Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Polysomnography Study to Assess the Efficacy and Safety of ACT-541468 in Adult and Elderly Subjects With Insomnia Disorder
1 other identifier
interventional
924
11 countries
86
Brief Summary
The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2018
86 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
May 17, 2018
CompletedStudy Start
First participant enrolled
May 29, 2018
CompletedFirst Posted
Study publicly available on registry
July 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 14, 2020
CompletedResults Posted
Study results publicly available
March 25, 2022
CompletedMarch 25, 2022
March 1, 2022
1.9 years
May 17, 2018
January 7, 2022
March 24, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance)
"Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.
From baseline to Month 1 (i.e. for up to 1 month)
Change From Baseline to Month 3 in Wake After Sleep Onset (WASO)
"Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.
From baseline to Month 3 (i.e. for up to 3 months)
Change From Baseline to Month 1 in Latency to Persistent Sleep (LPS) (Sleep Onset)
"Latency to Persistent Sleep" is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-awake, i.e., epochs scored as either sleep stage 1 (S1), sleep stage 2 (S2), sleep stage 3 (slow wave sleep) or REM, as determined by polysomnography.
From baseline to Month 1 (i.e. for up to 1 month)
Change From Baseline to Month 3 in Latency to Persistent Sleep (LPS)
"Latency to Persistent Sleep" is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-awake, i.e., epochs scored as either sleep stage 1 (S1), sleep stage 2 (S2), sleep stage 3 (slow wave sleep) or REM, as determined by polysomnography.
From baseline to Month 3 (i.e. for up to 3 months)
Secondary Outcomes (4)
Change From Baseline to Month 1 in the Subjective Total Sleep Time (sTST)
From baseline to Month 1 (i.e. for up to 1 month)
Change From Baseline to Month 3 in the Subjective Total Sleep Time (sTST)
From baseline to Month 3 (i.e. for up to 3 months)
Change From Baseline to Month 1 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Sleepiness Domain Score
From baseline to Month 1 (i.e. for up to 1 month)
Change From Baseline to Month 3 in IDSIQ Sleepiness Domain Score
From baseline to Month 3 (i.e. for up to 3 months)
Study Arms (3)
Daridorexant 10 mg
EXPERIMENTALDaridorexant 25 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Daridorexant will be administered as tablets, orally, once daily in the evening.
Matching placebo will be administered as tablets, orally, once daily in the evening.
Eligibility Criteria
You may qualify if:
- Signed informed consent prior to any study-mandated procedure;
- Male or female aged ≥ 18 years;
- Insomnia disorder according to DSM-5 criteria;
- Insomnia Severity Index score ≥ 15;
- Insufficient sleep quantity as collected subjectively in the sleep diary and validated objectively by polysomnography;
- Women of childbearing potential must have a negative and urine pregnancy test and use the contraception scheme up to at least 30 days after last study treatment intake.
You may not qualify if:
- Body mass index below 18.5 or above 40.0 kg/m2;
- Any lifetime history of of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, narcolepsy, or apnea/hypopnea;
- Cognitive behavioral therapy (CBT) only allowed if, the treatment started at least 1 month prior to Visit 3 and the subject agrees to continue this CBT throughout the study;
- Self-reported usual daytime napping ≥ 1 hour per day and ≥ 3 days per week;
- Acute or unstable psychiatric conditions diagnosed by the Mini International Neuropsychiatric Interview;
- Mini Mental State Examination (MMSE) score \< 25 in subjects ≥ 50 years;
- For female subjects: pregnant, lactating or planning to become pregnant during projected duration of the study;
- History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (86)
Pulmonary Associates, Pa
Glendale, Arizona, 85306, United States
Noble Clinical Research
Tucson, Arizona, 85704, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205, United States
Woodland International Research Group
Little Rock, Arkansas, 72211, United States
Core Healthcare Group
Cerritos, California, 90703, United States
Artemis Institute For Clinical Research - Riverside
Riverside, California, 92503, 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
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
Fleming Island Center for Clinical Research
Fleming Island, Florida, 32003, United States
Clinical Trials Research
Lincoln, Florida, 95648, United States
Clinical Research Group of St. Petersburgh
St. Petersburg, Florida, 33707, United States
Neurotrials Research Incorporated
Atlanta, Georgia, 30342, United States
Sleep Practitioners, LLC
Macon, Georgia, 31210, United States
Hawaii Pacific Neurosciences
Honolulu, Hawaii, 96817, United States
Saltzer Clinical Research
Nampa, Idaho, 83686, United States
Rowe Neurology Institute
Lenexa, Kansas, 66214, United States
Sleep Disorders Center of the Mid-Atlantic
Glen Burnie, Maryland, 21061, United States
Neurocare Inc.
