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Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder

Primary Purpose

Insomnia Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
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;
  • Male or female aged ≥ 18 years;
  • Insomnia disorder according to DSM-5 criteria;
  • Insomnia Severity Index score ≥ 15;
  • Insufficient sleep quantity as collected subjectively in the sleep diary;
  • Women of childbearing potential must have a negative and urine pregnancy test and use the contraception scheme up to at least 30 days after last study treatment intake.

Exclusion Criteria:

  • Body mass index below 18.5 or above 40.0 kg/m2;
  • Any lifetime history of of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, narcolepsy, or apnea/ hypopnea;
  • Cognitive behavioral therapy (CBT) only allowed if, the treatment started at least 1 month prior to Visit 3 and the subject agrees to continue this CBT throughout the study;
  • Self-reported usual daytime napping ≥ 1 hour per day and ≥ 3 days per week;
  • Acute or unstable psychiatric conditions diagnosed by the Mini International Neuropsychiatric Interview;
  • Mini Mental State Examination (MMSE) score < 25 in subjects ≥ 50 years;
  • For female subjects: pregnant, lactating or planning to become pregnant during projected duration of the study;
  • History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments.
  • Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.

Sites / Locations

  • Pinnacle Research Group, LLC
  • Pulmonary Associates of the Southeast/WCR
  • Preferred Research Partners, Inc
  • Woodland Research Northwest
  • Marvel Clinical Research
  • Long Beach Clinical Trials
  • Artemis Institute for Clinical Research
  • PAB Clinical Research
  • St. Francis Sleep Allergy and Lung Institute
  • Innovative Clinical Research, Inc.
  • Research Centers of America
  • Canvas Clinical Research, LLC
  • BioMed Research Institute
  • Clinical Site Partners, LLC
  • LaPorte County Institute for Clinical Research
  • Kentucky Research Group
  • Helene Emsellem, MD
  • Infinity Medical Research, Inc.
  • Barrett Clinic
  • Clinical Research Center of Nevada
  • Clinilabs NYC
  • Research Carolina of Huntersville
  • Coastal Carolina Healthcare
  • CTI Clinical Research Center
  • Oregon Center for Clinical Investigations,Inc
  • BTC of Lincoln
  • Omega Medical Research
  • Bogan Sleep Consulting, LLC
  • Coastal Carolina Research Center
  • Tri-State Mountain Neurology
  • Inquest Clinical Research
  • Sleep Therapy & Research Center
  • Aspen Clinical Research
  • Pulmonary Associates of Richmond
  • Sleep Disorders Centers of the Mid-Atlantic
  • Swedish Medical Center
  • Respiratory Clinical Trials
  • Genesis Sleep Care Queensland
  • Melbourne Sleep Disorders Centre
  • The Woolcock Institute of Medical Research
  • Royal Melbourne Hospital, Department of Respiratory Medicine
  • Gold Coast University Hospital, Respiratory Medicine and Sleep Services
  • Westmead Hospital, Department of Respiratory and Sleep Medicine
  • Tri-Hospital Sleep Laboratory West
  • CRIUSMQ- CIUSSSCN, CETS (clinique du sommeil)
  • MedSleep
  • Jodha Tishon Inc.
  • Scan Sleep Specialists
  • St Hedwig-Krankenhaus, Klinik für Schlaf- und Chronomedizin
  • emovis GmbH
  • Synexus Berlin Research Centre
  • Clinical Trial Center North GmbH & Co. KG
  • Klinische Forschung Hamburg GmbH
  • Klinische Forschung Karlsruhe GmbH
  • Studienzentrum Wilhelmshöhe GmbH
  • Synexus Leipzig Research Centre
  • Klinikum Rechts der lsar TU München Dept. of Psychiatry and Psychotherapy
  • Kinische Forschung Schwerin GmbH
  • ZMS Zentrum für medizinische Studien GmbH
  • Ospedale San Raffaele - Centro per i Disturbi del Sonno San Raffaele - Ville-Turro - Pallazzina E
  • IRCCS FONDAZIONE Istituto Neurologico Nazionale "Casimiro Mondino" - Centro di Ricerca Interdipartimentale per la SSclerosi Multipla (CRISM) -
  • Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara - Centro di Medicina del Sonno - Clinica Neuroligica - Dipartimento de Neuroscienze
  • AOU Citta della Salute e della Scienza - Molinette - SSD Medicina del Sonno
  • PI-House - Centrum Badań Klinicznych
  • Ośrodek Medycyny Study Nurseu Instytutu Psychiatrii i Neurologii (Sleep Disorders Center)
  • EMC Instytut Medyczny SA, Przychodnia przy Łowieckiej
  • General Hospital Bel Medic, Center for Sleep disorders
  • Medigroup - Health Center Dr Ristic (MediGroup Dom zdravlja "Dr Ristic") - Neurology Department
  • Centro Médico Teknon - Medicina del Sueño
  • Hospital de La Santa Creu I Sant Pau
  • Hospital Universitari Vall d'Hebron - Neurophisiology Deparment - Sleep Unit
  • Hospital General de Castellon
  • Instituto de Investigaciones del Sueno
  • San Carlos University Hospital - Servicio de Neurofisiología Clínica
  • Hospital Universitario Araba - Unidad Funcional de Trastornos del Sueño
  • Hospital MAZ - Neurophisiology and Sleep Department
  • KSM Bad Zurzach, Klinik für Schlafmedizin
  • Universitäre Psychiatrische Kliniken Basel (Upk)
  • Universitätsklinik für Neurologie, Inselspital Bern, Schlaf-Wach-Epilepsie-Zentrum
  • Zentrum für Schlafmedizin Zürcher Oberland, Zürcher RehaZentrum Wald
  • Zentrum für Schlafmedizin GZO AG Spital Wetzikon

