Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
NCT ID: NCT03575104
Last Updated: 2022-03-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
924 participants
INTERVENTIONAL
2018-05-29
2020-05-14
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 10 mg
Daridorexant
Daridorexant will be administered as tablets, orally, once daily in the evening.
Daridorexant 25 mg
Daridorexant
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
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 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
* 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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Pulmonary Associates, Pa
Glendale, Arizona, United States
Noble Clinical Research
Tucson, Arizona, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States
Woodland International Research Group
Little Rock, Arkansas, United States
Core Healthcare Group
Cerritos, California, United States
Artemis Institute For Clinical Research - Riverside
Riverside, California, United States
Pacific Research Network
San Diego, California, United States
Artemis Institute for Clinical Research
San Marcos, California, United States
Santa Monica Clinical Trials
Santa Monica, California, United States
Empire Clinical Research
Upland, California, United States
Innovative Clinical Research
Lafayette, Colorado, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
Fleming Island Center for Clinical Research
Fleming Island, Florida, United States
Clinical Trials Research
Lincoln, Florida, United States
Clinical Research Group of St. Petersburgh
St. Petersburg, Florida, United States
Neurotrials Research Incorporated
Atlanta, Georgia, United States
Sleep Practitioners, LLC
Macon, Georgia, United States
Hawaii Pacific Neurosciences
Honolulu, Hawaii, United States
Saltzer Clinical Research
Nampa, Idaho, United States
Rowe Neurology Institute
Lenexa, Kansas, United States
Sleep Disorders Center of the Mid-Atlantic
Glen Burnie, Maryland, United States
Neurocare Inc.
Newton, Massachusetts, United States
Precise Research Centers
Flowood, Mississippi, United States
Garden City Asthma and Sleep Center
Garden City, New York, United States
Research Carolina of Hickory
Hickory, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
Clinical Trials of America - NC, LLC
Winston-Salem, North Carolina, United States
CTI Clinical Research II
Cincinnati, Ohio, United States
Ohio Sleep Medicine Institue
Dublin, Ohio, United States
Cleveland Sleep Research Center
Middleburg Heights, Ohio, United States
Robert V. Sibilia, MD, Inc.
Wooster, Ohio, United States
Brian Abaluck LLC
Paoli, Pennsylvania, United States
Wesley Neurology Clinic Pc (Multiple Sclerosis)
Cordova, Tennessee, United States
FutureSearch Trials of Neurology, LP
Austin, Texas, United States
InSite Clinical Research
DeSoto, Texas, United States
Jacksonville Center for Clinical Research
Jacksonville, Texas, United States
Dm Clinical Research / Martin Diagnostic Clinic
Tomball, Texas, United States
HOSPITAL AZ SINT-JAN_Neurology department
Bruges, , Belgium
Hospital Universitair Zieknhuis Brussel, Pneumology and Sleep Laboratory
Brussels, , Belgium
University Hospital Gent, Department of General Internal Medicine and Center of neurophysiological Monitoring
Ghent, , Belgium
Hospital UZ Leuven_ Pneumology Department
Leuven, , Belgium
Acibadem City Clinic Tokuda Hospital EAD
Sofia, , Bulgaria
Canadian Phase Onward Inc.
Toronto, Ontario, Canada
Queensway Sleep Lab Sleep Clinic (MedSleep)- 5359 Dundas Street West, Suite 202, Etobicoke, ON M9B 1B1
Etobicoke, , Canada
The Medical Arts Health Research Group
Kelowna, , Canada
Somni Research Inc.
Markham, , Canada
Somni Research, Calgary
Toronto, , Canada
CANADIAN PHASE ONWARD INC. (Toronto)
Toronto, , Canada
Nemocnice České Budějovice, Centrum pro poruchy spánku a spánkovou medicínu
České Budějovice, , Czechia
Narodni Ustav Dusevniho Zdravi (National Institute of Mental Health)
Klecany, , Czechia
Fakultní nemocnice Ostrava, Spánková laboratoř
Ostrava-Poruba, , Czechia
Vitalmed Uniklinikka
Helsinki, , Finland
Oivauni Oy - Kuopio
Kuopio, , Finland
Oivauni Oy - Tampere
Tampere, , Finland
Unitutkimusyksikkö, Turun Yliopisto
Turku, , Finland
CHRU De Lille - Hospital Salengro - Neurophysiologie Clinique
Lille, , France
Clinique beau soleil - Department Sleep and Neurology
Montpellier, , France
CHU NIMES - Unité de Sommeil
Nîmes, , France
Advanced Sleep Research GmbH
Berlin, , Germany
Klinische Forschung Berlin-Mitte GmbH
Berlin, , Germany
Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin Kompetenzzentrum Schlafmedizin
Berlin, , Germany
Synexus Clinical Research GmbH
Bochum, , Germany
Klinische Forschung Dresden GmbH
Dresden, , Germany
Synexus Clinical Research GmbH
Frankfurt, , Germany
Klinische Forschung Hannover Mitte GmbH
Hanover, , Germany
Interdisziplinäre Schlafmedizin, Pfalzklinikum
Klingenmünster, , Germany
Zentrum für Integrative Psychiatrie (ZiP) Universität zu Lübeck
Lübeck, , Germany
Central Insitute of Mental Health Sleep laboratory Medical Faculty Mannheim/Heidelberg University
Mannheim, , Germany
Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie der Universität am Bezirksklinikum Regensburg
Regensburg, , Germany
SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
Schwerin, , Germany
Magyar Honvédség Egészségügyi Központ, Neurológiai Osztály
Budapest, , Hungary
Somnius Kft. SomnoCenter Szeged
Szeged, , Hungary
Dong-A University Hospital
Busan, , South Korea
4F Neuroimaging analysis laboratory, 56 Dalseong-ro, Jung-gu
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
3F, 2nd Building, Psychiatry Outpatient, Family Counseling Room, 42 Jebong-ro, Donggu
Gwangju, , South Korea
8F Sleep Lab, 1st Building,82, Gumi-ro 173 Beon-gil, Bundang-gu
Seongnam, , South Korea
3F Sleep Medicine Center, 101 Daehak-Ro Jongno-Gu
Seoul, , South Korea
1st CRC room, 2F, Jejoong building, 50-1 Yonsei-ro,, Seodaemun-gu
Seoul, , South Korea
B2F, Clinical Trial Center, Konkuk University Medical Center 120-1, Neungdong-ro, Gwangjin-gu
Seoul, , South Korea
B1F Neurological examination room, 892 Dongnam-ro, Gangdong-gu
Seoul, , South Korea
2F Psychiatry Outpatient, 93, Jungbu-daero, Paldal-gu
Suwon, , South Korea
Göteborgs Universitet, Centrum för sömn och vakenhetsstörningar
Gothenburg, , Sweden
Universitetssjukhuset Örebro Neurokliniken, Sömnenheten
Örebro, , Sweden
SOPHIAHEMMET (Stockholm)
Stockholm, , Sweden
Sömnutredningsmottagningen, smärtcentrum Akademiska sjukhuset
Uppsala, , Sweden
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.
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.
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.
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-078A302
Identifier Type: -
Identifier Source: org_study_id
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