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
1 other identifier
interventional
804
14 countries
106
Brief Summary
Study to assess the long term safety and tolerability of daridorexant in adult and elderly subjects suffering from difficulties to sleep
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2018
106 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2018
CompletedFirst Posted
Study publicly available on registry
September 21, 2018
CompletedStudy Start
First participant enrolled
October 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 22, 2021
CompletedResults Posted
Study results publicly available
March 2, 2022
CompletedMarch 2, 2022
February 1, 2022
2.4 years
September 19, 2018
January 7, 2022
February 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (5)
Daridorexant 10 mg
EXPERIMENTALFilm-coated tablets administered orally, once daily in the evening
Daridorexant 25 mg
EXPERIMENTALFilm-coated tablets administered orally, once daily in the evening
Daridorexant 50 mg
EXPERIMENTALFilm-coated tablets administered orally, once daily in the evening
Placebo
PLACEBO COMPARATORFilm-coated tablets administered orally, once daily in the evening
Ex-Placebo Daridorexant 25 mg
EXPERIMENTALFilm-coated tablets administered orally, once daily in the evening
Interventions
Daridorexant 25 mg film-coated tablets
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (106)
Pulmonary Associates of the Southeast/WCR
Birmingham, Alabama, 35243, United States
Pulmonary Associates, Pa
Glendale, Arizona, 85306, United States
Noble Clinical Research
Tucson, Arizona, 85704, United States
Preferred Research Partners, Inc
Little Rock, Arkansas, 72211, United States
Woodland International Research Group
Little Rock, Arkansas, 72211, United States
Core Healthcare Group
Cerritos, California, 90703, United States
Marvel Clinical Research
Huntington Beach, California, 92647, United States
Clinical Trials Research
Lincoln, California, 95648, United States
Long Beach Clinical Trials
Long Beach, California, 90806, United States
Artemis Institute For Clinical Research - Riverside
Riverside, California, 92503, United States
Artemis institute for Clinical Research
San Diego, California, 92103, United States
Pacific Research Network
San Diego, California, 92103, United States
Artemis Institute for Clinical Research
San Marcos, California, 92078, United States
Santa Monica Clinical Trials
Santa Monica, California, 90404, United States
Empire Clinical Research
Upland, California, 91786, United States
Innovative Clinical Research
Lafayette, Colorado, 80026, United States
PAB Clinical Research
Brandon, Florida, 33511, United States
St. Francis Sleep Allergy and Lung Institute
Clearwater, Florida, 33765, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
Fleming Island Center for Clinical Research
Fleming Island, Florida, 32003, United States
Research Centers of America
Hollywood, Florida, 33024, United States
Canvas Clinical Research, LLC
Lake Worth, Florida, 33467, United States
BioMed Research Institute
Miami, Florida, 33126, United States
Clinical Research Group of St. Petersburgh
St. Petersburg, Florida, 33707, United States
Clinical Site Partners, LLC
Winter Park, Florida, 32789, United States
Neurotrials Research Incorporated
Atlanta, Georgia, 30342, United States
Sleep Practitioners, LLC
Macon, Georgia, 31210, United States
Saltzer Clinical Research
Nampa, Idaho, 83686, United States
Helene Emsellem, MD
Chevy Chase, Maryland, 20815, United States
Sleep Disorders Center of the Mid-Atlantic
Glen Burnie, Maryland, 21061, United States
Infinity Medical Research, Inc.
North Dartmouth, Massachusetts, 02747, United States
Precise Research Centers
Flowood, Mississippi, 39232, United States
Barrett Clinic
La Vista, Nebraska, 68128, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, 89104, United States
Clinilabs NYC
New York, New York, 10019, United States
Research Carolina of Hickory
Hickory, North Carolina, 28601, United States
Research Carolina of Huntersville
Huntersville, North Carolina, 28078, United States
Coastal Carolina Healthcare
New Bern, North Carolina, 28562, United States
Wake Research Associates
Raleigh, North Carolina, 27604-1547, United States
Clinical Trials of America - NC, LLC
Winston-Salem, North Carolina, 27103, United States
CTI Clinical Research II
Cincinnati, Ohio, 45212, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45255, United States
Aventiv Research Inc.
Dublin, Ohio, 43016, United States
Cleveland Sleep Research Center
Middleburg Heights, Ohio, 44130, United States
Oregon Center for Clinical Investigations,Inc
Salem, Oregon, 97301, United States
Brian Abaluck LLC
Paoli, Pennsylvania, 19301, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
FutureSearch Trials of Neurology, LP
Austin, Texas, 78731, United States
Inquest Clinical Research
Baytown, Texas, 77521, United States
InSite Clinical Research
DeSoto, Texas, 75115, United States
Jacksonville Center for Clinical Research
Jacksonville, Texas, 32216, United States
Sleep Disorders Centers of the Mid-Atlantic
Vienna, Virginia, 22182, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
Hospital UZ Leuven_ Pneumology Department
Leuven, 3000, Belgium
Acibadem City Clinic Tokuda Hospital EAD
Sofia, 1407, Bulgaria
Queensway Sleep Lab Sleep Clinic (MedSleep)
Etobicoke, M9C 5N2, Canada
The Medical Arts Health Research Group
Kelowna, V1Y 3G8, Canada
Somni Research Inc.
