Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder

PHASE3CompletedINTERVENTIONAL
Enrollment

930

Participants

Timeline

Start Date

June 4, 2018

Primary Completion Date

January 25, 2020

Study Completion Date

February 25, 2020

Conditions
Insomnia Disorder
Interventions
DRUG

Daridorexant 25 mg

Daridorexant will be administered as tablets, orally, once daily in the evening.

DRUG

Daridorexant 50 mg

Daridorexant will be administered as tablets, orally, once daily in the evening.

OTHER

Placebo

Matching placebo will be administered as tablets, orally, once daily in the evening.

Trial Locations (81)

1004

Hospital Universitario Araba - Unidad Funcional de Trastornos del Sueño, Vitoria-Gasteiz

1053

Scan Sleep Specialists, Copenhagen

2037

The Woolcock Institute of Medical Research, Glebe

2145

Westmead Hospital, Department of Respiratory and Sleep Medicine, Westmead

3002

Melbourne Sleep Disorders Centre, East Melbourne

3010

Universitätsklinik für Neurologie, Inselspital Bern, Schlaf-Wach-Epilepsie-Zentrum, Bern

3052

Royal Melbourne Hospital, Department of Respiratory Medicine, Parkville

4002

Universitäre Psychiatrische Kliniken Basel (Upk), Basel

4066

Genesis Sleep Care Queensland, Auchenflower

4103

Synexus Leipzig Research Centre, Leipzig

4215

Gold Coast University Hospital, Respiratory Medicine and Sleep Services, Southport

5065

Respiratory Clinical Trials, Adelaide

5330

KSM Bad Zurzach, Klinik für Schlafmedizin, Bad Zurzach

8017

Centro Médico Teknon - Medicina del Sueño, Barcelona

8025

Hospital de La Santa Creu I Sant Pau, Barcelona

8035

Hospital Universitari Vall d'Hebron - Neurophisiology Deparment - Sleep Unit, Barcelona

8620

Zentrum für Schlafmedizin GZO AG Spital Wetzikon, Wetzikon

8636

Zentrum für Schlafmedizin Zürcher Oberland, Zürcher RehaZentrum Wald, Wald

10019

Clinilabs NYC, New York

10115

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

10146

AOU Citta della Salute e della Scienza - Molinette - SSD Medicina del Sonno, Torino

10629

emovis GmbH, Berlin

11000

General Hospital Bel Medic, Center for Sleep disorders, Belgrade

11070

"Medigroup - Health Center Dr Ristic (MediGroup Dom zdravlja Dr Ristic) - Neurology Department", New Belgrade

12004

Hospital General de Castellon, Castellon

12627

Synexus Berlin Research Centre, Berlin

19055

Kinische Forschung Schwerin GmbH, Schwerin

20127

Ospedale San Raffaele - Centro per i Disturbi del Sonno San Raffaele - Ville-Turro - Pallazzina E, Milan

20251

Clinical Trial Center North GmbH & Co. KG, Hamburg

20253

Klinische Forschung Hamburg GmbH, Hamburg

20815

Helene Emsellem, MD, Chevy Chase

22182

Sleep Disorders Centers of the Mid-Atlantic, Vienna

23225

Pulmonary Associates of Richmond, Richmond

27100

"IRCCS FONDAZIONE Istituto Neurologico Nazionale Casimiro Mondino - Centro di Ricerca Interdipartimentale per la SSclerosi Multipla (CRISM) -", Pavia

28036

Instituto de Investigaciones del Sueno, Madrid

28040

San Carlos University Hospital - Servicio de Neurofisiología Clínica, Madrid

28078

Research Carolina of Huntersville, Huntersville

28562

Coastal Carolina Healthcare, New Bern

29201

Bogan Sleep Consulting, LLC, Columbia

29464

Coastal Carolina Research Center, Mt. Pleasant

32789

Clinical Site Partners, LLC, Winter Park

33012

Innovative Clinical Research, Inc., Hialeah

33024

Research Centers of America, Hollywood

33126

BioMed Research Institute, Miami

33467

Canvas Clinical Research, LLC, Lake Worth

33511

PAB Clinical Research, Brandon

33765

St. Francis Sleep Allergy and Lung Institute, Clearwater

34131

Studienzentrum Wilhelmshöhe GmbH, Kassel

35243

Pulmonary Associates of the Southeast/WCR, Birmingham

36207

Pinnacle Research Group, LLC, Anniston

37604

Tri-State Mountain Neurology, Johnson City

40218

Kentucky Research Group, Louisville

45212

CTI Clinical Research Center, Cincinnati

46360

LaPorte County Institute for Clinical Research, Michigan City

48231

ZMS Zentrum für medizinische Studien GmbH, Warendorf

50015

Hospital MAZ - Neurophisiology and Sleep Department, Zaragoza

50220

EMC Instytut Medyczny SA, Przychodnia przy Łowieckiej, Wroclaw

56126

Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara - Centro di Medicina del Sonno - Clinica Neuroligica - Dipartimento de Neuroscienze, Pisa

68128

Barrett Clinic, La Vista

72211

Preferred Research Partners, Inc, Little Rock

72758

Woodland Research Northwest, Rogers

76137

Klinische Forschung Karlsruhe GmbH, Karlsruhe

77521

Inquest Clinical Research, Baytown

78229

Sleep Therapy & Research Center, San Antonio

81675

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

84058

Aspen Clinical Research, Orem

89104

Clinical Research Center of Nevada, Las Vegas

90806

Long Beach Clinical Trials, Long Beach

92103

Artemis Institute for Clinical Research, San Diego

92647

Marvel Clinical Research, Huntington Beach

97301

Oregon Center for Clinical Investigations,Inc, Salem

98122

Swedish Medical Center, Seattle

02747

Infinity Medical Research, Inc., North Dartmouth

02865

BTC of Lincoln, Lincoln

02886

Omega Medical Research, Warwick

L5B 4M4

Tri-Hospital Sleep Laboratory West, Mississauga

G1J 2G2

CRIUSMQ- CIUSSSCN, CETS (clinique du sommeil), Québec

M4P 1P2

MedSleep, Toronto

M5G1N8

Jodha Tishon Inc., Toronto

80-546

PI-House - Centrum Badań Klinicznych, Gdansk

02-957

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

Sponsors
All Listed Sponsors
lead

Idorsia Pharmaceuticals Ltd.

INDUSTRY