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

Insomnia Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03679884
• Other study ID #: ID-078A303
• Status: Completed
• Phase: Phase 3
• Start date: October 9, 2018
• Est. completion date: February 22, 2021

Study information

• Verified date: February 2022
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 804
• Est. completion date: February 22, 2021
• Est. primary completion date: February 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Insomnia Disorder
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Daridorexant 10 mg
Daridorexant 10 mg film-coated tablets
• Daridorexant 25 mg
Daridorexant 25 mg film-coated tablets
• Daridorexant 50 mg
Daridorexant 50 mg film-coated tablets
• Placebo
Matching placebo film-coated tablets

Locations

Country	Name	City	State
Belgium	Hospital UZ Leuven_ Pneumology Department	Leuven
Bulgaria	Acibadem City Clinic Tokuda Hospital EAD	Sofia
Canada	Queensway Sleep Lab Sleep Clinic (MedSleep)	Etobicoke
Canada	The Medical Arts Health Research Group	Kelowna
Canada	Somni Research Inc.	Markham
Canada	CRIUSMQ- CIUSSSCN, CETS (clinique du sommeil)	Quebec
Canada	CANADIAN PHASE ONWARD INC. (Toronto)	Toronto
Canada	Jodha Tishon Inc.	Toronto
Canada	MedSleep	Toronto
Denmark	Scan Sleep Specialists	København
Finland	Vitalmed Uniklinikka	Helsinki
Finland	Oivauni Oy - Kuopio	Kuopio
Finland	Oivauni Oy - Tampere	Tampere
Finland	Unitutkimusyksikkö, Turun Yliopisto	Turku
France	CHU NIMES - Unité de Sommeil	Nîmes
Germany	Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin Kompetenzzentrum Schlafmedizin	Berlin
Germany	emovis GmbH	Berlin
Germany	Klinische Forschung Berlin-Mitte GmbH	Berlin
Germany	St Hedwig-Krankenhaus, Klinik für Schlaf- und Chronomedizin	Berlin
Germany	Synexus Berlin Research Centre	Berlin
Germany	Synexus Clinical Research GmbH	Bochum
Germany	Klinik imd Poliklinik fur Neurochirurgie	Dresden
Germany	Klinische Forschung Dresden GmbH	Dresden
Germany	Synexus Clinical Research GmbH	Frankfurt
Germany	Clinical Trial Center North GmbH & Co. KG	Hamburg
Germany	Klinische Forschung Hamburg GmbH	Hamburg
Germany	Klinische Forschung Hannover Mitte GmbH	Hannover
Germany	Klinische Forschung Karlsruhe GmbH	Karlsruhe
Germany	Studienzentrum Wilhelmshöhe GmbH	Kassel
Germany	Synexus Leipzig Research Centre	Leipzig
Germany	Zentrum für Integrative Psychiatrie (ZiP) Universität zu Lübeck	Lübeck
Germany	Central Insitute of Mental Health Sleep laboratory Medical Faculty Mannheim/Heidelberg University	Mannheim
Germany	Klinikum Rechts der lsar TU München Dept. of Psychiatry and Psychotherapy	München
Germany	Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie der Universität am Bezirksklinikum Regensburg	Regensburg
Germany	Kinische Forschung Schwerin GmbH	Schwerin
Germany	SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH	Schwerin
Germany	ZMS Zentrum für medizinische Studien GmbH	Warendorf
Hungary	Magyar Honvédség Egészségügyi Központ, Neurológiai Osztály	Budapest
Hungary	Somnius Kft. SomnoCenter Szeged	Szeged
Korea, Republic of	4F Neuroimaging analysis laboratory, 56 Dalseong-ro, Jung-gu	Daegu
Korea, Republic of	2F Psychiatry Outpatient, 93, Jungbu-daero, Paldal-gu	Suwon
Poland	PI-House - Centrum Badan Klinicznych	Gdansk
Poland	Osrodek Medycyny Study Nurseu Instytutu Psychiatrii i Neurologii (Sleep Disorders Center)	Warsaw
Poland	EMC Instytut Medyczny SA, Przychodnia przy Lowieckiej	Wroclaw
Spain	Centro Médico Teknon - Medicina del Sueño	Barcelona
Spain	Hospital Universitari Vall d'Hebron - Neurophisiology Deparment - Sleep Unit	Barcelona
Spain	Instituto de Investigaciones del Sueno	Madrid
Spain	Hospital Universitario Araba - Unidad Funcional de Trastornos del Sueño	Vitoria-Gasteiz
Spain	Hospital MAZ - Neurophisiology and Sleep Department	Zaragoza
Sweden	Göteborgs Universitet, Centrum för sömn och vakenhetsstörningar	Göteborg
