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Study to Assess the Efficacy and Safety 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
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 and validated objectively by polysomnography;
  • 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

  • Pulmonary Associates, Pa
  • Noble Clinical Research
  • Baptist Health Center for Clinical Research
  • Woodland International Research Group
  • Core Healthcare Group
  • Artemis Institute For Clinical Research - Riverside
  • Pacific Research Network
  • Artemis Institute for Clinical Research
  • Santa Monica Clinical Trials
  • Empire Clinical Research
  • Innovative Clinical Research
  • Clinical Research of South Florida
  • Fleming Island Center for Clinical Research
  • Clinical Trials Research
  • Clinical Research Group of St. Petersburgh
  • Neurotrials Research Incorporated
  • Sleep Practitioners, LLC
  • Hawaii Pacific Neurosciences
  • Saltzer Clinical Research
  • Rowe Neurology Institute
  • Sleep Disorders Center of the Mid-Atlantic
  • Neurocare Inc.
  • Precise Research Centers
  • Garden City Asthma and Sleep Center
  • Research Carolina of Hickory
  • Wake Research Associates
  • Clinical Trials of America - NC, LLC
  • CTI Clinical Research II
  • Ohio Sleep Medicine Institue
  • Cleveland Sleep Research Center
  • Robert V. Sibilia, MD, Inc.
  • Brian Abaluck LLC
  • Wesley Neurology Clinic Pc (Multiple Sclerosis)
  • FutureSearch Trials of Neurology, LP
  • InSite Clinical Research
  • Jacksonville Center for Clinical Research
  • Dm Clinical Research / Martin Diagnostic Clinic
  • HOSPITAL AZ SINT-JAN_Neurology department
  • Hospital Universitair Zieknhuis Brussel, Pneumology and Sleep Laboratory
  • University Hospital Gent, Department of General Internal Medicine and Center of neurophysiological Monitoring
  • Hospital UZ Leuven_ Pneumology Department
  • Acibadem City Clinic Tokuda Hospital EAD
  • Canadian Phase Onward Inc.
  • Queensway Sleep Lab Sleep Clinic (MedSleep)- 5359 Dundas Street West, Suite 202, Etobicoke, ON M9B 1B1
  • The Medical Arts Health Research Group
  • Somni Research Inc.
  • Somni Research, Calgary
  • CANADIAN PHASE ONWARD INC. (Toronto)
  • Narodni Ustav Dusevniho Zdravi (National Institute of Mental Health)
  • Fakultní nemocnice Ostrava, Spánková laboratoř
  • Nemocnice České Budějovice, Centrum pro poruchy spánku a spánkovou medicínu
  • Vitalmed Uniklinikka
  • Oivauni Oy - Kuopio
  • Oivauni Oy - Tampere
  • Unitutkimusyksikkö, Turun Yliopisto
  • CHRU De Lille - Hospital Salengro - Neurophysiologie Clinique
  • Clinique beau soleil - Department Sleep and Neurology
  • CHU NIMES - Unité de Sommeil
  • Advanced Sleep Research GmbH
  • Klinische Forschung Berlin-Mitte GmbH
  • Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin Kompetenzzentrum Schlafmedizin
  • Synexus Clinical Research GmbH
  • Klinische Forschung Dresden GmbH
  • Synexus Clinical Research GmbH
  • Klinische Forschung Hannover Mitte GmbH
  • Interdisziplinäre Schlafmedizin, Pfalzklinikum
  • Zentrum für Integrative Psychiatrie (ZiP) Universität zu Lübeck
  • Central Insitute of Mental Health Sleep laboratory Medical Faculty Mannheim/Heidelberg University
  • Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie der Universität am Bezirksklinikum Regensburg
  • SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
  • Magyar Honvédség Egészségügyi Központ, Neurológiai Osztály
  • Somnius Kft. SomnoCenter Szeged
  • Dong-A University Hospital
  • 4F Neuroimaging analysis laboratory, 56 Dalseong-ro, Jung-gu
  • Chungnam National University Hospital
  • 3F, 2nd Building, Psychiatry Outpatient, Family Counseling Room, 42 Jebong-ro, Donggu
  • 8F Sleep Lab, 1st Building,82, Gumi-ro 173 Beon-gil, Bundang-gu
  • 3F Sleep Medicine Center, 101 Daehak-Ro Jongno-Gu
  • 1st CRC room, 2F, Jejoong building, 50-1 Yonsei-ro,, Seodaemun-gu
  • B2F, Clinical Trial Center, Konkuk University Medical Center 120-1, Neungdong-ro, Gwangjin-gu
  • B1F Neurological examination room, 892 Dongnam-ro, Gangdong-gu
  • 2F Psychiatry Outpatient, 93, Jungbu-daero, Paldal-gu
  • Göteborgs Universitet, Centrum för sömn och vakenhetsstörningar
  • SOPHIAHEMMET (Stockholm)
  • Sömnutredningsmottagningen, smärtcentrum Akademiska sjukhuset
  • Universitetssjukhuset Örebro Neurokliniken, Sömnenheten