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Daridorexant 25 mg

Daridorexant 50 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance)
"Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.
Change From Baseline to Month 3 in Wake After Sleep Onset (WASO)
"Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.
Change From Baseline to Month 1 in Latency to Persistent Sleep (LPS) (Sleep Onset)
"Latency to Persistent Sleep" is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-awake, i.e., epochs scored as either sleep stage 1 (S1), sleep stage 2 (S2), sleep stage 3 (slow wave sleep) or REM, as determined by polysomnography.
Change From Baseline to Month 3 in Latency to Persistent Sleep (LPS)
"Latency to Persistent Sleep" is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-awake, i.e., epochs scored as either sleep stage 1 (S1), sleep stage 2 (S2), sleep stage 3 (slow wave sleep) or REM, as determined by polysomnography.

Secondary Outcome Measures

Change From Baseline to Month 1 in the Subjective Total Sleep Time (sTST)
"Subjective Total Sleep Time" is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in the subjective Total Sleep Time. A negative change from baseline indicates a decrease in subjective Total Sleep Time.
Change From Baseline to Month 3 in the Subjective Total Sleep Time (sTST)
"Subjective Total Sleep Time" is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in the subjective Total Sleep Time. A negative change from baseline indicates a decrease in subjective Total Sleep Time.
Change From Baseline to Month 1 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Sleepiness Domain Score
The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a validated patient reported outcome instrument comprising 14 items (each using a numeric rating scale from 0 to 10) grouped into three domains (i.e., sleepiness, mood, and alert/cognition) reflecting daytime impairment of insomnia. The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Change From Baseline to Month 3 in IDSIQ Sleepiness Domain Score
The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a validated patient reported outcome instrument comprising 14 items (each using a numeric rating scale from 0 to 10) grouped into three domains (i.e., sleepiness, mood, and alert/cognition) reflecting daytime impairment of insomnia. The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.

Full Information

First Posted
May 22, 2018
Last Updated
March 24, 2022
Sponsor
Idorsia Pharmaceuticals Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03545191
Brief Title
Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder
Official Title
Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Polysomnography Study to Assess the Efficacy and Safety of ACT-541468 in Adult and Elderly Subjects With Insomnia Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 4, 2018 (Actual)
Primary Completion Date
January 25, 2020 (Actual)
Study Completion Date
February 25, 2020 (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
The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.

