Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep

Multi-center, Double-blind, Parallel-group, Randomized, Placebo-controlled, Three Doses, 40-week Extension to Studies ID-078A301 and ID-078A302 to Assess the Long Term Safety and Tolerability of ACT-541468 in Adult and Elderly Subjects With Insomnia Disorder

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

Study Overview

• Status: Completed
• Conditions: Insomnia Disorder
• Intervention / Treatment: Drug: Daridorexant 10 mg; Drug: Daridorexant 25 mg; Drug: Daridorexant 50 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 804
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Hospital UZ Leuven_ Pneumology Department
• Bulgaria
  • Sofia, Bulgaria, 1407
    • Acibadem City Clinic Tokuda Hospital Ead
• Canada
  • Etobicoke, Canada, M9C 5N2
    • Queensway Sleep Lab Sleep Clinic (MedSleep)
  • Kelowna, Canada, V1Y 3G8
    • The Medical Arts Health Research Group
  • Markham, Canada, L3R 1A3
    • Somni Research Inc.
  • Quebec, Canada, G1J 2G2
    • CRIUSMQ- CIUSSSCN, CETS (clinique du sommeil)
  • Toronto, Canada, M4P 1P2
    • MedSleep
  • Toronto, Canada, M5G1N8
    • Jodha Tishon Inc.
  • Toronto, Canada, M3J 0K2
    • CANADIAN PHASE ONWARD INC. (Toronto)
• Denmark
  • København, Denmark, 1053
    • Scan Sleep Specialists
• Finland
  • Helsinki, Finland, 380
    • Vitalmed Uniklinikka
  • Kuopio, Finland, 70100
    • Oivauni Oy - Kuopio
  • Tampere, Finland
    • Oivauni Oy - Tampere
  • Turku, Finland
    • Unitutkimusyksikkö, Turun Yliopisto
• France
  • Nîmes, France, 30029
    • CHU NIMES - Unité de Sommeil
• Germany
  • Berlin, Germany, 10629
    • emovis GmbH
  • Berlin, Germany, 10115
    • St Hedwig-Krankenhaus, Klinik für Schlaf- und Chronomedizin
  • Berlin, Germany, 12627
    • Synexus Berlin Research Centre
  • Berlin, Germany, 10117
    • Klinische Forschung Berlin-Mitte GmbH
  • Berlin, Germany, 12200
    • Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin Kompetenzzentrum Schlafmedizin
  • Bochum, Germany, 44787
    • Synexus Clinical Research GmbH
  • Dresden, Germany, 1069
    • Klinische Forschung Dresden GmbH
  • Dresden, Germany, 1307
    • Klinik imd Poliklinik fur Neurochirurgie
  • Frankfurt, Germany, 60313
    • Synexus Clinical Research GmbH
  • Hamburg, Germany, 20253
    • Klinische Forschung Hamburg GmbH
  • Hamburg, Germany, 20251
    • Clinical Trial Center North GmbH & Co. KG
  • Hannover, Germany, 30159
    • Klinische Forschung Hannover Mitte GmbH
  • Karlsruhe, Germany, 76137
    • Klinische Forschung Karlsruhe GmbH
  • Kassel, Germany, 34131
    • Studienzentrum Wilhelmshöhe GmbH
  • Leipzig, Germany, 4103
    • Synexus Leipzig Research Centre
  • Lübeck, Germany, 23538
    • Zentrum für Integrative Psychiatrie (ZiP) Universität zu Lübeck
  • Mannheim, Germany, 68159
    • Central Insitute of Mental Health Sleep laboratory Medical Faculty Mannheim/Heidelberg University
  • München, Germany, 81675
    • Klinikum Rechts der lsar TU München Dept. of Psychiatry and Psychotherapy
  • Regensburg, Germany, 93053
    • Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie der Universität am Bezirksklinikum Regensburg
  • Schwerin, Germany, 19055
    • Kinische Forschung Schwerin GmbH
  • Schwerin, Germany, 19053
    • SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
  • Warendorf, Germany, 48231
    • ZMS Zentrum für medizinische Studien GmbH
• Hungary
  • Budapest, Hungary, 1134
    • Magyar Honvédség Egészségügyi Központ, Neurológiai Osztály
  • Szeged, Hungary, 6725
    • Somnius Kft. SomnoCenter Szeged
• Korea, Republic of
  • Daegu, Korea, Republic of, 41931
