Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
- Registration Number
- NCT03575104
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 924
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Daridorexant 25 mg Daridorexant - Daridorexant 10 mg Daridorexant -
- Primary Outcome Measures
Name Time Method Change From Baseline to Month 1 in Latency to Persistent Sleep (LPS) (Sleep Onset) From baseline to Month 1 (i.e. for up to 1 month) "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.
Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance) From baseline to Month 1 (i.e. for up to 1 month) "Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.
Change From Baseline to Month 3 in Latency to Persistent Sleep (LPS) From baseline to Month 3 (i.e. for up to 3 months) "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.
Change From Baseline to Month 3 in Wake After Sleep Onset (WASO) From baseline to Month 3 (i.e. for up to 3 months) "Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.
- Secondary Outcome Measures
Name Time Method 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) "Subjective Total Sleep Time" is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in the subjective Total Sleep Time. A negative change from baseline indicates a decrease in subjective Total Sleep Time.
Change From Baseline to Month 3 in IDSIQ Sleepiness Domain Score From baseline to Month 3 (i.e. for up to 3 months) The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a validated patient reported outcome instrument comprising 14 items (each using a numeric rating scale from 0 to 10) grouped into three domains (i.e., sleepiness, mood, and alert/cognition) reflecting daytime impairment of insomnia. The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
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) Subjective Total Sleep Time is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in the subjective Total Sleep Time. A negative change from baseline indicates a decrease in subjective Total Sleep Time.
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) The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a validated patient reported outcome instrument comprising 14 items (each using a numeric rating scale from 0 to 10) grouped into three domains (i.e., sleepiness, mood, and alert/cognition) reflecting daytime impairment of insomnia. The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Trial Locations
- Locations (85)
Canadian Phase Onward Inc.
🇨🇦Toronto, Ontario, Canada
FutureSearch Trials of Neurology, LP
🇺🇸Austin, Texas, United States
Neurotrials Research Incorporated
🇺🇸Atlanta, Georgia, United States
Baptist Health Center for Clinical Research
🇺🇸Little Rock, Arkansas, United States
Precise Research Centers
🇺🇸Flowood, Mississippi, United States
Pacific Research Network
🇺🇸San Diego, California, United States
CTI Clinical Research II
🇺🇸Cincinnati, Ohio, United States
Hospital Universitair Zieknhuis Brussel, Pneumology and Sleep Laboratory
🇧🇪Brussels, Belgium
University Hospital Gent, Department of General Internal Medicine and Center of neurophysiological Monitoring
🇧🇪Gent, Belgium
Unitutkimusyksikkö, Turun Yliopisto
🇫🇮Turku, Finland
CHRU De Lille - Hospital Salengro - Neurophysiologie Clinique
🇫🇷Lille, France
Advanced Sleep Research GmbH
🇩🇪Berlin, Germany
Klinische Forschung Berlin-Mitte GmbH
🇩🇪Berlin, Germany
Synexus Clinical Research GmbH
🇩🇪Frankfurt, Germany
Santa Monica Clinical Trials
🇺🇸Santa Monica, California, United States
Rowe Neurology Institute
🇺🇸Lenexa, Kansas, United States
Innovative Clinical Research
🇺🇸Lafayette, Colorado, United States
Clinical Trials of America - NC, LLC
🇺🇸Winston-Salem, North Carolina, United States
Core Healthcare Group
🇺🇸Cerritos, California, United States
Pulmonary Associates, Pa
🇺🇸Glendale, Arizona, United States
Noble Clinical Research
🇺🇸Tucson, Arizona, United States
Woodland International Research Group
🇺🇸Little Rock, Arkansas, United States
Artemis Institute for Clinical Research
🇺🇸San Marcos, California, United States
Artemis Institute For Clinical Research - Riverside
🇺🇸Riverside, California, United States
Empire Clinical Research
🇺🇸Upland, California, United States
Clinical Research of South Florida
🇺🇸Coral Gables, Florida, United States
Clinical Trials Research
🇺🇸Lincoln, Florida, United States
Fleming Island Center for Clinical Research
🇺🇸Fleming Island, Florida, United States
Clinical Research Group of St. Petersburgh
🇺🇸Saint Petersburg, Florida, United States
Sleep Practitioners, LLC
🇺🇸Macon, Georgia, United States
Saltzer Clinical Research
🇺🇸Nampa, Idaho, United States
Sleep Disorders Center of the Mid-Atlantic
🇺🇸Glen Burnie, Maryland, United States
Neurocare Inc.
🇺🇸Newton, Massachusetts, United States
Research Carolina of Hickory
🇺🇸Hickory, North Carolina, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Ohio Sleep Medicine Institue
🇺🇸Dublin, Ohio, United States
Cleveland Sleep Research Center
🇺🇸Middleburg Heights, Ohio, United States
Robert V. Sibilia, MD, Inc.