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
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
930 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daridorexant 25 mg
Arm Type
Experimental
Arm Title
Daridorexant 50 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Daridorexant 25 mg
Intervention Description
Daridorexant will be administered as tablets, orally, once daily in the evening.
Intervention Type
Drug
Intervention Name(s)
Daridorexant 50 mg
Intervention Description
Daridorexant will be administered as tablets, orally, once daily in the evening.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matching placebo will be administered as tablets, orally, once daily in the evening.
Primary Outcome Measure Information:
Title
Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance)
Description
"Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.
Time Frame
From baseline to Month 1 (i.e. for up to 1 month)
Title
Change From Baseline to Month 3 in Wake After Sleep Onset (WASO)
Description
"Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.
Time Frame
From baseline to Month 3 (i.e. for up to 3 months)
Title
Change From Baseline to Month 1 in Latency to Persistent Sleep (LPS) (Sleep Onset)
Description
"Latency to Persistent Sleep" is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-awake, i.e., epochs scored as either sleep stage 1 (S1), sleep stage 2 (S2), sleep stage 3 (slow wave sleep) or REM, as determined by polysomnography.
Time Frame
From baseline to Month 1 (i.e. for up to 1 month)
Title
Change From Baseline to Month 3 in Latency to Persistent Sleep (LPS)
Description
"Latency to Persistent Sleep" is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-awake, i.e., epochs scored as either sleep stage 1 (S1), sleep stage 2 (S2), sleep stage 3 (slow wave sleep) or REM, as determined by polysomnography.
Time Frame
From baseline to Month 3 (i.e. for up to 3 months)
Secondary Outcome Measure Information:
Title
Change From Baseline to Month 1 in the Subjective Total Sleep Time (sTST)
Description
"Subjective Total Sleep Time" is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in the subjective Total Sleep Time. A negative change from baseline indicates a decrease in subjective Total Sleep Time.
Time Frame
From baseline to Month 1 (i.e. for up to 1 month)
Title
Change From Baseline to Month 3 in the Subjective Total Sleep Time (sTST)
Description
"Subjective Total Sleep Time" is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in the subjective Total Sleep Time. A negative change from baseline indicates a decrease in subjective Total Sleep Time.
Time Frame
From baseline to Month 3 (i.e. for up to 3 months)
Title
Change From Baseline to Month 1 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Sleepiness Domain Score
Description
The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a validated patient reported outcome instrument comprising 14 items (each using a numeric rating scale from 0 to 10) grouped into three domains (i.e., sleepiness, mood, and alert/cognition) reflecting daytime impairment of insomnia. The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Time Frame
From baseline to Month 1 (i.e. for up to 1 month)
Title
Change From Baseline to Month 3 in IDSIQ Sleepiness Domain Score
Description
The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a validated patient reported outcome instrument comprising 14 items (each using a numeric rating scale from 0 to 10) grouped into three domains (i.e., sleepiness, mood, and alert/cognition) reflecting daytime impairment of insomnia. The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Time Frame
From baseline to Month 3 (i.e. for up to 3 months)

