Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
NCT ID: NCT03679884
Last Updated: 2022-03-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
804 participants
INTERVENTIONAL
2018-10-09
2021-02-22
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
Film-coated tablets administered orally, once daily in the evening
Daridorexant 10 mg
Daridorexant 10 mg film-coated tablets
Daridorexant 25 mg
Film-coated tablets administered orally, once daily in the evening
Daridorexant 25 mg
Daridorexant 25 mg film-coated tablets
Daridorexant 50 mg
Film-coated tablets administered orally, once daily in the evening
Daridorexant 50 mg
Daridorexant 50 mg film-coated tablets
Placebo
Film-coated tablets administered orally, once daily in the evening
Placebo
Matching placebo film-coated tablets
Ex-Placebo Daridorexant 25 mg
Film-coated tablets administered orally, once daily in the evening
Daridorexant 25 mg
Daridorexant 25 mg film-coated tablets
Interventions
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Daridorexant 10 mg
Daridorexant 10 mg film-coated tablets
Daridorexant 25 mg
Daridorexant 25 mg film-coated tablets
Daridorexant 50 mg
Daridorexant 50 mg film-coated tablets
Placebo
Matching placebo film-coated tablets
Eligibility Criteria
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Inclusion Criteria
* Having completed the DB study treatment and the run-out period of ID-078A301 (NCT03545191) or ID-078A302 (NCT03575104).
* For woman of childbearing potential, the following is required:
* Negative urine pregnancy test (EOT of ID-078A301 or ID-078A302 studies)
* Agreement to use the contraception scheme as required by the protocol from Visit 1 up to at least 30 days after EODBT.
Exclusion Criteria
* For female subjects: lactating or planning to become pregnant during the duration of the study (Visit 1).
* Positive urine drug test (for benzodiazepines, barbiturates, cannabinoids, opiates, amphetamines, or cocaine) or presence of alcohol in exhaled breath as detected by breathalyzer test (EOT of ID-078A301 or ID-078A302 studies if same day as Visit 1 or Visit 1 if within 7 days after EOT).
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 of the Southeast/WCR
Birmingham, Alabama, United States
Pulmonary Associates, Pa
Glendale, Arizona, United States
Noble Clinical Research
Tucson, Arizona, United States
Preferred Research Partners, Inc
Little Rock, Arkansas, United States
Woodland International Research Group
Little Rock, Arkansas, United States
Core Healthcare Group
Cerritos, California, United States
Marvel Clinical Research
Huntington Beach, California, United States
Clinical Trials Research
Lincoln, California, United States
Long Beach Clinical Trials
Long Beach, California, United States
Artemis Institute For Clinical Research - Riverside
Riverside, California, United States
Artemis institute for Clinical Research
San Diego, 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
PAB Clinical Research
Brandon, Florida, United States
St. Francis Sleep Allergy and Lung Institute
Clearwater, Florida, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
Fleming Island Center for Clinical Research
Fleming Island, 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 Research Group of St. Petersburgh
St. Petersburg, Florida, United States
Clinical Site Partners, LLC
Winter Park, Florida, United States
Neurotrials Research Incorporated
Atlanta, Georgia, United States
Sleep Practitioners, LLC
Macon, Georgia, United States
Saltzer Clinical Research
Nampa, Idaho, United States
Helene Emsellem, MD
Chevy Chase, Maryland, United States
Sleep Disorders Center of the Mid-Atlantic
Glen Burnie, Maryland, United States
Infinity Medical Research, Inc.
North Dartmouth, Massachusetts, United States
Precise Research Centers
Flowood, Mississippi, 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 Hickory
Hickory, North Carolina, United States
Research Carolina of Huntersville
Huntersville, North Carolina, United States
Coastal Carolina Healthcare
New Bern, 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
CTI Clinical Research Center
Cincinnati, Ohio, United States
Aventiv Research Inc.
Dublin, Ohio, United States
Cleveland Sleep Research Center
Middleburg Heights, Ohio, United States
Oregon Center for Clinical Investigations,Inc
Salem, Oregon, United States
Brian Abaluck LLC
Paoli, Pennsylvania, United States
Omega Medical Research
Warwick, Rhode Island, United States
FutureSearch Trials of Neurology, LP
Austin, Texas, United States
Inquest Clinical Research
Baytown, Texas, United States
InSite Clinical Research
DeSoto, Texas, United States
Jacksonville Center for Clinical Research
Jacksonville, Texas, United States
Sleep Disorders Centers of the Mid-Atlantic
Vienna, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Hospital UZ Leuven_ Pneumology Department
Leuven, , Belgium
Acibadem City Clinic Tokuda Hospital EAD
Sofia, , Bulgaria
Queensway Sleep Lab Sleep Clinic (MedSleep)
Etobicoke, , Canada
The Medical Arts Health Research Group
Kelowna, , Canada
Somni Research Inc.
