trial. J Sleep Res. 2025 Jul 14:e70135. doi: 10.1111/jsr.70135. Online ahead of print.
Dauvilliers Y, Braunstein G, Zammit G, Olivieri A, Luyet PP. Effect of daridorexant on nighttime wakefulness and next-morning sleepiness: assessing the transition from night to day in insomnia disorder. Sleep Med. 2025 Jul;131:106523. doi: 10.1016/j.sleep.2025.106523. Epub 2025 Apr 17.
Di Marco T, Djonlagic I, Dauvilliers Y, Sadeghi K, Little D, Datta AN, Hubbard J, Hajak G, Krystal A, Olivieri A, Parrino L, Puryear CB, Zammit G, Donoghue J, Scammell TE. Effect of daridorexant on sleep architecture in patients with chronic insomnia disorder: a pooled post hoc analysis of two randomized phase 3 clinical studies. Sleep. 2024 Nov 8;47(11):zsae098. doi: 10.1093/sleep/zsae098.
Phillips-Beyer A, Kawata AK, Kleinman L, Seboek Kinter D, Flamion B. Meaningful Within-Patient Change in Subjective Total Sleep Time in Patients with Insomnia Disorder: An Analysis of the Sleep Diary Questionnaire Using Data from Open-Label and Phase III Clinical Trials. Pharmaceut Med. 2024 Mar;38(2):133-144. doi: 10.1007/s40290-023-00512-9. Epub 2024 Feb 1.
Citrome L, Juday TR, Lundwall C. Lemborexant and Daridorexant for the Treatment of Insomnia: An Indirect Comparison Using Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed. J Clin Psychiatry. 2023 Oct 2;84(6):23m14851. doi: 10.4088/JCP.23m14851.
Dutta S, Singhal S, Shah R, Charan J, Dhingra S, Haque M. Daridorexant as a novel pharmacotherapeutic approach in insomnia: a systematic review and meta-analysis. Expert Opin Drug Saf. 2023 Jul-Dec;22(12):1237-1251. doi: 10.1080/14740338.2023.2243217. Epub 2023 Aug 7.
Di Marco T, Scammell TE, Meinel M, Seboek Kinter D, Datta AN, Zammit G, Dauvilliers Y. Number, Duration, and Distribution of Wake Bouts in Patients with Insomnia Disorder: Effect of Daridorexant and Zolpidem. CNS Drugs. 2023 Jul;37(7):639-653. doi: 10.1007/s40263-023-01020-9. Epub 2023 Jul 21.
Phillips-Beyer A, Kawata AK, Kleinman L, Kinter DS. Meaningful Within-Patient Change on the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ): Analysis of Phase III Clinical Trial Data of Daridorexant. Pharmaceut Med. 2023 Jul;37(4):291-303. doi: 10.1007/s40290-023-00484-w. Epub 2023 Jun 7.
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.
Heidenreich S, Ross M, Chua GN, Seboek Kinter D, Phillips-Beyer A. Preferences of patients for benefits and risks of insomnia medications using data elicited during two phase III clinical trials. Sleep. 2022 Nov 9;45(11):zsac204. doi: 10.1093/sleep/zsac204.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ID-078A301
Identifier Type: -
Identifier Source: org_study_id
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