🇺🇸Wooster, Ohio, United States
Brian Abaluck LLC
🇺🇸Paoli, Pennsylvania, United States
Wesley Neurology Clinic Pc (Multiple Sclerosis)
🇺🇸Cordova, Tennessee, United States
InSite Clinical Research
🇺🇸DeSoto, Texas, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Texas, United States
Dm Clinical Research / Martin Diagnostic Clinic
🇺🇸Tomball, Texas, United States
HOSPITAL AZ SINT-JAN_Neurology department
🇧🇪Brugge, Belgium
Hospital UZ Leuven_ Pneumology Department
🇧🇪Leuven, Belgium
Narodni Ustav Dusevniho Zdravi (National Institute of Mental Health)
🇨🇿Klecany, Czechia
Acibadem City Clinic Tokuda Hospital EAD
🇧🇬Sofia, Bulgaria
The Medical Arts Health Research Group
🇨🇦Kelowna, Canada
Somni Research Inc.
🇨🇦Markham, Canada
Queensway Sleep Lab Sleep Clinic (MedSleep)- 5359 Dundas Street West, Suite 202, Etobicoke, ON M9B 1B1
🇨🇦Etobicoke, Canada
Somni Research, Calgary
🇨🇦Toronto, Canada
CANADIAN PHASE ONWARD INC. (Toronto)
🇨🇦Toronto, Canada
Nemocnice České Budějovice, Centrum pro poruchy spánku a spánkovou medicínu
🇨🇿České Budějovice, Czechia
Fakultní nemocnice Ostrava, Spánková laboratoř
🇨🇿Ostrava-Poruba, Czechia
Vitalmed Uniklinikka
🇫🇮Helsinki, Finland
Oivauni Oy - Kuopio
🇫🇮Kuopio, Finland
Oivauni Oy - Tampere
🇫🇮Tampere, Finland
Clinique beau soleil - Department Sleep and Neurology
🇫🇷Montpellier, France
CHU NIMES - Unité de Sommeil
🇫🇷Nîmes, France
Klinische Forschung Dresden GmbH
🇩🇪Dresden, Germany
Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin Kompetenzzentrum Schlafmedizin
🇩🇪Berlin, Germany
Interdisziplinäre Schlafmedizin, Pfalzklinikum
🇩🇪Klingenmünster, Germany
Klinische Forschung Hannover Mitte GmbH
🇩🇪Hannover, 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
Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie der Universität am Bezirksklinikum Regensburg
🇩🇪Regensburg, Germany
4F Neuroimaging analysis laboratory, 56 Dalseong-ro, Jung-gu
🇰🇷Daegu, Korea, Republic of
Magyar Honvédség Egészségügyi Központ, Neurológiai Osztály
🇭🇺Budapest, Hungary
SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
🇩🇪Schwerin, Germany
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Somnius Kft. SomnoCenter Szeged
🇭🇺Szeged, Hungary
3F, 2nd Building, Psychiatry Outpatient, Family Counseling Room, 42 Jebong-ro, Donggu
🇰🇷Gwangju, Korea, Republic of
8F Sleep Lab, 1st Building,82, Gumi-ro 173 Beon-gil, Bundang-gu
🇰🇷Seongnam, Korea, Republic of
B1F Neurological examination room, 892 Dongnam-ro, Gangdong-gu
🇰🇷Seoul, Korea, Republic of
B2F, Clinical Trial Center, Konkuk University Medical Center 120-1, Neungdong-ro, Gwangjin-gu
🇰🇷Seoul, Korea, Republic of
SOPHIAHEMMET (Stockholm)
🇸🇪Stockholm, Sweden
2F Psychiatry Outpatient, 93, Jungbu-daero, Paldal-gu
🇰🇷Suwon, Korea, Republic of
Göteborgs Universitet, Centrum för sömn och vakenhetsstörningar
🇸🇪Göteborg, Sweden
Sömnutredningsmottagningen, smärtcentrum Akademiska sjukhuset
🇸🇪Uppsala, Sweden
Universitetssjukhuset Örebro Neurokliniken, Sömnenheten
🇸🇪Örebro, Sweden
3F Sleep Medicine Center, 101 Daehak-Ro Jongno-Gu
🇰🇷Seoul, Korea, Republic of
1st CRC room, 2F, Jejoong building, 50-1 Yonsei-ro,, Seodaemun-gu
🇰🇷Seoul, Korea, Republic of
Hawaii Pacific Neurosciences
🇺🇸Honolulu, Hawaii, United States
Garden City Asthma and Sleep Center
🇺🇸Garden City, New York, United States