Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
- Conditions
- Insomnia Disorder
- Interventions
- Registration Number
- NCT03679884
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- Brief Summary
Study to assess the long term safety and tolerability of daridorexant in adult and elderly subjects suffering from difficulties to sleep
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 804
-
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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Daridorexant 50 mg Daridorexant 50 mg Film-coated tablets administered orally, once daily in the evening Ex-Placebo Daridorexant 25 mg Daridorexant 25 mg Film-coated tablets administered orally, once daily in the evening Daridorexant 25 mg Daridorexant 25 mg Film-coated tablets administered orally, once daily in the evening Daridorexant 10 mg Daridorexant 10 mg Film-coated tablets administered orally, once daily in the evening Placebo Placebo Film-coated tablets administered orally, once daily in the evening
- Primary Outcome Measures
Name Time Method Total no. of Subjects With at Least One TEAE 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. 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".
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (105)
Noble Clinical Research
🇺🇸Tucson, Arizona, United States
Preferred Research Partners, Inc
🇺🇸Little Rock, Arkansas, United States
Core Healthcare Group
🇺🇸Cerritos, California, United States
Clinical Trials Research
🇺🇸Lincoln, California, United States
Marvel Clinical Research
🇺🇸Huntington Beach, California, United States
Long Beach Clinical Trials
🇺🇸Long Beach, California, United States
Artemis Institute For Clinical Research - Riverside
🇺🇸Riverside, California, United States
Santa Monica Clinical Trials
🇺🇸Santa Monica, California, United States
Artemis Institute for Clinical Research
🇺🇸San Marcos, California, United States
Empire Clinical Research
🇺🇸Upland, California, United States
PAB Clinical Research
🇺🇸Brandon, 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
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
Clinilabs NYC
🇺🇸New York, New York, United States
Research Carolina of Hickory
🇺🇸Hickory, North Carolina, United States
Coastal Carolina Healthcare
🇺🇸New Bern, North Carolina, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Aventiv Research Inc.
🇺🇸Dublin, Ohio, United States
Cleveland Sleep Research Center
🇺🇸Middleburg Heights, Ohio, 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
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Texas, United States
InSite Clinical Research
🇺🇸DeSoto, Texas, United States
Sleep Disorders Centers of the Mid-Atlantic
🇺🇸Vienna, Virginia, United States
Hospital UZ Leuven_ Pneumology Department
🇧🇪Leuven, Belgium
Queensway Sleep Lab Sleep Clinic (MedSleep)
🇨🇦Etobicoke, Canada
Somni Research Inc.
🇨🇦Markham, Canada
CANADIAN PHASE ONWARD INC. (Toronto)
🇨🇦Toronto, Canada
Jodha Tishon Inc.
🇨🇦Toronto, Canada
Scan Sleep Specialists
🇩🇰København, Denmark
Unitutkimusyksikkö, Turun Yliopisto
🇫🇮Turku, Finland
Oivauni Oy - Kuopio
🇫🇮Kuopio, Finland
CHU NIMES - Unité de Sommeil
🇫🇷Nîmes, France
Klinische Forschung Berlin-Mitte GmbH
🇩🇪Berlin, Germany
emovis GmbH
🇩🇪Berlin, Germany
Klinik imd Poliklinik fur Neurochirurgie
🇩🇪Dresden, Germany
Klinische Forschung Hamburg GmbH
🇩🇪Hamburg, Germany
Clinical Trial Center North GmbH & Co. KG
🇩🇪Hamburg, Germany
Studienzentrum Wilhelmshöhe GmbH
🇩🇪Kassel, Germany
Synexus Leipzig Research Centre
