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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03679884
Other study ID # ID-078A303
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 9, 2018
Est. completion date February 22, 2021

Study information

Verified date February 2022
Source Idorsia Pharmaceuticals Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study to assess the long term safety and tolerability of daridorexant in adult and elderly subjects suffering from difficulties to sleep


Recruitment information / eligibility

Status Completed
Enrollment 804
Est. completion date February 22, 2021
Est. primary completion date February 22, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Signed informed consent prior to any study-mandated procedure (Visit 1). - 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: - Unstable medical condition, significant medical disorder or acute illness, C-SSRS©, ECG, hematology or biochemistry test results in ID-078A301 and ID-078A302, which in the opinion of the investigator could affect the subject's safety or interfere with the study assessments (Visit 1). - 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).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
Belgium Hospital UZ Leuven_ Pneumology Department Leuven
Bulgaria Acibadem City Clinic Tokuda Hospital EAD Sofia
Canada 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) Quebec
Canada CANADIAN PHASE ONWARD INC. (Toronto) Toronto
Canada Jodha Tishon Inc. Toronto
Canada MedSleep Toronto
Denmark Scan Sleep Specialists København
Finland Vitalmed Uniklinikka Helsinki
Finland Oivauni Oy - Kuopio Kuopio
Finland Oivauni Oy - Tampere Tampere
Finland Unitutkimusyksikkö, Turun Yliopisto Turku
France CHU NIMES - Unité de Sommeil Nîmes
Germany Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin Kompetenzzentrum Schlafmedizin Berlin
Germany emovis GmbH Berlin
Germany Klinische Forschung Berlin-Mitte GmbH Berlin
Germany St Hedwig-Krankenhaus, Klinik für Schlaf- und Chronomedizin Berlin
Germany Synexus Berlin Research Centre Berlin
Germany Synexus Clinical Research GmbH Bochum
Germany Klinik imd Poliklinik fur Neurochirurgie Dresden
Germany Klinische Forschung Dresden GmbH 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 Hannover
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 Kinische Forschung Schwerin GmbH Schwerin
Germany SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH Schwerin
Germany ZMS Zentrum für medizinische Studien GmbH Warendorf
Hungary Magyar Honvédség Egészségügyi Központ, Neurológiai Osztály Budapest
Hungary Somnius Kft. SomnoCenter Szeged Szeged
Korea, Republic of 4F Neuroimaging analysis laboratory, 56 Dalseong-ro, Jung-gu Daegu
Korea, Republic of 2F Psychiatry Outpatient, 93, Jungbu-daero, Paldal-gu Suwon
Poland PI-House - Centrum Badan Klinicznych Gdansk
Poland Osrodek Medycyny Study Nurseu Instytutu Psychiatrii i Neurologii (Sleep Disorders Center) Warsaw
Poland EMC Instytut Medyczny SA, Przychodnia przy Lowieckiej Wroclaw
Spain 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
Sweden Göteborgs Universitet, Centrum för sömn och vakenhetsstörningar Göteborg
Sweden Universitetssjukhuset Örebro Neurokliniken, Sömnenheten Örebro
Sweden Sömnutredningsmottagningen, smärtcentrum Akademiska sjukhuset Uppsala
Switzerland Zentrum für Schlafmedizin Zürcher Oberland, Zürcher RehaZentrum Wald Wald
United States Neurotrials Research Incorporated Atlanta Georgia
United States FutureSearch Trials of Neurology, LP Austin Texas
United States Inquest Clinical Research Baytown Texas
United States Pulmonary Associates of the Southeast/WCR Birmingham Alabama
United States PAB Clinical Research Brandon Florida
United States Core Healthcare Group Cerritos California
United States Helene Emsellem, MD Chevy Chase Maryland
United States CTI Clinical Research Center Cincinnati Ohio
United States CTI Clinical Research II Cincinnati Ohio
United States St. Francis Sleep Allergy and Lung Institute Clearwater Florida
United States Clinical Research of South Florida Coral Gables Florida
United States InSite Clinical Research DeSoto Texas
United States Aventiv Research Inc. Dublin Ohio
United States Fleming Island Center for Clinical Research Fleming Island Florida
United States Precise Research Centers Flowood Mississippi
United States Sleep Disorders Center of the Mid-Atlantic Glen Burnie Maryland
United States Pulmonary Associates, Pa Glendale Arizona
United States Research Carolina of Hickory Hickory North Carolina
United States Research Centers of America Hollywood Florida
United States Research Carolina of Huntersville Huntersville North Carolina
United States Marvel Clinical Research Huntington Beach California
United States Jacksonville Center for Clinical Research Jacksonville Texas
United States Barrett Clinic La Vista Nebraska
United States Innovative Clinical Research Lafayette Colorado
United States Canvas Clinical Research, LLC Lake Worth Florida
United States Clinical Research Center of Nevada Las Vegas Nevada
United States Clinical Trials Research Lincoln California
United States Preferred Research Partners, Inc Little Rock Arkansas
United States Woodland International Research Group Little Rock Arkansas
United States Long Beach Clinical Trials Long Beach California
United States Sleep Practitioners, LLC Macon Georgia
United States BioMed Research Institute Miami Florida
United States Cleveland Sleep Research Center Middleburg Heights Ohio
United States Saltzer Clinical Research Nampa Idaho
United States Coastal Carolina Healthcare New Bern North Carolina
United States Clinilabs NYC New York New York
United States Infinity Medical Research, Inc. North Dartmouth Massachusetts
United States Brian Abaluck LLC Paoli Pennsylvania
United States Wake Research Associates Raleigh North Carolina
United States Artemis Institute For Clinical Research - Riverside Riverside California
United States Clinical Research Group of St. Petersburgh Saint Petersburg Florida
United States Oregon Center for Clinical Investigations,Inc Salem Oregon
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 Swedish Medical Center Seattle Washington
United States Noble Clinical Research Tucson Arizona
United States Empire Clinical Research Upland California
United States Sleep Disorders Centers of the Mid-Atlantic Vienna Virginia
United States Omega Medical Research Warwick Rhode Island
United States Clinical Trials of America - NC, LLC Winston-Salem North Carolina
United States Clinical Site Partners, LLC Winter Park Florida

Sponsors (1)

Lead Sponsor Collaborator
Idorsia Pharmaceuticals Ltd.

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Canada,  Denmark,  Finland,  France,  Germany,  Hungary,  Korea, Republic of,  Poland,  Spain,  Sweden,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total no. of Subjects With at Least One TEAE The primary objective of the study was to assess the long-term safety and tolerability of 10, 25 and 50 mg daridorexant.
The total no. of subjects with at least one TEAE is presented here; no statistical analysis was conducted.
The full set of safety data is available in the Section "Adverse events".
TEAEs (AEs that started or worsened during the double-blind study period up to 30 days after double-blind study treatment end date) are reported. Total duration: up to 44 weeks.
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