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Insomnia DisorderPhase 3NCT03679884

Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep

A Phase 3 study testing Daridorexant 10 mg, Daridorexant 25 mg and Daridorexant 50 mg in people with Insomnia Disorder, run by Idorsia Pharmaceuticals Ltd. at 106 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Study to assess the long term safety and tolerability of daridorexant in adult and elderly subjects suffering from difficulties to sleep 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 10 mg, Daridorexant 25 mg and Daridorexant 50 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
804 participants
Where
106 sitesin 14 countries
Study dates
9 Oct 2018to 22 Feb 2021
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 (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.

Who cannot join

  • 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).

Trial locations and contacts

106 sites in 14 countries.

106 sites in 14 countries

United States53 sites

  • Neurotrials Research Incorporated

    Atlanta, Georgia, 30342

  • FutureSearch Trials of Neurology, LP

    Austin, Texas, 78731

  • Inquest Clinical Research

    Baytown, Texas, 77521

  • Pulmonary Associates of the Southeast/WCR

    Birmingham, Alabama, 35243

  • PAB Clinical Research

    Brandon, Florida, 33511

  • Core Healthcare Group

    Cerritos, California, 90703

  • Helene Emsellem, MD

    Chevy Chase, Maryland, 20815

  • CTI Clinical Research II

    Cincinnati, Ohio, 45212

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45255

  • St. Francis Sleep Allergy and Lung Institute

    Clearwater, Florida, 33765

  • Clinical Research of South Florida

    Coral Gables, Florida, 33134

  • InSite Clinical Research

    DeSoto, Texas, 75115

  • Aventiv Research Inc.

    Dublin, Ohio, 43016

  • Fleming Island Center for Clinical Research

    Fleming Island, Florida, 32003

  • Precise Research Centers

    Flowood, Mississippi, 39232

  • 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

  • Research Centers of America

    Hollywood, Florida, 33024

  • Research Carolina of Huntersville

    Huntersville, North Carolina, 28078

  • Marvel Clinical Research

    Huntington Beach, California, 92647

  • Jacksonville Center for Clinical Research

    Jacksonville, Texas, 32216

  • Barrett Clinic

    La Vista, Nebraska, 68128

  • Innovative Clinical Research

    Lafayette, Colorado, 80026

  • Canvas Clinical Research, LLC

    Lake Worth, Florida, 33467

  • Clinical Research Center of Nevada

    Las Vegas, Nevada, 89104

  • Clinical Trials Research

    Lincoln, California, 95648

  • Preferred Research Partners, Inc

    Little Rock, Arkansas, 72211

  • Woodland International Research Group

    Little Rock, Arkansas, 72211

  • Long Beach Clinical Trials

    Long Beach, California, 90806

  • Sleep Practitioners, LLC

    Macon, Georgia, 31210

  • BioMed Research Institute

    Miami, Florida, 33126

  • Cleveland Sleep Research Center

    Middleburg Heights, Ohio, 44130

  • Saltzer Clinical Research

    Nampa, Idaho, 83686

  • Coastal Carolina Healthcare

    New Bern, North Carolina, 28562

  • Clinilabs NYC

    New York, New York, 10019

  • Infinity Medical Research, Inc.

