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

PHASE3CompletedINTERVENTIONAL
Enrollment

804

Participants

Timeline

Start Date

October 9, 2018

Primary Completion Date

February 22, 2021

Study Completion Date

February 22, 2021

Conditions
Insomnia Disorder
Interventions
DRUG

Daridorexant 10 mg

Daridorexant 10 mg film-coated tablets

DRUG

Daridorexant 25 mg

Daridorexant 25 mg film-coated tablets

DRUG

Daridorexant 50 mg

Daridorexant 50 mg film-coated tablets

DRUG

Placebo

Matching placebo film-coated tablets

Trial Locations (106)

380

Vitalmed Uniklinikka, Helsinki

1004

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

1053

Scan Sleep Specialists, Copenhagen

1069

Klinische Forschung Dresden GmbH, Dresden

1134

Magyar Honvédség Egészségügyi Központ, Neurológiai Osztály, Budapest

1307

Klinik imd Poliklinik fur Neurochirurgie, Dresden

1407

Acibadem City Clinic Tokuda Hospital EAD, Sofia

3000

Hospital UZ Leuven_ Pneumology Department, Leuven

4103

Synexus Leipzig Research Centre, Leipzig

6725

Somnius Kft. SomnoCenter Szeged, Szeged

8017

Centro Médico Teknon - Medicina del Sueño, Barcelona

8035

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

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

10117

Klinische Forschung Berlin-Mitte GmbH, Berlin

10629

emovis GmbH, Berlin

12200

Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin Kompetenzzentrum Schlafmedizin, Berlin

12627

Synexus Berlin Research Centre, Berlin

16247

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

19053

SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH, Schwerin

19055

Kinische Forschung Schwerin GmbH, Schwerin

19301

Brian Abaluck LLC, Paoli

20251

Clinical Trial Center North GmbH & Co. KG, Hamburg

20253

Klinische Forschung Hamburg GmbH, Hamburg

20815

Helene Emsellem, MD, Chevy Chase

21061

Sleep Disorders Center of the Mid-Atlantic, Glen Burnie

22182

Sleep Disorders Centers of the Mid-Atlantic, Vienna

23538

Zentrum für Integrative Psychiatrie (ZiP) Universität zu Lübeck, Lübeck

27103

Clinical Trials of America - NC, LLC, Winston-Salem

28036

Instituto de Investigaciones del Sueno, Madrid

28078

Research Carolina of Huntersville, Huntersville

28562

Coastal Carolina Healthcare, New Bern

28601

Research Carolina of Hickory, Hickory

30029

CHU NIMES - Unité de Sommeil, Nîmes

30159

Klinische Forschung Hannover Mitte GmbH, Hanover

30342

Neurotrials Research Incorporated, Atlanta

31210

Sleep Practitioners, LLC, Macon

32003

Fleming Island Center for Clinical Research, Fleming Island

32216

Jacksonville Center for Clinical Research, Jacksonville

32789

Clinical Site Partners, LLC, Winter Park

33024

Research Centers of America, Hollywood

33126

BioMed Research Institute, Miami

33134

Clinical Research of South Florida, Coral Gables

33467

Canvas Clinical Research, LLC, Lake Worth

33511

PAB Clinical Research, Brandon

33707

Clinical Research Group of St. Petersburgh, St. Petersburg

33765

St. Francis Sleep Allergy and Lung Institute, Clearwater

34131

Studienzentrum Wilhelmshöhe GmbH, Kassel

35243

Pulmonary Associates of the Southeast/WCR, Birmingham

39232

Precise Research Centers, Flowood

41390

Göteborgs Universitet, Centrum för sömn och vakenhetsstörningar, Gothenburg

41931

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

43016

Aventiv Research Inc., Dublin

44130

Cleveland Sleep Research Center, Middleburg Heights

44787

Synexus Clinical Research GmbH, Bochum

45212

CTI Clinical Research II, Cincinnati

45255

CTI Clinical Research Center, Cincinnati

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

60313

Synexus Clinical Research GmbH, Frankfurt

68128

Barrett Clinic, La Vista

68159

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

70100

Oivauni Oy - Kuopio, Kuopio

70185

Universitetssjukhuset Örebro Neurokliniken, Sömnenheten, Örebro

72211

Preferred Research Partners, Inc, Little Rock

Woodland International Research Group, Little Rock

75115

InSite Clinical Research, DeSoto

75185

Sömnutredningsmottagningen, smärtcentrum Akademiska sjukhuset, Uppsala

76137

Klinische Forschung Karlsruhe GmbH, Karlsruhe

77521

Inquest Clinical Research, Baytown

78731

FutureSearch Trials of Neurology, LP, Austin

80026

Innovative Clinical Research, Lafayette

81675

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

83686

Saltzer Clinical Research, Nampa

85306

Pulmonary Associates, Pa, Glendale

85704

Noble Clinical Research, Tucson

89104

Clinical Research Center of Nevada, Las Vegas

90404

Santa Monica Clinical Trials, Santa Monica

90703

Core Healthcare Group, Cerritos

90806

Long Beach Clinical Trials, Long Beach

91786

Empire Clinical Research, Upland

92078

Artemis Institute for Clinical Research, San Marcos

92103

Artemis institute for Clinical Research, San Diego

Pacific Research Network, San Diego

92503

Artemis Institute For Clinical Research - Riverside, Riverside

92647

Marvel Clinical Research, Huntington Beach

93053

Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie der Universität am Bezirksklinikum Regensburg, Regensburg

95648

Clinical Trials Research, Lincoln

97301

Oregon Center for Clinical Investigations,Inc, Salem

98122

Swedish Medical Center, Seattle

02747

Infinity Medical Research, Inc., North Dartmouth

27604-1547

Wake Research Associates, Raleigh

02886

Omega Medical Research, Warwick

M9C 5N2

Queensway Sleep Lab Sleep Clinic (MedSleep), Etobicoke

V1Y 3G8

The Medical Arts Health Research Group, Kelowna

L3R 1A3

Somni Research Inc., Markham

G1J 2G2

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

M3J 0K2

CANADIAN PHASE ONWARD INC. (Toronto), Toronto

M4P 1P2

MedSleep, Toronto

M5G1N8

Jodha Tishon Inc., Toronto

Unknown

Oivauni Oy - Tampere, Tampere

Unitutkimusyksikkö, Turun Yliopisto, Turku

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