Insomnia DisorderPhase 3NCT03575104
Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
A Phase 3 study testing Daridorexant in people with Insomnia Disorder, run by Idorsia Pharmaceuticals Ltd. at 86 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia Disorder
- What is being tested?
- Daridorexant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 924 participants
- Where
- 86 sitesin 11 countries
- Study dates
- 29 May 2018to 14 May 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- 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.
Trial locations and contacts
86 sites in 11 countries.
86 sites in 11 countries
United States37 sites
Neurotrials Research Incorporated
Atlanta, Georgia, 30342
FutureSearch Trials of Neurology, LP
Austin, Texas, 78731
Core Healthcare Group
Cerritos, California, 90703
CTI Clinical Research II
Cincinnati, Ohio, 45212
Clinical Research of South Florida
Coral Gables, Florida, 33134
Wesley Neurology Clinic Pc (Multiple Sclerosis)
Cordova, Tennessee, 38018
InSite Clinical Research
DeSoto, Texas, 75115
Ohio Sleep Medicine Institue
Dublin, Ohio, 43017
Fleming Island Center for Clinical Research
Fleming Island, Florida, 32003
Precise Research Centers
Flowood, Mississippi, 39232
Garden City Asthma and Sleep Center
Garden City, New York, 11530
Sleep Disorders Center of the Mid-Atlantic
Glen Burnie, Maryland, 21061
Pulmonary Associates, Pa
Glendale, Arizona, 85306
Research Carolina of Hickory
Hickory, North Carolina, 28601
Hawaii Pacific Neurosciences
Honolulu, Hawaii, 96817
Jacksonville Center for Clinical Research
Jacksonville, Texas, 32216
Innovative Clinical Research
Lafayette, Colorado, 80026
Rowe Neurology Institute
Lenexa, Kansas, 66214
Clinical Trials Research
Lincoln, Florida, 95648
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205
Woodland International Research Group
Little Rock, Arkansas, 72211
Sleep Practitioners, LLC
Macon, Georgia, 31210
Cleveland Sleep Research Center
Middleburg Heights, Ohio, 44130
Saltzer Clinical Research
Nampa, Idaho, 83686
Neurocare Inc.
Newton, Massachusetts, 02459
Brian Abaluck LLC
Paoli, Pennsylvania, 19301
Wake Research Associates
Raleigh, North Carolina, 27612
Artemis Institute For Clinical Research - Riverside
Riverside, California, 92503
Pacific Research Network
San Diego, California, 92103
Artemis Institute for Clinical Research
San Marcos, California, 92078
Santa Monica Clinical Trials
Santa Monica, California, 90404
Clinical Research Group of St. Petersburgh
St. Petersburg, Florida, 33707
Dm Clinical Research / Martin Diagnostic Clinic
Tomball, Texas, 77375
Noble Clinical Research
Tucson, Arizona, 85704
Empire Clinical Research
Upland, California, 91786
Clinical Trials of America - NC, LLC
Winston-Salem, North Carolina, 27103
Robert V. Sibilia, MD, Inc.
Wooster, Ohio, 44691
Germany12 sites
Advanced Sleep Research GmbH
Berlin, 10117
Klinische Forschung Berlin-Mitte GmbH
Berlin, 10117
Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin Kompetenzzentrum Schlafmedizin
Berlin, 12200
Synexus Clinical Research GmbH
Bochum, 44787
Klinische Forschung Dresden GmbH
Dresden, 1069
Synexus Clinical Research GmbH
Frankfurt, 60313
Klinische Forschung Hannover Mitte GmbH
Hanover, 30159
Interdisziplinäre Schlafmedizin, Pfalzklinikum
Klingenmünster, 76889
Zentrum für Integrative Psychiatrie (ZiP) Universität zu Lübeck
Lübeck, 23538
Central Insitute of Mental Health Sleep laboratory Medical Faculty Mannheim/Heidelberg University
Mannheim, 68159
Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie der Universität am Bezirksklinikum Regensburg
Regensburg, 93053
SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
Schwerin, 19053
South Korea10 sites
Dong-A University Hospital
Busan, 49201
4F Neuroimaging analysis laboratory, 56 Dalseong-ro, Jung-gu
Daegu, 41931
Chungnam National University Hospital
Daejeon, 35015
3F, 2nd Building, Psychiatry Outpatient, Family Counseling Room, 42 Jebong-ro, Donggu
Gwangju, 61469
8F Sleep Lab, 1st Building,82, Gumi-ro 173 Beon-gil, Bundang-gu
Seongnam, 13620
3F Sleep Medicine Center, 101 Daehak-Ro Jongno-Gu
Seoul, 3080
1st CRC room, 2F, Jejoong building, 50-1 Yonsei-ro,, Seodaemun-gu
Seoul, 3722
B2F, Clinical Trial Center, Konkuk University Medical Center 120-1, Neungdong-ro, Gwangjin-gu
Seoul, 5030
B1F Neurological examination room, 892 Dongnam-ro, Gangdong-gu
Seoul, 5278
2F Psychiatry Outpatient, 93, Jungbu-daero, Paldal-gu
Suwon, 16247
Canada6 sites
Queensway Sleep Lab Sleep Clinic (MedSleep)- 5359 Dundas Street West, Suite 202, Etobicoke, ON M9B 1B1
Etobicoke, M9C 5N2
The Medical Arts Health Research Group
Kelowna, V1Y 3G8
Somni Research Inc.
Markham, L3R 1A3
Canadian Phase Onward Inc.