Markham, , Canada
CRIUSMQ- CIUSSSCN, CETS (clinique du sommeil)
Québec, , Canada
CANADIAN PHASE ONWARD INC. (Toronto)
Toronto, , Canada
MedSleep
Toronto, , Canada
Jodha Tishon Inc.
Toronto, , Canada
Scan Sleep Specialists
Copenhagen, , Denmark
Vitalmed Uniklinikka
Helsinki, , Finland
Oivauni Oy - Kuopio
Kuopio, , Finland
Oivauni Oy - Tampere
Tampere, , Finland
Unitutkimusyksikkö, Turun Yliopisto
Turku, , Finland
CHU NIMES - Unité de Sommeil
Nîmes, , France
St Hedwig-Krankenhaus, Klinik für Schlaf- und Chronomedizin
Berlin, , Germany
Klinische Forschung Berlin-Mitte GmbH
Berlin, , Germany
emovis GmbH
Berlin, , Germany
Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin Kompetenzzentrum Schlafmedizin
Berlin, , Germany
Synexus Berlin Research Centre
Berlin, , Germany
Synexus Clinical Research GmbH
Bochum, , Germany
Klinische Forschung Dresden GmbH
Dresden, , Germany
Klinik imd Poliklinik fur Neurochirurgie
Dresden, , Germany
Synexus Clinical Research GmbH
Frankfurt, , Germany
Clinical Trial Center North GmbH & Co. KG
Hamburg, , Germany
Klinische Forschung Hamburg GmbH
Hamburg, , Germany
Klinische Forschung Hannover Mitte GmbH
Hanover, , Germany
Klinische Forschung Karlsruhe GmbH
Karlsruhe, , Germany
Studienzentrum Wilhelmshöhe GmbH
Kassel, , Germany
Synexus Leipzig Research Centre
Leipzig, , 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
Klinikum Rechts der lsar TU München Dept. of Psychiatry and Psychotherapy
München, , 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
Kinische Forschung Schwerin GmbH
Schwerin, , Germany
ZMS Zentrum für medizinische Studien GmbH
Warendorf, , Germany
Magyar Honvédség Egészségügyi Központ, Neurológiai Osztály
Budapest, , Hungary
Somnius Kft. SomnoCenter Szeged
Szeged, , Hungary
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
4F Neuroimaging analysis laboratory, 56 Dalseong-ro, Jung-gu
Daegu, , South Korea
2F Psychiatry Outpatient, 93, Jungbu-daero, Paldal-gu
Suwon, , South Korea
Centro Médico Teknon - Medicina del Sueño
Barcelona, , Spain
Hospital Universitari Vall d'Hebron - Neurophisiology Deparment - Sleep Unit
Barcelona, , Spain
Instituto de Investigaciones del Sueno
Madrid, , Spain
Hospital Universitario Araba - Unidad Funcional de Trastornos del Sueño
Vitoria-Gasteiz, , Spain
Hospital MAZ - Neurophisiology and Sleep Department
Zaragoza, , Spain
Göteborgs Universitet, Centrum för sömn och vakenhetsstörningar
Gothenburg, , Sweden
Universitetssjukhuset Örebro Neurokliniken, Sömnenheten
Örebro, , Sweden
Sömnutredningsmottagningen, smärtcentrum Akademiska sjukhuset
Uppsala, , Sweden
Zentrum für Schlafmedizin Zürcher Oberland, Zürcher RehaZentrum Wald
Wald, , Switzerland
Countries
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References
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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.
Kunz D, Dauvilliers Y, Benes H, Garcia-Borreguero D, Plazzi G, Seboek Kinter D, Coloma P, Rausch M, Sassi-Sayadi M, Thein S. Long-Term Safety and Tolerability of Daridorexant in Patients with Insomnia Disorder. CNS Drugs. 2023 Jan;37(1):93-106. doi: 10.1007/s40263-022-00980-8. Epub 2022 Dec 9.
Provided Documents
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Document Type: Study Protocol: Study Protocol
Document Type: Study Protocol: Study Protocol Addendum
Document Type: Statistical Analysis Plan
Other Identifiers
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ID-078A303
Identifier Type: -
Identifier Source: org_study_id
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