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

Primary Purpose

Insomnia Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Daridorexant 10 mg
Daridorexant 25 mg
Daridorexant 50 mg
Placebo
Sponsored by
Idorsia Pharmaceuticals Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Pulmonary Associates of the Southeast/WCR
  • Pulmonary Associates, Pa
  • Noble Clinical Research
  • Preferred Research Partners, Inc
  • Woodland International Research Group
  • Core Healthcare Group
  • Marvel Clinical Research
  • Clinical Trials Research
  • Long Beach Clinical Trials
  • Artemis Institute For Clinical Research - Riverside
  • Artemis institute for Clinical Research
  • Pacific Research Network
  • Artemis Institute for Clinical Research
  • Santa Monica Clinical Trials
  • Empire Clinical Research
  • Innovative Clinical Research
  • PAB Clinical Research
  • St. Francis Sleep Allergy and Lung Institute
  • Clinical Research of South Florida
  • Fleming Island Center for Clinical Research
  • Research Centers of America
  • Canvas Clinical Research, LLC
  • BioMed Research Institute
  • Clinical Research Group of St. Petersburgh
  • Clinical Site Partners, LLC
  • Neurotrials Research Incorporated
  • Sleep Practitioners, LLC
  • Saltzer Clinical Research
  • Helene Emsellem, MD
  • Sleep Disorders Center of the Mid-Atlantic
  • Infinity Medical Research, Inc.
  • Precise Research Centers
  • Barrett Clinic
  • Clinical Research Center of Nevada
  • Clinilabs NYC
  • Research Carolina of Hickory
  • Research Carolina of Huntersville
  • Coastal Carolina Healthcare
  • Wake Research Associates
  • Clinical Trials of America - NC, LLC
  • CTI Clinical Research II
  • CTI Clinical Research Center
  • Aventiv Research Inc.
  • Cleveland Sleep Research Center
  • Oregon Center for Clinical Investigations,Inc
  • Brian Abaluck LLC
  • Omega Medical Research
  • FutureSearch Trials of Neurology, LP
  • Inquest Clinical Research
  • InSite Clinical Research
  • Jacksonville Center for Clinical Research
  • Sleep Disorders Centers of the Mid-Atlantic
  • Swedish Medical Center
  • Hospital UZ Leuven_ Pneumology Department
  • Acibadem City Clinic Tokuda Hospital EAD
  • Queensway Sleep Lab Sleep Clinic (MedSleep)
  • The Medical Arts Health Research Group
  • Somni Research Inc.
  • CRIUSMQ- CIUSSSCN, CETS (clinique du sommeil)
  • CANADIAN PHASE ONWARD INC. (Toronto)
  • MedSleep
  • Jodha Tishon Inc.
  • Scan Sleep Specialists
  • Vitalmed Uniklinikka
  • Oivauni Oy - Kuopio
  • Oivauni Oy - Tampere
  • Unitutkimusyksikkö, Turun Yliopisto
  • CHU NIMES - Unité de Sommeil
  • St Hedwig-Krankenhaus, Klinik für Schlaf- und Chronomedizin
  • Klinische Forschung Berlin-Mitte GmbH
  • emovis GmbH
  • Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin Kompetenzzentrum Schlafmedizin
  • Synexus Berlin Research Centre
  • Synexus Clinical Research GmbH
  • Klinische Forschung Dresden GmbH
  • Klinik imd Poliklinik fur Neurochirurgie
  • Synexus Clinical Research GmbH
  • Clinical Trial Center North GmbH & Co. KG
  • Klinische Forschung Hamburg GmbH
  • Klinische Forschung Hannover Mitte GmbH
  • Klinische Forschung Karlsruhe GmbH
  • Studienzentrum Wilhelmshöhe GmbH
  • Synexus Leipzig Research Centre
  • Zentrum für Integrative Psychiatrie (ZiP) Universität zu Lübeck
  • Central Insitute of Mental Health Sleep laboratory Medical Faculty Mannheim/Heidelberg University
  • Klinikum Rechts der lsar TU München Dept. of Psychiatry and Psychotherapy
  • Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie der Universität am Bezirksklinikum Regensburg
  • SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
  • Kinische Forschung Schwerin GmbH
  • ZMS Zentrum für medizinische Studien GmbH
  • Magyar Honvédség Egészségügyi Központ, Neurológiai Osztály
  • Somnius Kft. SomnoCenter Szeged
  • 4F Neuroimaging analysis laboratory, 56 Dalseong-ro, Jung-gu
  • 2F Psychiatry Outpatient, 93, Jungbu-daero, Paldal-gu
  • PI-House - Centrum Badań Klinicznych
  • Ośrodek Medycyny Study Nurseu Instytutu Psychiatrii i Neurologii (Sleep Disorders Center)
  • EMC Instytut Medyczny SA, Przychodnia przy Łowieckiej
  • Centro Médico Teknon - Medicina del Sueño
  • Hospital Universitari Vall d'Hebron - Neurophisiology Deparment - Sleep Unit
  • Instituto de Investigaciones del Sueno
  • Hospital Universitario Araba - Unidad Funcional de Trastornos del Sueño
  • Hospital MAZ - Neurophisiology and Sleep Department
  • Göteborgs Universitet, Centrum för sömn och vakenhetsstörningar
  • Sömnutredningsmottagningen, smärtcentrum Akademiska sjukhuset
  • Universitetssjukhuset Örebro Neurokliniken, Sömnenheten
  • Zentrum für Schlafmedizin Zürcher Oberland, Zürcher RehaZentrum Wald