🇩🇪Leipzig, Germany
Klinische Forschung Karlsruhe GmbH
🇩🇪Karlsruhe, 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
Magyar Honvédség Egészségügyi Központ, Neurológiai Osztály
🇭🇺Budapest, Hungary
Kinische Forschung Schwerin GmbH
🇩🇪Schwerin, Germany
ZMS Zentrum für medizinische Studien GmbH
🇩🇪Warendorf, Germany
4F Neuroimaging analysis laboratory, 56 Dalseong-ro, Jung-gu
🇰🇷Daegu, Korea, Republic of
PI-House - Centrum Badań Klinicznych
🇵🇱Gdańsk, Poland
2F Psychiatry Outpatient, 93, Jungbu-daero, Paldal-gu
🇰🇷Suwon, Korea, Republic of
EMC Instytut Medyczny SA, Przychodnia przy Łowieckiej
🇵🇱Wroclaw, Poland
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
Göteborgs Universitet, Centrum för sömn och vakenhetsstörningar
🇸🇪Göteborg, Sweden
Hospital MAZ - Neurophisiology and Sleep Department
🇪🇸Zaragoza, Spain
Sömnutredningsmottagningen, smärtcentrum Akademiska sjukhuset
🇸🇪Uppsala, Sweden
Universitetssjukhuset Örebro Neurokliniken, Sömnenheten
🇸🇪Örebro, Sweden
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Innovative Clinical Research
🇺🇸Lafayette, Colorado, United States
Acibadem City Clinic Tokuda Hospital EAD
🇧🇬Sofia, Bulgaria
Klinische Forschung Dresden GmbH
🇩🇪Dresden, Germany
Fleming Island Center for Clinical Research
🇺🇸Fleming Island, Florida, United States
Ośrodek Medycyny Study Nurseu Instytutu Psychiatrii i Neurologii (Sleep Disorders Center)
🇵🇱Warsaw, Poland
CRIUSMQ- CIUSSSCN, CETS (clinique du sommeil)
🇨🇦Quebec, Canada
MedSleep
🇨🇦Toronto, Canada
Oivauni Oy - Tampere
🇫🇮Tampere, Finland
Helene Emsellem, MD
🇺🇸Chevy Chase, Maryland, United States
St. Francis Sleep Allergy and Lung Institute
🇺🇸Clearwater, Florida, United States
St Hedwig-Krankenhaus, Klinik für Schlaf- und Chronomedizin
🇩🇪Berlin, Germany
Pulmonary Associates, Pa
🇺🇸Glendale, Arizona, United States
Canvas Clinical Research, LLC
🇺🇸Lake Worth, Florida, United States
Clinical Research Group of St. Petersburgh
🇺🇸Saint Petersburg, Florida, United States
Vitalmed Uniklinikka
🇫🇮Helsinki, Finland
Woodland International Research Group
🇺🇸Little Rock, Arkansas, United States
Clinical Research of South Florida
🇺🇸Coral Gables, Florida, United States
Research Centers of America
🇺🇸Hollywood, Florida, United States
Saltzer Clinical Research
🇺🇸Nampa, Idaho, United States
Klinische Forschung Hannover Mitte GmbH
🇩🇪Hannover, Germany
Synexus Berlin Research Centre
🇩🇪Berlin, Germany
The Medical Arts Health Research Group
🇨🇦Kelowna, Canada
Synexus Clinical Research GmbH
🇩🇪Frankfurt, Germany
Zentrum für Integrative Psychiatrie (ZiP) Universität zu Lübeck
🇩🇪Lübeck, Germany
Somnius Kft. SomnoCenter Szeged
🇭🇺Szeged, Hungary
Zentrum für Schlafmedizin Zürcher Oberland, Zürcher RehaZentrum Wald
🇨🇭Wald, Switzerland
Pulmonary Associates of the Southeast/WCR
🇺🇸Birmingham, Alabama, United States
Artemis institute for Clinical Research
🇺🇸San Diego, California, United States
Pacific Research Network
🇺🇸San Diego, California, United States
BioMed Research Institute
🇺🇸Miami, Florida, United States
Clinical Research Center of Nevada
🇺🇸Las Vegas, Nevada, United States
CTI Clinical Research II
🇺🇸Cincinnati, Ohio, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Clinical Trials of America - NC, LLC
🇺🇸Winston-Salem, North Carolina, United States
Oregon Center for Clinical Investigations,Inc
🇺🇸Salem, Oregon, United States
Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin Kompetenzzentrum Schlafmedizin
🇩🇪Berlin, Germany
Research Carolina of Huntersville
🇺🇸Huntersville, North Carolina, United States