Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder

PHASE2RecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

September 6, 2022

Primary Completion Date

March 31, 2026

Study Completion Date

April 30, 2026

Conditions
Insomnia
Interventions
DRUG

Daridorexant 10 mg

Daridorexant will be taken orally, once daily in the evening during the treatment period.

DRUG

Daridorexant 25 mg

Daridorexant will be taken orally, once daily in the evening during the treatment period.

DRUG

Daridorexant 50 mg

Daridorexant will be taken orally, once daily in the evening during the treatment period.

DRUG

Placebo

Placebo will be taken orally, once daily in the evening during the treatment period.

Trial Locations (52)

508

NOT_YET_RECRUITING

"MHAT Heart and Brain (SJSC)", Pleven

1408

WITHDRAWN

MC Avitsena Ltd., Sofia

1618

RECRUITING

"MC Sun I Zdrave (Sleep and health) Ltd.", Sofia

1680

RECRUITING

MC Kalimat, Sofia

1784

RECRUITING

MC Inspiro, Sofia

2650

WITHDRAWN

University Hospital Antwerp (Department Pediatrics), Edegem

3320

RECRUITING

MC Zdrave 1 Ltd., Kozloduy

4001

RECRUITING

University Hospital (UMHAT) Sveti Georgi, Plovdiv

4031

RECRUITING

Universitäts-Kinderspital beider Basel (UKBB), Basel

6900

RECRUITING

Ospedale Regionale di Lugano Civico - Neurocentro della Svizzera Italiana, Sleep Medicine Unit, Lugano

7200

RECRUITING

MC ReSpiro Ltd., Razgrad

9000

WITHDRAWN

University Hospital Gent, Pediatric Sleep Center, Ghent

RECRUITING

MC Sanamedik Ltd., Varna

10117

RECRUITING

Advanced Sleep Research Berlin GmbH, Berlin

12203

RECRUITING

Charité -Universitätsmedizin Berlin, Berlin

16147

RECRUITING

Institute Giannina Gaslini, Genova

19053

RECRUITING

SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH, Schwerin

20142

WITHDRAWN

Ospedale San Paolo, Milan

23294

COMPLETED

National Clinical Research, Inc, Richmond

28046

WITHDRAWN

Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz, Madrid

28277

WITHDRAWN

OnSite Clinical Solutions, LLC, Charlotte

28938

RECRUITING

HM Puerta del Sur, Unidad del Sueño, Móstoles

29201

ACTIVE_NOT_RECRUITING

Bogan Sleep Consultants, LLC, Columbia

30030

WITHDRAWN

CenExel iResearch, LLC, Decatur

30281

COMPLETED

Clinical Research Institute, Stockbridge

30328

COMPLETED

NeuroTrials Research, Inc., Atlanta

32789

RECRUITING

Florida Pediatric Research Institute, Winter Park

33155

COMPLETED

D&H National Research Centers, Inc., Miami

33166

RECRUITING

Hope Research Network, Miami

33331

RECRUITING

Encore Medical Research of Weston, Weston

33511

RECRUITING

Teradan Clinical Trials, Brandon

33606

RECRUITING

University of South Florida - Tampa General Hospital (TGH), Tampa

40139

RECRUITING

IRCCS Ospedale Bellaria, Bologna

44106

WITHDRAWN

Rainbow Babies and Children's Hospital of University Hospitals, Cleveland

45711

RECRUITING

Vestische Caritas-Kliniken GmbH, Vestische Kinder- und Jugendklinik Datteln, Datteln

46010

RECRUITING

Hospital Quironsalud Valencia - Sleep Unit, Valencia

49008

WITHDRAWN

Western Michigan Homer Stryker M.D. School of Medicine, Kalamazoo

50139

RECRUITING

Meyer Children's Hospital, Florence

70124

WITHDRAWN

S.C. Neuropsichiatria Infantile, Bari

72211

RECRUITING

Preferred Research Partners, Inc., Little Rock

72703

WITHDRAWN

Preferred Research Partners NWA, LLC, Fayetteville

80333

RECRUITING

ProSomno, München

85724

RECRUITING

Banner - University Medical Center Tucson, Tucson

90027

WITHDRAWN

Children's Hospital Los Angeles, Los Angeles

91786

WITHDRAWN

Pacific Clinical Research Management Group LLC, Upland

09042

RECRUITING

Centro di Medicina del Sonno, Monserrato

00189

WITHDRAWN

Sapienza University, Roma

08017

WITHDRAWN

Centro Médico Teknon - Medicina del Sueño, Barcelona

08035

RECRUITING

Hospital Universitari Vall d'Hebron, Barcelona

08041

RECRUITING

Hospital de La Santa Creu I Sant Pau, Barcelona

08950

WITHDRAWN

Hospital Sant Joan de Deu, Barcelona

01004

RECRUITING

Hospital Universitario Araba, Vitoria-Gasteiz

Sponsors
All Listed Sponsors
lead

Idorsia Pharmaceuticals Ltd.

INDUSTRY