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

Daridorexant 10 mg

Daridorexant 25 mg

Daridorexant 50 mg

Placebo

Ex-Placebo Daridorexant 25 mg

Arm Description

Film-coated tablets administered orally, once daily in the evening

Film-coated tablets administered orally, once daily in the evening

Film-coated tablets administered orally, once daily in the evening

Film-coated tablets administered orally, once daily in the evening

Film-coated tablets administered orally, once daily in the evening

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

Full Information

First Posted
September 19, 2018
Last Updated
February 7, 2022
Sponsor
Idorsia Pharmaceuticals Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03679884
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 9, 2018 (Actual)
Primary Completion Date
February 22, 2021 (Actual)
Study Completion Date
February 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Idorsia Pharmaceuticals Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Multi-center, double-blind, parallel-group, randomized, placebo-controlled, three doses, 40-week extension study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
804 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daridorexant 10 mg
Arm Type
Experimental
Arm Description
Film-coated tablets administered orally, once daily in the evening
Arm Title
Daridorexant 25 mg
Arm Type
Experimental
Arm Description
Film-coated tablets administered orally, once daily in the evening
Arm Title
Daridorexant 50 mg
Arm Type
Experimental
Arm Description
Film-coated tablets administered orally, once daily in the evening
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Film-coated tablets administered orally, once daily in the evening
Arm Title
Ex-Placebo Daridorexant 25 mg
Arm Type
Experimental
Arm Description
Film-coated tablets administered orally, once daily in the evening
Intervention Type
Drug
Intervention Name(s)
Daridorexant 10 mg
Intervention Description
Daridorexant 10 mg film-coated tablets
Intervention Type
Drug
Intervention Name(s)
Daridorexant 25 mg
Intervention Description
Daridorexant 25 mg film-coated tablets
Intervention Type
Drug
Intervention Name(s)
Daridorexant 50 mg
Intervention Description
Daridorexant 50 mg film-coated tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo film-coated tablets
Primary Outcome Measure Information:
Title
Total no. of Subjects With at Least One TEAE
Description
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".
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Idorsia Pharmaceuticals Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Pulmonary Associates of the Southeast/WCR
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
Pulmonary Associates, Pa
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Noble Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Preferred Research Partners, Inc
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Woodland International Research Group
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Core Healthcare Group
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Marvel Clinical Research
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Clinical Trials Research
City
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Facility Name
Long Beach Clinical Trials
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Artemis Institute For Clinical Research - Riverside
City
Riverside
State/Province
California
ZIP/Postal Code
92503
Country
United States
Facility Name
Artemis institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Pacific Research Network
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
San Marcos
State/Province
California
ZIP/Postal Code
92078
Country
United States
Facility Name
Santa Monica Clinical Trials
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Empire Clinical Research
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Innovative Clinical Research
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States
Facility Name
PAB Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
St. Francis Sleep Allergy and Lung Institute
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Clinical Research of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Fleming Island Center for Clinical Research