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; Male or female aged ≥ 18 years; Insomnia disorder according to DSM-5 criteria; Insomnia Severity Index score ≥ 15; Insufficient sleep quantity as collected subjectively in the sleep diary; Women of childbearing potential must have a negative and urine pregnancy test and use the contraception scheme up to at least 30 days after last study treatment intake. Exclusion Criteria: Body mass index below 18.5 or above 40.0 kg/m2; Any lifetime history of of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, narcolepsy, or apnea/ hypopnea; Cognitive behavioral therapy (CBT) only allowed if, the treatment started at least 1 month prior to Visit 3 and the subject agrees to continue this CBT throughout the study; Self-reported usual daytime napping ≥ 1 hour per day and ≥ 3 days per week; Acute or unstable psychiatric conditions diagnosed by the Mini International Neuropsychiatric Interview; Mini Mental State Examination (MMSE) score < 25 in subjects ≥ 50 years; For female subjects: pregnant, lactating or planning to become pregnant during projected duration of the study; History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments. Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.
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
Pinnacle Research Group, LLC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Pulmonary Associates of the Southeast/WCR
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
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 Research Northwest
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Marvel Clinical Research
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
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
City
San Diego
State/Province
California
ZIP/Postal Code
92103
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
Innovative Clinical Research, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
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 Site Partners, LLC
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
LaPorte County Institute for Clinical Research
City
Michigan City
State/Province
Indiana
ZIP/Postal Code
46360
Country
United States
Facility Name
Kentucky Research Group
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40218
Country
United States
Facility Name
Helene Emsellem, MD
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Infinity Medical Research, Inc.
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
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 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
CTI Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
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
BTC of Lincoln
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Bogan Sleep Consulting, LLC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Tri-State Mountain Neurology
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
Inquest Clinical Research
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Facility Name
Sleep Therapy & Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Aspen Clinical Research
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States
Facility Name
Pulmonary Associates of Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
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
Respiratory Clinical Trials
City
Adelaide
ZIP/Postal Code
5065
Country
Australia
Facility Name
Genesis Sleep Care Queensland
City
Auchenflower
ZIP/Postal Code
4066
Country
Australia
Facility Name
Melbourne Sleep Disorders Centre
City
East Melbourne
ZIP/Postal Code
3002
Country
Australia
Facility Name
The Woolcock Institute of Medical Research
City
Glebe
ZIP/Postal Code
2037
Country
Australia
Facility Name
Royal Melbourne Hospital, Department of Respiratory Medicine
City
Parkville
ZIP/Postal Code
3052
Country
Australia
Facility Name
Gold Coast University Hospital, Respiratory Medicine and Sleep Services
City
Southport
ZIP/Postal Code
4215
Country
Australia
Facility Name
Westmead Hospital, Department of Respiratory and Sleep Medicine
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Facility Name
Tri-Hospital Sleep Laboratory West
City
Mississauga
ZIP/Postal Code
L5B 4M4
Country
Canada
Facility Name
CRIUSMQ- CIUSSSCN, CETS (clinique du sommeil)
City
Quebec
ZIP/Postal Code
G1J 2G2
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
St Hedwig-Krankenhaus, Klinik für Schlaf- und Chronomedizin
City
Berlin
ZIP/Postal Code
10115
Country
Germany
Facility Name
emovis GmbH
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
Synexus Berlin Research Centre
City
Berlin
ZIP/Postal Code
12627
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 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
Klinikum Rechts der lsar TU München Dept. of Psychiatry and Psychotherapy
City
München
ZIP/Postal Code
81675
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
Ospedale San Raffaele - Centro per i Disturbi del Sonno San Raffaele - Ville-Turro - Pallazzina E
City
Milano
ZIP/Postal Code
20127
Country
Italy
Facility Name
IRCCS FONDAZIONE Istituto Neurologico Nazionale "Casimiro Mondino" - Centro di Ricerca Interdipartimentale per la SSclerosi Multipla (CRISM) -
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara - Centro di Medicina del Sonno - Clinica Neuroligica - Dipartimento de Neuroscienze
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
AOU Citta della Salute e della Scienza - Molinette - SSD Medicina del Sonno
City
Torino
ZIP/Postal Code
10146
Country
Italy
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
General Hospital Bel Medic, Center for Sleep disorders
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Medigroup - Health Center Dr Ristic (MediGroup Dom zdravlja "Dr Ristic") - Neurology Department
City
Novi Beograd
ZIP/Postal Code
11070
Country
Serbia
Facility Name
Centro Médico Teknon - Medicina del Sueño
City
Barcelona
ZIP/Postal Code
8017
Country
Spain
Facility Name
Hospital de La Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
8025
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron - Neurophisiology Deparment - Sleep Unit
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hospital General de Castellon
City
Castelló de la Plana
ZIP/Postal Code
12004
Country
Spain
Facility Name
Instituto de Investigaciones del Sueno
City
Madrid
ZIP/Postal Code
28036
Country
Spain
Facility Name
San Carlos University Hospital - Servicio de Neurofisiología Clínica
City
Madrid
ZIP/Postal Code
28040
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
KSM Bad Zurzach, Klinik für Schlafmedizin
City
Bad Zurzach
ZIP/Postal Code
5330
Country
Switzerland
Facility Name
Universitäre Psychiatrische Kliniken Basel (Upk)
City
Basel
ZIP/Postal Code
4002
Country
Switzerland
Facility Name
Universitätsklinik für Neurologie, Inselspital Bern, Schlaf-Wach-Epilepsie-Zentrum
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Zentrum für Schlafmedizin Zürcher Oberland, Zürcher RehaZentrum Wald
City
Wald
ZIP/Postal Code
8636
Country
Switzerland
Facility Name
Zentrum für Schlafmedizin GZO AG Spital Wetzikon
City
Wetzikon
ZIP/Postal Code
8620
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33131027
Citation
Hudgens S, Phillips-Beyer A, Newton L, Seboek Kinter D, Benes H. Development and Validation of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). Patient. 2021 Mar;14(2):249-268. doi: 10.1007/s40271-020-00474-z. Epub 2020 Nov 1.
Results Reference
background
PubMed Identifier
35065036
Citation
Mignot E, Mayleben D, Fietze I, Leger D, Zammit G, Bassetti CLA, Pain S, Kinter DS, Roth T; investigators. Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo-controlled, phase 3 trials. Lancet Neurol. 2022 Feb;21(2):125-139. doi: 10.1016/S1474-4422(21)00436-1. Erratum In: Lancet Neurol. 2022 Jan 20;: Lancet Neurol. 2022 Jun;21(6):e6.
Results Reference
result
PubMed Identifier
36098936
Citation
Fietze I, Bassetti CLA, Mayleben DW, Pain S, Seboek Kinter D, McCall WV. Efficacy and Safety of Daridorexant in Older and Younger Adults with Insomnia Disorder: A Secondary Analysis of a Randomised Placebo-Controlled Trial. Drugs Aging. 2022 Oct;39(10):795-810. doi: 10.1007/s40266-022-00977-4. Epub 2022 Sep 13.
Results Reference
derived

Learn more about this trial

Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder

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