Sweden	Universitetssjukhuset Örebro Neurokliniken, Sömnenheten	Örebro
Sweden	Sömnutredningsmottagningen, smärtcentrum Akademiska sjukhuset	Uppsala
Switzerland	Zentrum für Schlafmedizin Zürcher Oberland, Zürcher RehaZentrum Wald	Wald
United States	Neurotrials Research Incorporated	Atlanta	Georgia
United States	FutureSearch Trials of Neurology, LP	Austin	Texas
United States	Inquest Clinical Research	Baytown	Texas
United States	Pulmonary Associates of the Southeast/WCR	Birmingham	Alabama
United States	PAB Clinical Research	Brandon	Florida
United States	Core Healthcare Group	Cerritos	California
United States	Helene Emsellem, MD	Chevy Chase	Maryland
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	CTI Clinical Research II	Cincinnati	Ohio
United States	St. Francis Sleep Allergy and Lung Institute	Clearwater	Florida
United States	Clinical Research of South Florida	Coral Gables	Florida
United States	InSite Clinical Research	DeSoto	Texas
United States	Aventiv Research Inc.	Dublin	Ohio
United States	Fleming Island Center for Clinical Research	Fleming Island	Florida
United States	Precise Research Centers	Flowood	Mississippi
United States	Sleep Disorders Center of the Mid-Atlantic	Glen Burnie	Maryland
United States	Pulmonary Associates, Pa	Glendale	Arizona
United States	Research Carolina of Hickory	Hickory	North Carolina
United States	Research Centers of America	Hollywood	Florida
United States	Research Carolina of Huntersville	Huntersville	North Carolina
United States	Marvel Clinical Research	Huntington Beach	California
United States	Jacksonville Center for Clinical Research	Jacksonville	Texas
United States	Barrett Clinic	La Vista	Nebraska
United States	Innovative Clinical Research	Lafayette	Colorado
United States	Canvas Clinical Research, LLC	Lake Worth	Florida
United States	Clinical Research Center of Nevada	Las Vegas	Nevada
United States	Clinical Trials Research	Lincoln	California
United States	Preferred Research Partners, Inc	Little Rock	Arkansas
United States	Woodland International Research Group	Little Rock	Arkansas
United States	Long Beach Clinical Trials	Long Beach	California
United States	Sleep Practitioners, LLC	Macon	Georgia
United States	BioMed Research Institute	Miami	Florida
United States	Cleveland Sleep Research Center	Middleburg Heights	Ohio
United States	Saltzer Clinical Research	Nampa	Idaho
United States	Coastal Carolina Healthcare	New Bern	North Carolina
United States	Clinilabs NYC	New York	New York
United States	Infinity Medical Research, Inc.	North Dartmouth	Massachusetts
United States	Brian Abaluck LLC	Paoli	Pennsylvania
United States	Wake Research Associates	Raleigh	North Carolina
United States	Artemis Institute For Clinical Research - Riverside	Riverside	California
United States	Clinical Research Group of St. Petersburgh	Saint Petersburg	Florida
United States	Oregon Center for Clinical Investigations,Inc	Salem	Oregon
United States	Artemis institute for Clinical Research	San Diego	California
United States	Pacific Research Network	San Diego	California
United States	Artemis Institute for Clinical Research	San Marcos	California
United States	Santa Monica Clinical Trials	Santa Monica	California
United States	Swedish Medical Center	Seattle	Washington
United States	Noble Clinical Research	Tucson	Arizona
United States	Empire Clinical Research	Upland	California
United States	Sleep Disorders Centers of the Mid-Atlantic	Vienna	Virginia
United States	Omega Medical Research	Warwick	Rhode Island
United States	Clinical Trials of America - NC, LLC	Winston-Salem	North Carolina
United States	Clinical Site Partners, LLC	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Canada,  Denmark,  Finland,  France,  Germany,  Hungary,  Korea, Republic of,  Poland,  Spain,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	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.