City
Fleming Island
State/Province
Florida
ZIP/Postal Code
32003
Country
United States
Facility Name
Research Centers of America
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Canvas Clinical Research, LLC
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33467
Country
United States
Facility Name
BioMed Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Clinical Research Group of St. Petersburgh
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33707
Country
United States
Facility Name
Clinical Site Partners, LLC
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Neurotrials Research Incorporated
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Sleep Practitioners, LLC
City
Macon
State/Province
Georgia
ZIP/Postal Code
31210
Country
United States
Facility Name
Saltzer Clinical Research
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
Helene Emsellem, MD
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Sleep Disorders Center of the Mid-Atlantic
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
Infinity Medical Research, Inc.
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Barrett Clinic
City
La Vista
State/Province
Nebraska
ZIP/Postal Code
68128
Country
United States
Facility Name
Clinical Research Center of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
Facility Name
Clinilabs NYC
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Research Carolina of Hickory
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Research Carolina of Huntersville
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Coastal Carolina Healthcare
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27604-1547
Country
United States
Facility Name
Clinical Trials of America - NC, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
CTI Clinical Research II
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
CTI Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45255
Country
United States
Facility Name
Aventiv Research Inc.
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
Facility Name
Cleveland Sleep Research Center
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Oregon Center for Clinical Investigations,Inc
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Brian Abaluck LLC
City
Paoli
State/Province
Pennsylvania
ZIP/Postal Code
19301
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
FutureSearch Trials of Neurology, LP
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Inquest Clinical Research
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Facility Name
InSite Clinical Research
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Texas
ZIP/Postal Code
32216
Country
United States
Facility Name
Sleep Disorders Centers of the Mid-Atlantic
City
Vienna
State/Province
Virginia
ZIP/Postal Code
22182
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Hospital UZ Leuven_ Pneumology Department
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Acibadem City Clinic Tokuda Hospital EAD
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Queensway Sleep Lab Sleep Clinic (MedSleep)
City
Etobicoke
ZIP/Postal Code
M9C 5N2
Country
Canada
Facility Name
The Medical Arts Health Research Group
City
Kelowna
ZIP/Postal Code
V1Y 3G8
Country
Canada
Facility Name
Somni Research Inc.
City
Markham
ZIP/Postal Code
L3R 1A3
Country
Canada
Facility Name
CRIUSMQ- CIUSSSCN, CETS (clinique du sommeil)
City
Quebec
ZIP/Postal Code
G1J 2G2
Country
Canada
Facility Name
CANADIAN PHASE ONWARD INC. (Toronto)
City
Toronto
ZIP/Postal Code
M3J 0K2
Country
Canada
Facility Name
MedSleep
City
Toronto
ZIP/Postal Code
M4P 1P2
Country
Canada
Facility Name
Jodha Tishon Inc.
City
Toronto
ZIP/Postal Code
M5G1N8
Country
Canada
Facility Name
Scan Sleep Specialists
City
København
ZIP/Postal Code
1053
Country
Denmark
Facility Name
Vitalmed Uniklinikka
City
Helsinki
ZIP/Postal Code
380
Country
Finland
Facility Name
Oivauni Oy - Kuopio
City
Kuopio
ZIP/Postal Code
70100
Country
Finland
Facility Name
Oivauni Oy - Tampere
City
Tampere
Country
Finland
Facility Name
Unitutkimusyksikkö, Turun Yliopisto
City
Turku
Country
Finland
Facility Name
CHU NIMES - Unité de Sommeil
City
Nîmes
ZIP/Postal Code