    North Dartmouth, Massachusetts, 02747

  • Brian Abaluck LLC

    Paoli, Pennsylvania, 19301

  • Wake Research Associates

    Raleigh, North Carolina, 27604-1547

  • Artemis Institute For Clinical Research - Riverside

    Riverside, California, 92503

  • Oregon Center for Clinical Investigations,Inc

    Salem, Oregon, 97301

  • Artemis institute for Clinical Research

    San Diego, California, 92103

  • Pacific Research Network

    San Diego, California, 92103

  • Artemis Institute for Clinical Research

    San Marcos, California, 92078

  • Santa Monica Clinical Trials

    Santa Monica, California, 90404

  • Swedish Medical Center

    Seattle, Washington, 98122

  • Clinical Research Group of St. Petersburgh

    St. Petersburg, Florida, 33707

  • Noble Clinical Research

    Tucson, Arizona, 85704

  • Empire Clinical Research

    Upland, California, 91786

  • Sleep Disorders Centers of the Mid-Atlantic

    Vienna, Virginia, 22182

  • Omega Medical Research

    Warwick, Rhode Island, 02886

  • Clinical Trials of America - NC, LLC

    Winston-Salem, North Carolina, 27103

  • Clinical Site Partners, LLC

    Winter Park, Florida, 32789

Other trials in United States

Germany22 sites

  • St Hedwig-Krankenhaus, Klinik für Schlaf- und Chronomedizin

    Berlin, 10115

  • Klinische Forschung Berlin-Mitte GmbH

    Berlin, 10117

  • emovis GmbH

    Berlin, 10629

  • Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin Kompetenzzentrum Schlafmedizin

    Berlin, 12200

  • Synexus Berlin Research Centre

    Berlin, 12627

  • Synexus Clinical Research GmbH

    Bochum, 44787

  • Klinische Forschung Dresden GmbH

    Dresden, 1069

  • Klinik imd Poliklinik fur Neurochirurgie

    Dresden, 1307

  • Synexus Clinical Research GmbH

    Frankfurt, 60313

  • Clinical Trial Center North GmbH & Co. KG

    Hamburg, 20251

  • Klinische Forschung Hamburg GmbH

    Hamburg, 20253

  • Klinische Forschung Hannover Mitte GmbH

    Hanover, 30159

  • Klinische Forschung Karlsruhe GmbH

    Karlsruhe, 76137

  • Studienzentrum Wilhelmshöhe GmbH

    Kassel, 34131

  • Synexus Leipzig Research Centre

    Leipzig, 4103

  • Zentrum für Integrative Psychiatrie (ZiP) Universität zu Lübeck

    Lübeck, 23538

  • Central Insitute of Mental Health Sleep laboratory Medical Faculty Mannheim/Heidelberg University

    Mannheim, 68159

  • Klinikum Rechts der lsar TU München Dept. of Psychiatry and Psychotherapy

    München, 81675

  • 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

  • Kinische Forschung Schwerin GmbH

    Schwerin, 19055

  • ZMS Zentrum für medizinische Studien GmbH

    Warendorf, 48231

Other trials in Germany

Canada7 sites

  • Queensway Sleep Lab Sleep Clinic (MedSleep)

    Etobicoke, M9C 5N2

  • The Medical Arts Health Research Group

    Kelowna, V1Y 3G8

  • Somni Research Inc.

    Markham, L3R 1A3

  • CRIUSMQ- CIUSSSCN, CETS (clinique du sommeil)

    Québec, G1J 2G2

  • CANADIAN PHASE ONWARD INC. (Toronto)

    Toronto, M3J 0K2

  • MedSleep

    Toronto, M4P 1P2

  • Jodha Tishon Inc.

    Toronto, M5G1N8

Other trials in Canada

Spain5 sites

  • Centro Médico Teknon - Medicina del Sueño

    Barcelona, 8017

  • Hospital Universitari Vall d'Hebron - Neurophisiology Deparment - Sleep Unit

    Barcelona, 8035

  • Instituto de Investigaciones del Sueno

    Madrid, 28036

  • Hospital Universitario Araba - Unidad Funcional de Trastornos del Sueño

    Vitoria-Gasteiz, 1004

  • Hospital MAZ - Neurophisiology and Sleep Department

    Zaragoza, 50015

Other trials in Spain

Finland4 sites

  • Vitalmed Uniklinikka

    Helsinki, 380

  • Oivauni Oy - Kuopio

    Kuopio, 70100

  • Oivauni Oy - Tampere

    Tampere

  • Unitutkimusyksikkö, Turun Yliopisto

    Turku

Other trials in Finland

Poland3 sites

  • PI-House - Centrum Badań Klinicznych

    Gdansk, 80-546

  • Ośrodek Medycyny Study Nurseu Instytutu Psychiatrii i Neurologii (Sleep Disorders Center)

