Clinical trial NCT03679884: Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Insomnia Disorder
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2018-09-21
Enrollment: 804
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-center, double-blind, parallel-group, randomized, placebo-controlled, three doses, 40-week extension study
Primary purpose: TREATMENT

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


Eligibility criteria: 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).

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