30029
Country
France
Facility Name
St Hedwig-Krankenhaus, Klinik für Schlaf- und Chronomedizin
City
Berlin
ZIP/Postal Code
10115
Country
Germany
Facility Name
Klinische Forschung Berlin-Mitte GmbH
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
emovis GmbH
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin Kompetenzzentrum Schlafmedizin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Synexus Berlin Research Centre
City
Berlin
ZIP/Postal Code
12627
Country
Germany
Facility Name
Synexus Clinical Research GmbH
City
Bochum
ZIP/Postal Code
44787
Country
Germany
Facility Name
Klinische Forschung Dresden GmbH
City
Dresden
ZIP/Postal Code
1069
Country
Germany
Facility Name
Klinik imd Poliklinik fur Neurochirurgie
City
Dresden
ZIP/Postal Code
1307
Country
Germany
Facility Name
Synexus Clinical Research GmbH
City
Frankfurt
ZIP/Postal Code
60313
Country
Germany
Facility Name
Clinical Trial Center North GmbH & Co. KG
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Name
Klinische Forschung Hamburg GmbH
City
Hamburg
ZIP/Postal Code
20253
Country
Germany
Facility Name
Klinische Forschung Hannover Mitte GmbH
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Klinische Forschung Karlsruhe GmbH
City
Karlsruhe
ZIP/Postal Code
76137
Country
Germany
Facility Name
Studienzentrum Wilhelmshöhe GmbH
City
Kassel
ZIP/Postal Code
34131
Country
Germany
Facility Name
Synexus Leipzig Research Centre
City
Leipzig
ZIP/Postal Code
4103
Country
Germany
Facility Name
Zentrum für Integrative Psychiatrie (ZiP) Universität zu Lübeck
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Central Insitute of Mental Health Sleep laboratory Medical Faculty Mannheim/Heidelberg University
City
Mannheim
ZIP/Postal Code
68159
Country
Germany
Facility Name
Klinikum Rechts der lsar TU München Dept. of Psychiatry and Psychotherapy
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie der Universität am Bezirksklinikum Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
City
Schwerin
ZIP/Postal Code
19053
Country
Germany
Facility Name
Kinische Forschung Schwerin GmbH
City
Schwerin
ZIP/Postal Code
19055
Country
Germany
Facility Name
ZMS Zentrum für medizinische Studien GmbH
City
Warendorf
ZIP/Postal Code
48231
Country
Germany
Facility Name
Magyar Honvédség Egészségügyi Központ, Neurológiai Osztály
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Somnius Kft. SomnoCenter Szeged
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
4F Neuroimaging analysis laboratory, 56 Dalseong-ro, Jung-gu
City
Daegu
ZIP/Postal Code
41931
Country
Korea, Republic of
Facility Name
2F Psychiatry Outpatient, 93, Jungbu-daero, Paldal-gu
City
Suwon
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
PI-House - Centrum Badań Klinicznych
City
Gdańsk
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Ośrodek Medycyny Study Nurseu Instytutu Psychiatrii i Neurologii (Sleep Disorders Center)
City
Warsaw
ZIP/Postal Code
02-957
Country
Poland
Facility Name
EMC Instytut Medyczny SA, Przychodnia przy Łowieckiej
City
Wroclaw
ZIP/Postal Code
50220
Country
Poland
Facility Name
Centro Médico Teknon - Medicina del Sueño
City
Barcelona
ZIP/Postal Code
8017
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron - Neurophisiology Deparment - Sleep Unit
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Instituto de Investigaciones del Sueno
City
Madrid
ZIP/Postal Code
28036
Country
Spain
Facility Name
Hospital Universitario Araba - Unidad Funcional de Trastornos del Sueño
City
Vitoria-Gasteiz
ZIP/Postal Code
1004
Country
Spain
Facility Name
Hospital MAZ - Neurophisiology and Sleep Department
City
Zaragoza
ZIP/Postal Code
50015
Country
Spain
Facility Name
Göteborgs Universitet, Centrum för sömn och vakenhetsstörningar
City
Göteborg
ZIP/Postal Code
41390
Country
Sweden
Facility Name
Sömnutredningsmottagningen, smärtcentrum Akademiska sjukhuset
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Universitetssjukhuset Örebro Neurokliniken, Sömnenheten
City
Örebro
ZIP/Postal Code
70185
Country
Sweden
Facility Name
Zentrum für Schlafmedizin Zürcher Oberland, Zürcher RehaZentrum Wald
City
Wald
ZIP/Postal Code
8636
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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