--- title: Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep nct_id: NCT03575104 overall_status: COMPLETED phase: PHASE3 sponsor: Idorsia Pharmaceuticals Ltd. study_type: INTERVENTIONAL primary_condition: Insomnia Disorder countries: United States, Belgium, Bulgaria, Canada, Czechia, Finland, France, Germany, Hungary, South Korea, Sweden canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03575104.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03575104" ct_last_update_post_date: 2022-03-25 last_seen_at: "2026-05-12T06:41:05.685Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep **Official Title:** 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 **NCT ID:** [NCT03575104](https://clinicaltrials.gov/study/NCT03575104) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 924 - **Lead Sponsor:** Idorsia Pharmaceuticals Ltd. - **Conditions:** Insomnia Disorder - **Start Date:** 2018-05-29 - **Completion Date:** 2020-05-14 - **CT.gov Last Update:** 2022-03-25 ## 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. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: * 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. Exclusion Criteria: * 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. ``` ## Arms - **Daridorexant 10 mg** (EXPERIMENTAL) - **Daridorexant 25 mg** (EXPERIMENTAL) - **Placebo** (PLACEBO_COMPARATOR) ## Interventions - **Daridorexant** (DRUG) — Daridorexant will be administered as tablets, orally, once daily in the evening. - **Placebo** (OTHER) — Matching placebo will be administered as tablets, orally, once daily in the evening. ## Primary Outcomes - **Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance)** _(time frame: 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 Wake After Sleep Onset (WASO)** _(time frame: 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. - **Change From Baseline to Month 1 in Latency to Persistent Sleep (LPS) (Sleep Onset)** _(time frame: 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 3 in Latency to Persistent Sleep (LPS)** _(time frame: 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. ## Secondary Outcomes - **Change From Baseline to Month 1 in the Subjective Total Sleep Time (sTST)** _(time frame: 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)** _(time frame: 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** _(time frame: From baseline to Month 1 (i.e. for up to 1 month))_ - **Change From Baseline to Month 3 in IDSIQ Sleepiness Domain Score** _(time frame: From baseline to Month 3 (i.e. for up to 3 months))_ ## Locations (86) - Pulmonary Associates, Pa, Glendale, Arizona, United States - Noble Clinical Research, Tucson, Arizona, United States - Baptist Health Center for Clinical Research, Little Rock, Arkansas, United States - Woodland International Research Group, Little Rock, Arkansas, United States - Core Healthcare Group, Cerritos, California, United States - Artemis Institute For Clinical Research - Riverside, Riverside, California, United States - Pacific Research Network, San Diego, California, United States - Artemis Institute for Clinical Research, San Marcos, California, United States - Santa Monica Clinical Trials, Santa Monica, California, United States - Empire Clinical Research, Upland, California, United States - Innovative Clinical Research, Lafayette, Colorado, United States - Clinical Research of South Florida, Coral Gables, Florida, United States - Fleming Island Center for Clinical Research, Fleming Island, Florida, United States - Clinical Trials Research, Lincoln, Florida, United States - Clinical Research Group of St. Petersburgh, St. Petersburg, Florida, United States - Neurotrials Research Incorporated, Atlanta, Georgia, United States - Sleep Practitioners, LLC, Macon, Georgia, United States - Hawaii Pacific Neurosciences, Honolulu, Hawaii, United States - Saltzer Clinical Research, Nampa, Idaho, United States - Rowe Neurology Institute, Lenexa, Kansas, United States - Sleep Disorders Center of the Mid-Atlantic, Glen Burnie, Maryland, United States - Neurocare Inc., Newton, Massachusetts, United States - Precise Research Centers, Flowood, Mississippi, United States - Garden City Asthma and Sleep Center, Garden City, New York, United States - Research Carolina of Hickory, Hickory, North Carolina, United States - Wake Research Associates, Raleigh, North Carolina, United States - Clinical Trials of America - NC, LLC, Winston-Salem, North Carolina, United States - CTI Clinical Research II, Cincinnati, Ohio, 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 - FutureSearch Trials of Neurology, LP, Austin, Texas, 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, Bruges, Belgium - Hospital Universitair Zieknhuis Brussel, Pneumology and Sleep Laboratory, Brussels, Belgium - University Hospital Gent, Department of General Internal Medicine and Center of neurophysiological Monitoring, Ghent, Belgium - Hospital UZ Leuven_ Pneumology Department, Leuven, Belgium - Acibadem City Clinic Tokuda Hospital EAD, Sofia, Bulgaria - Canadian Phase Onward Inc., Toronto, Ontario, Canada - Queensway Sleep Lab Sleep Clinic (MedSleep)- 5359 Dundas Street West, Suite 202, Etobicoke, ON M9B 1B1, Etobicoke, Canada - The Medical Arts Health Research Group, Kelowna, Canada - Somni Research Inc., Markham, 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 - Narodni Ustav Dusevniho Zdravi (National Institute of Mental Health), Klecany, Czechia - Fakultní nemocnice Ostrava, Spánková laboratoř, Ostrava-Poruba, Czechia - Vitalmed Uniklinikka, Helsinki, Finland - Oivauni Oy - Kuopio, Kuopio, Finland - Oivauni Oy - Tampere, Tampere, Finland - Unitutkimusyksikkö, Turun Yliopisto, Turku, Finland - CHRU De Lille - Hospital Salengro - Neurophysiologie Clinique, Lille, France - Clinique beau soleil - Department Sleep and Neurology, Montpellier, France - CHU NIMES - Unité de Sommeil, Nîmes, France - Advanced Sleep Research GmbH, Berlin, Germany - Klinische Forschung Berlin-Mitte GmbH, Berlin, Germany - Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin Kompetenzzentrum Schlafmedizin, Berlin, Germany - Synexus Clinical Research GmbH, Bochum, Germany - Klinische Forschung Dresden GmbH, Dresden, Germany - Synexus Clinical Research GmbH, Frankfurt, Germany - Klinische Forschung Hannover Mitte GmbH, Hanover, Germany - Interdisziplinäre Schlafmedizin, Pfalzklinikum, Klingenmünster, 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 - SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH, Schwerin, Germany - Magyar Honvédség Egészségügyi Központ, Neurológiai Osztály, Budapest, Hungary - Somnius Kft. SomnoCenter Szeged, Szeged, Hungary - Dong-A University Hospital, Busan, South Korea - 4F Neuroimaging analysis laboratory, 56 Dalseong-ro, Jung-gu, Daegu, South Korea - Chungnam National University Hospital, Daejeon, South Korea - 3F, 2nd Building, Psychiatry Outpatient, Family Counseling Room, 42 Jebong-ro, Donggu, Gwangju, South Korea - 8F Sleep Lab, 1st Building,82, Gumi-ro 173 Beon-gil, Bundang-gu, Seongnam, South Korea - 3F Sleep Medicine Center, 101 Daehak-Ro Jongno-Gu, Seoul, South Korea - 1st CRC room, 2F, Jejoong building, 50-1 Yonsei-ro,, Seodaemun-gu, Seoul, South Korea - B2F, Clinical Trial Center, Konkuk University Medical Center 120-1, Neungdong-ro, Gwangjin-gu, Seoul, South Korea - B1F Neurological examination room, 892 Dongnam-ro, Gangdong-gu, Seoul, South Korea - 2F Psychiatry Outpatient, 93, Jungbu-daero, Paldal-gu, Suwon, South Korea - Göteborgs Universitet, Centrum för sömn och vakenhetsstörningar, Gothenburg, Sweden - Universitetssjukhuset Örebro Neurokliniken, Sömnenheten, Örebro, Sweden - SOPHIAHEMMET (Stockholm), Stockholm, Sweden - Sömnutredningsmottagningen, smärtcentrum Akademiska sjukhuset, Uppsala, Sweden ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.pulmonary associates, pa|glendale|arizona|united states` — added _(2026-05-12)_ - `locations.noble clinical research|tucson|arizona|united states` — added _(2026-05-12)_ - `locations.baptist health center for clinical research|little rock|arkansas|united states` — added _(2026-05-12)_ - `locations.woodland international research group|little rock|arkansas|united states` — added _(2026-05-12)_ - `locations.core healthcare group|cerritos|california|united states` — added _(2026-05-12)_ - `locations.artemis institute for clinical research - riverside|riverside|california|united states` — added _(2026-05-12)_ - `locations.pacific research network|san diego|california|united states` — added _(2026-05-12)_ - `locations.artemis institute for clinical research|san marcos|california|united states` — added _(2026-05-12)_ - `locations.santa monica clinical trials|santa monica|california|united states` — added _(2026-05-12)_ - `locations.empire clinical research|upland|california|united states` — added _(2026-05-12)_ - `locations.innovative clinical research|lafayette|colorado|united states` — added _(2026-05-12)_ - `locations.clinical research of south florida|coral gables|florida|united states` — added _(2026-05-12)_ - `locations.fleming island center for clinical research|fleming island|florida|united states` — added _(2026-05-12)_ - `locations.clinical trials research|lincoln|florida|united states` — added _(2026-05-12)_ - `locations.clinical research group of st. petersburgh|st. petersburg|florida|united states` — added _(2026-05-12)_ - `locations.neurotrials research incorporated|atlanta|georgia|united states` — added _(2026-05-12)_ - `locations.sleep practitioners, llc|macon|georgia|united states` — added _(2026-05-12)_ - `locations.hawaii pacific neurosciences|honolulu|hawaii|united states` — added _(2026-05-12)_ - `locations.saltzer clinical research|nampa|idaho|united states` — added _(2026-05-12)_ - `locations.rowe neurology institute|lenexa|kansas|united states` — added _(2026-05-12)_ - `locations.sleep disorders center of the mid-atlantic|glen burnie|maryland|united states` — added _(2026-05-12)_ - `locations.neurocare inc.|newton|massachusetts|united states` — added _(2026-05-12)_ - `locations.precise research centers|flowood|mississippi|united states` — added _(2026-05-12)_ - `locations.garden city asthma and sleep center|garden city|new york|united states` — added _(2026-05-12)_ - `locations.research carolina of hickory|hickory|north carolina|united states` — added _(2026-05-12)_ - `locations.wake research associates|raleigh|north carolina|united states` — added _(2026-05-12)_ - `locations.oivauni oy - kuopio|kuopio||finland` — added _(2026-05-12)_ - `locations.clinical trials of america - nc, llc|winston-salem|north carolina|united states` — added _(2026-05-12)_ - `locations.cti clinical research ii|cincinnati|ohio|united states` — added _(2026-05-12)_ - `locations.ohio sleep medicine institue|dublin|ohio|united states` — added _(2026-05-12)_ - `locations.cleveland sleep research center|middleburg heights|ohio|united states` — added _(2026-05-12)_ - `locations.robert v. sibilia, md, inc.|wooster|ohio|united states` — added _(2026-05-12)_ - `locations.brian abaluck llc|paoli|pennsylvania|united states` — added _(2026-05-12)_ - `locations.wesley neurology clinic pc (multiple sclerosis)|cordova|tennessee|united states` — added _(2026-05-12)_ - `locations.futuresearch trials of neurology, lp|austin|texas|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT03575104.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT03575104* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*