Toronto, Ontario, M3J 2C5
Somni Research, Calgary
Toronto, M3H 3W1
CANADIAN PHASE ONWARD INC. (Toronto)
Toronto, M3J 0K2
Belgium4 sites
HOSPITAL AZ SINT-JAN_Neurology department
Bruges, 8000
Hospital Universitair Zieknhuis Brussel, Pneumology and Sleep Laboratory
Brussels, 1090
University Hospital Gent, Department of General Internal Medicine and Center of neurophysiological Monitoring
Ghent, 9000
Hospital UZ Leuven_ Pneumology Department
Leuven, 3000
Finland4 sites
Vitalmed Uniklinikka
Helsinki, 380
Oivauni Oy - Kuopio
Kuopio, 70100
Oivauni Oy - Tampere
Tampere
Unitutkimusyksikkö, Turun Yliopisto
Turku
Sweden4 sites
Göteborgs Universitet, Centrum för sömn och vakenhetsstörningar
Gothenburg, 41390
Universitetssjukhuset Örebro Neurokliniken, Sömnenheten
Örebro, 70185
SOPHIAHEMMET (Stockholm)
Stockholm, 11486
Sömnutredningsmottagningen, smärtcentrum Akademiska sjukhuset
Uppsala, 75185
Czechia3 sites
Nemocnice České Budějovice, Centrum pro poruchy spánku a spánkovou medicínu
České Budějovice, 37087
Narodni Ustav Dusevniho Zdravi (National Institute of Mental Health)
Klecany
Fakultní nemocnice Ostrava, Spánková laboratoř
Ostrava-Poruba, 70852
France3 sites
CHRU De Lille - Hospital Salengro - Neurophysiologie Clinique
Lille, 59037
Clinique beau soleil - Department Sleep and Neurology
Montpellier
CHU NIMES - Unité de Sommeil
Nîmes, 30029
Hungary2 sites
Magyar Honvédség Egészségügyi Központ, Neurológiai Osztály
Budapest, 1134
Somnius Kft. SomnoCenter Szeged
Szeged, 6725
About this study
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
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.
- Conditions
- Insomnia Disorder
- Being tested
- Daridorexant, Placebo
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaridorexantDrug
Daridorexant will be administered as tablets, orally, once daily in the evening.
PlaceboOther
Matching placebo will be administered as tablets, orally, once daily in the evening.
| Study group | Role | What they receive |
|---|---|---|
| Daridorexant 10 mg | Experimental | Not described Receives: Drug: Daridorexant |
| Daridorexant 25 mg | Experimental | Not described Receives: Drug: Daridorexant |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
"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.
Measured: 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)
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.
Measured: 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
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.
Measured: From baseline to Month 1 (i.e. for up to 1 month)
Change From Baseline to Month 3 in IDSIQ Sleepiness Domain Score
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.
Measured: From baseline to Month 3 (i.e. for up to 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start29 May 2018
- Primary completion9 Apr 2020
- Study completion14 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Insomnia DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 924 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Idorsia Pharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575104
- Sponsor's protocol ID
- ID-078A302
- Status last verified
- Mar 2022
- First submitted
- 17 May 2018
- Last updated
- 25 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33131027Mignot 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.
PubMed 35065036Pathmanathan J, Little D, Sadeghi K, Di Marco T, Kleinschmidt D, Nerrie J, Tjiptarto N, Arslan A, Hubbard J, Olivieri A, Puryear CB, Brandon Westover M, Donoghue J. The Insomnia EEG Score: a new tool for the classification of people with poor sleep. Sleep. 2026 Apr 16;49(4):zsaf353. doi: 10.1093/sleep/zsaf353.
PubMed 41217192Di 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.
PubMed 38644625Citrome 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.
PubMed 37796657Dutta 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.
PubMed 37526060Heidenreich 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.
PubMed 36054921
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03575104
- Acronym / sponsor ID
- ID-078A302
- Conditions
- Insomnia Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 924 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 May 2018 (actual)
- Primary completion
- 9 Apr 2020 (actual)
- Study completion
- 14 May 2020 (actual)
- First posted
- 2 Jul 2018 (actual)
- Results
- Posted 25 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Daridorexant 10 mg | Experimental | Drug: Daridorexant |
| Daridorexant 25 mg | Experimental | Drug: Daridorexant |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DaridorexantDaridorexant will be administered as tablets, orally, once daily in the evening. | Drug | Daridorexant 10 mg, Daridorexant 25 mg |
| PlaceboMatching placebo will be administered as tablets, orally, once daily in the evening. | Other | Placebo |
Primary outcome
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.
4 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33131027Hudgens 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.
- Results publication: PubMed 35065036Mignot 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.
- Derived from this study: PubMed 41217192Pathmanathan J, Little D, Sadeghi K, Di Marco T, Kleinschmidt D, Nerrie J, Tjiptarto N, Arslan A, Hubbard J, Olivieri A, Puryear CB, Brandon Westover M, Donoghue J. The Insomnia EEG Score: a new tool for the classification of people with poor sleep. Sleep. 2026 Apr 16;49(4):zsaf353. doi: 10.1093/sleep/zsaf353.
- Derived from this study: PubMed 38644625Di 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.
- Derived from this study: PubMed 37796657Citrome 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.
- Derived from this study: PubMed 37526060Dutta 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.
- Derived from this study: PubMed 36054921Heidenreich 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Idorsia Pharmaceuticals Ltd.
86 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Daridorexant in people with Insomnia Disorder, run by Idorsia Pharmaceuticals Ltd. at 86 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 86 sites in United States, Germany, South Korea, Canada, Belgium and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03575104, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.