    • 4F Neuroimaging analysis laboratory, 56 Dalseong-ro, Jung-gu
  • Suwon, Korea, Republic of, 16247
    • 2F Psychiatry Outpatient, 93, Jungbu-daero, Paldal-gu
• Poland
  • Gdańsk, Poland, 80-546
    • PI-House - Centrum Badań Klinicznych
  • Warsaw, Poland, 02-957
    • Ośrodek Medycyny Study Nurseu Instytutu Psychiatrii i Neurologii (Sleep Disorders Center)
  • Wroclaw, Poland, 50220
    • EMC Instytut Medyczny SA, Przychodnia przy Łowieckiej
• Spain
  • Barcelona, Spain, 8017
    • Centro Médico Teknon - Medicina del Sueño
  • Barcelona, Spain, 8035
    • Hospital Universitari Vall d'Hebron - Neurophisiology Deparment - Sleep Unit
  • Madrid, Spain, 28036
    • Instituto de Investigaciones del Sueño
  • Vitoria-Gasteiz, Spain, 1004
    • Hospital Universitario Araba - Unidad Funcional de Trastornos del Sueño
  • Zaragoza, Spain, 50015
    • Hospital MAZ - Neurophisiology and Sleep Department
• Sweden
  • Göteborg, Sweden, 41390
    • Göteborgs Universitet, Centrum för sömn och vakenhetsstörningar
  • Uppsala, Sweden, 75185
    • Sömnutredningsmottagningen, smärtcentrum Akademiska sjukhuset
  • Örebro, Sweden, 70185
    • Universitetssjukhuset Örebro Neurokliniken, Sömnenheten
• Switzerland
  • Wald, Switzerland, 8636
    • Zentrum für Schlafmedizin Zürcher Oberland, Zürcher RehaZentrum Wald
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Pulmonary Associates of the Southeast/WCR
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Pulmonary Associates, PA
    • Tucson, Arizona, United States, 85704
      • Noble Clinical Research
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Woodland International Research Group
    • Little Rock, Arkansas, United States, 72211
      • Preferred Research Partners, Inc
  • California
    • Cerritos, California, United States, 90703
      • Core Healthcare Group
    • Huntington Beach, California, United States, 92647
      • Marvel Clinical Research
    • Lincoln, California, United States, 95648
      • Clinical Trials Research
    • Long Beach, California, United States, 90806
      • Long Beach Clinical Trials
    • Riverside, California, United States, 92503
      • Artemis Institute for Clinical Research - Riverside
    • San Diego, California, United States, 92103
      • Pacific Research Network
    • San Diego, California, United States, 92103
      • Artemis Institute for Clinical Research
    • San Marcos, California, United States, 92078
      • Artemis Institute for Clinical Research
    • Santa Monica, California, United States, 90404
      • Santa Monica Clinical Trials
    • Upland, California, United States, 91786
      • Empire Clinical Research
  • Colorado
    • Lafayette, Colorado, United States, 80026
      • Innovative Clinical Research
  • Florida
    • Brandon, Florida, United States, 33511
      • PAB Clinical Research
    • Clearwater, Florida, United States, 33765
      • St. Francis Sleep Allergy and Lung Institute
    • Coral Gables, Florida, United States, 33134
      • Clinical Research of South Florida
    • Fleming Island, Florida, United States, 32003
      • Fleming Island Center for Clinical Research
    • Hollywood, Florida, United States, 33024
      • Research Centers of America
    • Lake Worth, Florida, United States, 33467
      • Canvas Clinical Research, LLC
    • Miami, Florida, United States, 33126
      • BioMed Research Institute
    • Saint Petersburg, Florida, United States, 33707
      • Clinical Research Group of St. Petersburgh
    • Winter Park, Florida, United States, 32789
      • Clinical Site Partners, LLC
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Neurotrials Research Incorporated
    • Macon, Georgia, United States, 31210
