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

PHASE3CompletedINTERVENTIONAL
Enrollment

924

Participants

Timeline

Start Date

May 29, 2018

Primary Completion Date

April 9, 2020

Study Completion Date

May 14, 2020

Conditions
Insomnia Disorder
Interventions
DRUG

Daridorexant

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 (86)

380

Vitalmed Uniklinikka, Helsinki

1069

Klinische Forschung Dresden GmbH, Dresden

1090

Hospital Universitair Zieknhuis Brussel, Pneumology and Sleep Laboratory, Brussels

1134

Magyar Honvédség Egészségügyi Központ, Neurológiai Osztály, Budapest

1407

Acibadem City Clinic Tokuda Hospital EAD, Sofia

3000

Hospital UZ Leuven_ Pneumology Department, Leuven

3080

3F Sleep Medicine Center, 101 Daehak-Ro Jongno-Gu, Seoul

3722

1st CRC room, 2F, Jejoong building, 50-1 Yonsei-ro,, Seodaemun-gu, Seoul

5030

B2F, Clinical Trial Center, Konkuk University Medical Center 120-1, Neungdong-ro, Gwangjin-gu, Seoul

5278

B1F Neurological examination room, 892 Dongnam-ro, Gangdong-gu, Seoul

6725

Somnius Kft. SomnoCenter Szeged, Szeged

8000

HOSPITAL AZ SINT-JAN_Neurology department, Bruges

9000

University Hospital Gent, Department of General Internal Medicine and Center of neurophysiological Monitoring, Ghent

10117

Advanced Sleep Research GmbH, Berlin

Klinische Forschung Berlin-Mitte GmbH, Berlin

11486

SOPHIAHEMMET (Stockholm), Stockholm

11530

Garden City Asthma and Sleep Center, Garden City

12200

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

13620

8F Sleep Lab, 1st Building,82, Gumi-ro 173 Beon-gil, Bundang-gu, Seongnam

16247

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

19053

SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH, Schwerin

19301

Brian Abaluck LLC, Paoli

21061

Sleep Disorders Center of the Mid-Atlantic, Glen Burnie

23538

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

27103

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

27612

Wake Research Associates, Raleigh

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

33134

Clinical Research of South Florida, Coral Gables

33707

Clinical Research Group of St. Petersburgh, St. Petersburg

35015

Chungnam National University Hospital, Daejeon

37087

Nemocnice České Budějovice, Centrum pro poruchy spánku a spánkovou medicínu, České Budějovice

38018

Wesley Neurology Clinic Pc (Multiple Sclerosis), Cordova

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

43017

Ohio Sleep Medicine Institue, Dublin

44130

Cleveland Sleep Research Center, Middleburg Heights

44691

Robert V. Sibilia, MD, Inc., Wooster

44787

Synexus Clinical Research GmbH, Bochum

45212

CTI Clinical Research II, Cincinnati

49201

Dong-A University Hospital, Busan

59037

CHRU De Lille - Hospital Salengro - Neurophysiologie Clinique, Lille

60313

Synexus Clinical Research GmbH, Frankfurt

61469

3F, 2nd Building, Psychiatry Outpatient, Family Counseling Room, 42 Jebong-ro, Donggu, Gwangju

66214

Rowe Neurology Institute, Lenexa

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

70852

Fakultní nemocnice Ostrava, Spánková laboratoř, Ostrava-Poruba

72205

Baptist Health Center for Clinical Research, Little Rock

72211

Woodland International Research Group, Little Rock

75115

InSite Clinical Research, DeSoto

75185

Sömnutredningsmottagningen, smärtcentrum Akademiska sjukhuset, Uppsala

76889

Interdisziplinäre Schlafmedizin, Pfalzklinikum, Klingenmünster

77375

Dm Clinical Research / Martin Diagnostic Clinic, Tomball

78731

FutureSearch Trials of Neurology, LP, Austin

80026

Innovative Clinical Research, Lafayette

83686

Saltzer Clinical Research, Nampa

85306

Pulmonary Associates, Pa, Glendale

85704

Noble Clinical Research, Tucson

90404

Santa Monica Clinical Trials, Santa Monica

90703

Core Healthcare Group, Cerritos

91786

Empire Clinical Research, Upland

92078

Artemis Institute for Clinical Research, San Marcos

92103

Pacific Research Network, San Diego

92503

Artemis Institute For Clinical Research - Riverside, Riverside

93053

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

95648

Clinical Trials Research, Lincoln

96817

Hawaii Pacific Neurosciences, Honolulu

02459

Neurocare Inc., Newton

M3J 2C5

Canadian Phase Onward Inc., Toronto

M9C 5N2

Queensway Sleep Lab Sleep Clinic (MedSleep)- 5359 Dundas Street West, Suite 202, Etobicoke, ON M9B 1B1, Etobicoke

V1Y 3G8

The Medical Arts Health Research Group, Kelowna

L3R 1A3

Somni Research Inc., Markham

M3H 3W1

Somni Research, Calgary, Toronto

M3J 0K2

CANADIAN PHASE ONWARD INC. (Toronto), Toronto

Unknown

Narodni Ustav Dusevniho Zdravi (National Institute of Mental Health), Klecany

Oivauni Oy - Tampere, Tampere

Unitutkimusyksikkö, Turun Yliopisto, Turku

Clinique beau soleil - Department Sleep and Neurology, Montpellier

Sponsors
All Listed Sponsors
lead

Idorsia Pharmaceuticals Ltd.

INDUSTRY