Newton, Massachusetts, 02459, United States
Precise Research Centers
Flowood, Mississippi, 39232, United States
Garden City Asthma and Sleep Center
Garden City, New York, 11530, United States
Research Carolina of Hickory
Hickory, North Carolina, 28601, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Clinical Trials of America - NC, LLC
Winston-Salem, North Carolina, 27103, United States
CTI Clinical Research II
Cincinnati, Ohio, 45212, United States
Ohio Sleep Medicine Institue
Dublin, Ohio, 43017, United States
Cleveland Sleep Research Center
Middleburg Heights, Ohio, 44130, United States
Robert V. Sibilia, MD, Inc.
Wooster, Ohio, 44691, United States
Brian Abaluck LLC
Paoli, Pennsylvania, 19301, United States
Wesley Neurology Clinic Pc (Multiple Sclerosis)
Cordova, Tennessee, 38018, United States
FutureSearch Trials of Neurology, LP
Austin, Texas, 78731, United States
InSite Clinical Research
DeSoto, Texas, 75115, United States
Jacksonville Center for Clinical Research
Jacksonville, Texas, 32216, United States
Dm Clinical Research / Martin Diagnostic Clinic
Tomball, Texas, 77375, United States
HOSPITAL AZ SINT-JAN_Neurology department
Bruges, 8000, Belgium
Hospital Universitair Zieknhuis Brussel, Pneumology and Sleep Laboratory
Brussels, 1090, Belgium
University Hospital Gent, Department of General Internal Medicine and Center of neurophysiological Monitoring
Ghent, 9000, Belgium
Hospital UZ Leuven_ Pneumology Department
Leuven, 3000, Belgium
Acibadem City Clinic Tokuda Hospital EAD
Sofia, 1407, Bulgaria
Canadian Phase Onward Inc.
Toronto, Ontario, M3J 2C5, Canada
Queensway Sleep Lab Sleep Clinic (MedSleep)- 5359 Dundas Street West, Suite 202, Etobicoke, ON M9B 1B1
Etobicoke, M9C 5N2, Canada
The Medical Arts Health Research Group
Kelowna, V1Y 3G8, Canada
Somni Research Inc.
Markham, L3R 1A3, Canada
Somni Research, Calgary
Toronto, M3H 3W1, Canada
CANADIAN PHASE ONWARD INC. (Toronto)
Toronto, M3J 0K2, Canada
Nemocnice České Budějovice, Centrum pro poruchy spánku a spánkovou medicínu
České Budějovice, 37087, Czechia
Narodni Ustav Dusevniho Zdravi (National Institute of Mental Health)
Klecany, Czechia
Fakultní nemocnice Ostrava, Spánková laboratoř
Ostrava-Poruba, 70852, Czechia
Vitalmed Uniklinikka
Helsinki, 380, Finland
Oivauni Oy - Kuopio
Kuopio, 70100, Finland
Oivauni Oy - Tampere
Tampere, Finland
Unitutkimusyksikkö, Turun Yliopisto
Turku, Finland
CHRU De Lille - Hospital Salengro - Neurophysiologie Clinique
Lille, 59037, France
Clinique beau soleil - Department Sleep and Neurology
Montpellier, France
CHU NIMES - Unité de Sommeil
Nîmes, 30029, France
Advanced Sleep Research GmbH
Berlin, 10117, Germany
Klinische Forschung Berlin-Mitte GmbH
Berlin, 10117, Germany
Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin Kompetenzzentrum Schlafmedizin
Berlin, 12200, Germany
Synexus Clinical Research GmbH
Bochum, 44787, Germany
Klinische Forschung Dresden GmbH
Dresden, 1069, Germany
Synexus Clinical Research GmbH
Frankfurt, 60313, Germany
Klinische Forschung Hannover Mitte GmbH
Hanover, 30159, Germany
Interdisziplinäre Schlafmedizin, Pfalzklinikum
Klingenmünster, 76889, 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
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