    Warsaw, 02-957

  • EMC Instytut Medyczny SA, Przychodnia przy Łowieckiej

    Wroclaw, 50220

Other trials in Poland

Sweden3 sites

  • Göteborgs Universitet, Centrum för sömn och vakenhetsstörningar

    Gothenburg, 41390

  • Universitetssjukhuset Örebro Neurokliniken, Sömnenheten

    Örebro, 70185

  • Sömnutredningsmottagningen, smärtcentrum Akademiska sjukhuset

    Uppsala, 75185

Other trials in Sweden

Hungary2 sites

  • Magyar Honvédség Egészségügyi Központ, Neurológiai Osztály

    Budapest, 1134

  • Somnius Kft. SomnoCenter Szeged

    Szeged, 6725

Other trials in Hungary

South Korea2 sites

  • 4F Neuroimaging analysis laboratory, 56 Dalseong-ro, Jung-gu

    Daegu, 41931

  • 2F Psychiatry Outpatient, 93, Jungbu-daero, Paldal-gu

    Suwon, 16247

Other trials in South Korea

Belgium1 site

  • Hospital UZ Leuven_ Pneumology Department

    Leuven, 3000

Other trials in Belgium

Bulgaria1 site

  • Acibadem City Clinic Tokuda Hospital EAD

    Sofia, 1407

Other trials in Bulgaria

Denmark1 site

  • Scan Sleep Specialists

    Copenhagen, 1053

Other trials in Denmark

France1 site

  • CHU NIMES - Unité de Sommeil

    Nîmes, 30029

Other trials in France

Switzerland1 site

  • Zentrum für Schlafmedizin Zürcher Oberland, Zürcher RehaZentrum Wald

    Wald, 8636

Other trials in Switzerland

About this study

Official title: 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

Study to assess the long term safety and tolerability of daridorexant in adult and elderly subjects suffering from difficulties to sleep

Being tested
Daridorexant 10 mg, Daridorexant 25 mg, Daridorexant 50 mg, 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.

  • Daridorexant 10 mgDrug

    Daridorexant 10 mg film-coated tablets

  • Daridorexant 25 mgDrug

    Daridorexant 25 mg film-coated tablets

  • Daridorexant 50 mgDrug

    Daridorexant 50 mg film-coated tablets

  • PlaceboDrug

    Matching placebo film-coated tablets

Study groups in NCT03679884
Study groupRoleWhat they receive
Daridorexant 10 mgExperimentalFilm-coated tablets administered orally, once daily in the evening
Receives: Drug: Daridorexant 10 mg
Daridorexant 25 mgExperimentalFilm-coated tablets administered orally, once daily in the evening
Receives: Drug: Daridorexant 25 mg
Daridorexant 50 mgExperimentalFilm-coated tablets administered orally, once daily in the evening
Receives: Drug: Daridorexant 50 mg
PlaceboPlacebo comparatorFilm-coated tablets administered orally, once daily in the evening
Receives: Drug: Placebo
Ex-Placebo Daridorexant 25 mgExperimentalFilm-coated tablets administered orally, once daily in the evening
Receives: Drug: Daridorexant 25 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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".

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2018
  2. Study start9 Oct 2018
  3. Primary completion22 Feb 2021
  4. Study completion22 Feb 2021

Resources

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
Model description
Multi-center, double-blind, parallel-group, randomized, placebo-controlled, three doses, 40-week extension study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
804 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03679884
Sponsor's protocol ID
ID-078A303
Status last verified
Feb 2022
First submitted
19 Sep 2018
Last updated
2 Mar 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37526060

  • Kunz 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.

    PubMed 36484969

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Daridorexant 10 mg, Daridorexant 25 mg and Daridorexant 50 mg in people with Insomnia Disorder, run by Idorsia Pharmaceuticals Ltd. at 106 sites in 14 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 5 inclusion and 3 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 2 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 106 sites in United States, Germany, Canada, Spain, Finland and 9 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 2 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?

Total no. of Subjects With at Least One TEAE (time frame: 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.). 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 NCT03679884, which also lists 2 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 2 Mar 2022.

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