Markham, L3R 1A3, Canada
CRIUSMQ- CIUSSSCN, CETS (clinique du sommeil)
Québec, G1J 2G2, Canada
CANADIAN PHASE ONWARD INC. (Toronto)
Toronto, M3J 0K2, Canada
MedSleep
Toronto, M4P 1P2, Canada
Jodha Tishon Inc.
Toronto, M5G1N8, Canada
Scan Sleep Specialists
Copenhagen, 1053, Denmark
Vitalmed Uniklinikka
Helsinki, 380, Finland
Oivauni Oy - Kuopio
Kuopio, 70100, Finland
Oivauni Oy - Tampere
Tampere, Finland
Unitutkimusyksikkö, Turun Yliopisto
Turku, Finland
CHU NIMES - Unité de Sommeil
Nîmes, 30029, France
St Hedwig-Krankenhaus, Klinik für Schlaf- und Chronomedizin
Berlin, 10115, Germany
Klinische Forschung Berlin-Mitte GmbH
Berlin, 10117, Germany
emovis GmbH
Berlin, 10629, Germany
Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin Kompetenzzentrum Schlafmedizin
Berlin, 12200, Germany
Synexus Berlin Research Centre
Berlin, 12627, Germany
Synexus Clinical Research GmbH
Bochum, 44787, Germany
Klinische Forschung Dresden GmbH
Dresden, 1069, Germany
Klinik imd Poliklinik fur Neurochirurgie
Dresden, 1307, Germany
Synexus Clinical Research GmbH
Frankfurt, 60313, Germany
Clinical Trial Center North GmbH & Co. KG
Hamburg, 20251, Germany
Klinische Forschung Hamburg GmbH
Hamburg, 20253, Germany
Klinische Forschung Hannover Mitte GmbH
Hanover, 30159, Germany
Klinische Forschung Karlsruhe GmbH
Karlsruhe, 76137, Germany
Studienzentrum Wilhelmshöhe GmbH
Kassel, 34131, Germany
Synexus Leipzig Research Centre
Leipzig, 4103, Germany
Zentrum für Integrative Psychiatrie (ZiP) Universität zu Lübeck
Lübeck, 23538, Germany
Central Insitute of Mental Health Sleep laboratory Medical Faculty Mannheim/Heidelberg University
Mannheim, 68159, Germany
Klinikum Rechts der lsar TU München Dept. of Psychiatry and Psychotherapy
München, 81675, Germany
Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie der Universität am Bezirksklinikum Regensburg
Regensburg, 93053, Germany
SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
Schwerin, 19053, Germany
Kinische Forschung Schwerin GmbH
Schwerin, 19055, Germany
ZMS Zentrum für medizinische Studien GmbH
Warendorf, 48231, Germany
Magyar Honvédség Egészségügyi Központ, Neurológiai Osztály
Budapest, 1134, Hungary
Somnius Kft. SomnoCenter Szeged
Szeged, 6725, Hungary
PI-House - Centrum Badań Klinicznych
Gdansk, 80-546, Poland
Ośrodek Medycyny Study Nurseu Instytutu Psychiatrii i Neurologii (Sleep Disorders Center)
Warsaw, 02-957, Poland
EMC Instytut Medyczny SA, Przychodnia przy Łowieckiej
Wroclaw, 50220, Poland
4F Neuroimaging analysis laboratory, 56 Dalseong-ro, Jung-gu
Daegu, 41931, South Korea
2F Psychiatry Outpatient, 93, Jungbu-daero, Paldal-gu
Suwon, 16247, South Korea
Centro Médico Teknon - Medicina del Sueño
Barcelona, 8017, Spain
Hospital Universitari Vall d'Hebron - Neurophisiology Deparment - Sleep Unit
Barcelona, 8035, Spain
Instituto de Investigaciones del Sueno
Madrid, 28036, Spain
Hospital Universitario Araba - Unidad Funcional de Trastornos del Sueño
Vitoria-Gasteiz, 1004, Spain
Hospital MAZ - Neurophisiology and Sleep Department
Zaragoza, 50015, Spain
Göteborgs Universitet, Centrum för sömn och vakenhetsstörningar
Gothenburg, 41390, Sweden
Universitetssjukhuset Örebro Neurokliniken, Sömnenheten
Örebro, 70185, Sweden
Sömnutredningsmottagningen, smärtcentrum Akademiska sjukhuset
Uppsala, 75185, Sweden
Zentrum für Schlafmedizin Zürcher Oberland, Zürcher RehaZentrum Wald
Wald, 8636, Switzerland
Related Publications (2)
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.
PMID: 37526060DERIVEDKunz 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.
PMID: 36484969DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Disclosure Desk
- Organization
- Idorsia Pharmaceuticals Ltd
Study Officials
- STUDY DIRECTOR
Clinical Trials
Idorsia Pharmaceuticals Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2018
First Posted
September 21, 2018
Study Start
October 9, 2018
Primary Completion
February 22, 2021
Study Completion
February 22, 2021
Last Updated
March 2, 2022
Results First Posted
March 2, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share