      • Sleep Practitioners, LLC
  • Idaho
    • Nampa, Idaho, United States, 83686
      • Saltzer Clinical Research
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Helene Emsellem, MD
    • Glen Burnie, Maryland, United States, 21061
      • Sleep Disorders Center of the Mid-Atlantic
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
      • Infinity Medical Research, Inc.
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Precise Research Centers
  • Nebraska
    • La Vista, Nebraska, United States, 68128
      • Barrett Clinic
  • Nevada
    • Las Vegas, Nevada, United States, 89104
      • Clinical Research Center Of Nevada
  • New York
    • New York, New York, United States, 10019
      • Clinilabs NYC
  • North Carolina
    • Hickory, North Carolina, United States, 28601
      • Research Carolina of Hickory
    • Huntersville, North Carolina, United States, 28078
      • Research Carolina of Huntersville
    • New Bern, North Carolina, United States, 28562
      • Coastal Carolina Healthcare
    • Raleigh, North Carolina, United States, 27604-1547
      • Wake Research Associates
    • Winston-Salem, North Carolina, United States, 27103
      • Clinical Trials of America - NC, LLC
  • Ohio
    • Cincinnati, Ohio, United States, 45255
      • CTI Clinical Research Center
    • Cincinnati, Ohio, United States, 45212
      • CTI Clinical Research II
    • Dublin, Ohio, United States, 43016
      • Aventiv Research Inc.
    • Middleburg Heights, Ohio, United States, 44130
      • Cleveland Sleep Research Center
  • Oregon
    • Salem, Oregon, United States, 97301
      • Oregon Center for Clinical Investigations,Inc
  • Pennsylvania
    • Paoli, Pennsylvania, United States, 19301
      • Brian Abaluck LLC
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Omega Medical Research
  • Texas
    • Austin, Texas, United States, 78731
      • FutureSearch Trials of Neurology, LP
    • Baytown, Texas, United States, 77521
      • Inquest Clinical Research
    • DeSoto, Texas, United States, 75115
      • InSite Clinical Research
    • Jacksonville, Texas, United States, 32216
      • Jacksonville Center for Clinical Research
  • Virginia
    • Vienna, Virginia, United States, 22182
      • Sleep Disorders Centers of the Mid-Atlantic
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Daridorexant 10 mg; Film-coated tablets administered orally, once daily in the evening	Drug: Daridorexant 10 mg; Daridorexant 10 mg film-coated tablets
Experimental: Daridorexant 25 mg; Film-coated tablets administered orally, once daily in the evening	Drug: Daridorexant 25 mg; Daridorexant 25 mg film-coated tablets
Experimental: Daridorexant 50 mg; Film-coated tablets administered orally, once daily in the evening	Drug: Daridorexant 50 mg; Daridorexant 50 mg film-coated tablets
Placebo Comparator: Placebo; Film-coated tablets administered orally, once daily in the evening	Drug: Placebo; Matching placebo film-coated tablets
Experimental: Ex-Placebo Daridorexant 25 mg; Film-coated tablets administered orally, once daily in the evening	Drug: Daridorexant 25 mg; Daridorexant 25 mg film-coated tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Idorsia Pharmaceuticals Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2018
• Primary Completion (Actual): February 22, 2021
• Study Completion (Actual): February 22, 2021

Study Registration Dates

• First Submitted: September 19, 2018
• First Submitted That Met QC Criteria: September 20, 2018
• First Posted (Actual): September 21, 2018

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: ID-078A303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No