Magyar Honvédség Egészségügyi Központ, Neurológiai Osztály
Budapest, 1134, Hungary
Somnius Kft. SomnoCenter Szeged
Szeged, 6725, Hungary
Dong-A University Hospital
Busan, 49201, South Korea
4F Neuroimaging analysis laboratory, 56 Dalseong-ro, Jung-gu
Daegu, 41931, South Korea
Chungnam National University Hospital
Daejeon, 35015, South Korea
3F, 2nd Building, Psychiatry Outpatient, Family Counseling Room, 42 Jebong-ro, Donggu
Gwangju, 61469, South Korea
8F Sleep Lab, 1st Building,82, Gumi-ro 173 Beon-gil, Bundang-gu
Seongnam, 13620, South Korea
3F Sleep Medicine Center, 101 Daehak-Ro Jongno-Gu
Seoul, 3080, South Korea
1st CRC room, 2F, Jejoong building, 50-1 Yonsei-ro,, Seodaemun-gu
Seoul, 3722, South Korea
B2F, Clinical Trial Center, Konkuk University Medical Center 120-1, Neungdong-ro, Gwangjin-gu
Seoul, 5030, South Korea
B1F Neurological examination room, 892 Dongnam-ro, Gangdong-gu
Seoul, 5278, South Korea
2F Psychiatry Outpatient, 93, Jungbu-daero, Paldal-gu
Suwon, 16247, South Korea
Göteborgs Universitet, Centrum för sömn och vakenhetsstörningar
Gothenburg, 41390, Sweden
Universitetssjukhuset Örebro Neurokliniken, Sömnenheten
Örebro, 70185, Sweden
SOPHIAHEMMET (Stockholm)
Stockholm, 11486, Sweden
Sömnutredningsmottagningen, smärtcentrum Akademiska sjukhuset
Uppsala, 75185, Sweden
Related Publications (6)
Hudgens S, Phillips-Beyer A, Newton L, Seboek Kinter D, Benes H. Development and Validation of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). Patient. 2021 Mar;14(2):249-268. doi: 10.1007/s40271-020-00474-z. Epub 2020 Nov 1.
PMID: 33131027BACKGROUNDMignot E, Mayleben D, Fietze I, Leger D, Zammit G, Bassetti CLA, Pain S, Kinter DS, Roth T; investigators. Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo-controlled, phase 3 trials. Lancet Neurol. 2022 Feb;21(2):125-139. doi: 10.1016/S1474-4422(21)00436-1.
PMID: 35065036RESULTDi Marco T, Djonlagic I, Dauvilliers Y, Sadeghi K, Little D, Datta AN, Hubbard J, Hajak G, Krystal A, Olivieri A, Parrino L, Puryear CB, Zammit G, Donoghue J, Scammell TE. Effect of daridorexant on sleep architecture in patients with chronic insomnia disorder: a pooled post hoc analysis of two randomized phase 3 clinical studies. Sleep. 2024 Nov 8;47(11):zsae098. doi: 10.1093/sleep/zsae098.
PMID: 38644625DERIVEDCitrome L, Juday TR, Lundwall C. Lemborexant and Daridorexant for the Treatment of Insomnia: An Indirect Comparison Using Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed. J Clin Psychiatry. 2023 Oct 2;84(6):23m14851. doi: 10.4088/JCP.23m14851.
PMID: 37796657DERIVEDDutta 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: 37526060DERIVEDHeidenreich S, Ross M, Chua GN, Seboek Kinter D, Phillips-Beyer A. Preferences of patients for benefits and risks of insomnia medications using data elicited during two phase III clinical trials. Sleep. 2022 Nov 9;45(11):zsac204. doi: 10.1093/sleep/zsac204.
PMID: 36054921DERIVED
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
May 17, 2018
First Posted
July 2, 2018
Study Start
May 29, 2018
Primary Completion
April 9, 2020
Study Completion
May 14, 2020
Last Updated
March 25, 2022
Results First Posted
March 25, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share