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Daridorexant 10 mg

Daridorexant 25 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 17, 2018
Last Updated
March 24, 2022
Sponsor
Idorsia Pharmaceuticals Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03575104
Brief Title
Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
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
May 29, 2018 (Actual)
Primary Completion Date
April 9, 2020 (Actual)
Study Completion Date
May 14, 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
924 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daridorexant 10 mg
Arm Type
Experimental
Arm Title
Daridorexant 25 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Daridorexant
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 and validated objectively by polysomnography; 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
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
Baptist Health Center for Clinical Research
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
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
Artemis Institute For Clinical Research - Riverside
City
Riverside
State/Province
California
ZIP/Postal Code
92503
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
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
Clinical Trials Research
City
Lincoln
State/Province
Florida
ZIP/Postal Code
95648
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
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
Hawaii Pacific Neurosciences
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Saltzer Clinical Research
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
Rowe Neurology Institute
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
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
Neurocare Inc.
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Garden City Asthma and Sleep Center
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Research Carolina of Hickory
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
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
Ohio Sleep Medicine Institue
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43017
Country
United States
Facility Name
Cleveland Sleep Research Center
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Robert V. Sibilia, MD, Inc.
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
Brian Abaluck LLC
City
Paoli
State/Province
Pennsylvania
ZIP/Postal Code
19301
Country
United States
Facility Name
Wesley Neurology Clinic Pc (Multiple Sclerosis)
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
FutureSearch Trials of Neurology, LP
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
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
Dm Clinical Research / Martin Diagnostic Clinic
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
HOSPITAL AZ SINT-JAN_Neurology department
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Hospital Universitair Zieknhuis Brussel, Pneumology and Sleep Laboratory
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
University Hospital Gent, Department of General Internal Medicine and Center of neurophysiological Monitoring
City
Gent
ZIP/Postal Code
9000
Country
Belgium
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
Canadian Phase Onward Inc.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3J 2C5
Country
Canada
Facility Name
Queensway Sleep Lab Sleep Clinic (MedSleep)- 5359 Dundas Street West, Suite 202, Etobicoke, ON M9B 1B1
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
Somni Research, Calgary
City
Toronto
ZIP/Postal Code
M3H 3W1
Country
Canada
Facility Name
CANADIAN PHASE ONWARD INC. (Toronto)
City
Toronto
ZIP/Postal Code
M3J 0K2
Country
Canada
Facility Name
Narodni Ustav Dusevniho Zdravi (National Institute of Mental Health)
City
Klecany
Country
Czechia
Facility Name
Fakultní nemocnice Ostrava, Spánková laboratoř
City
Ostrava-Poruba
ZIP/Postal Code
70852
Country
Czechia
Facility Name
Nemocnice České Budějovice, Centrum pro poruchy spánku a spánkovou medicínu
City
České Budějovice
ZIP/Postal Code
37087
Country
Czechia
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
CHRU De Lille - Hospital Salengro - Neurophysiologie Clinique
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Clinique beau soleil - Department Sleep and Neurology
City
Montpellier
Country
France
Facility Name
CHU NIMES - Unité de Sommeil
City
Nîmes
ZIP/Postal Code
30029
Country
France
Facility Name
Advanced Sleep Research GmbH
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Klinische Forschung Berlin-Mitte GmbH
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin Kompetenzzentrum Schlafmedizin
City
Berlin
ZIP/Postal Code
12200
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
Synexus Clinical Research GmbH
City
Frankfurt
ZIP/Postal Code
60313
Country
Germany
Facility Name
Klinische Forschung Hannover Mitte GmbH
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Interdisziplinäre Schlafmedizin, Pfalzklinikum
City
Klingenmünster
ZIP/Postal Code
76889
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
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
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
Dong-A University Hospital
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
4F Neuroimaging analysis laboratory, 56 Dalseong-ro, Jung-gu
City
Daegu
ZIP/Postal Code
41931
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
3F, 2nd Building, Psychiatry Outpatient, Family Counseling Room, 42 Jebong-ro, Donggu
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
8F Sleep Lab, 1st Building,82, Gumi-ro 173 Beon-gil, Bundang-gu
City
Seongnam
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
3F Sleep Medicine Center, 101 Daehak-Ro Jongno-Gu
City
Seoul
ZIP/Postal Code
3080
Country
Korea, Republic of
Facility Name
1st CRC room, 2F, Jejoong building, 50-1 Yonsei-ro,, Seodaemun-gu
City
Seoul
ZIP/Postal Code
3722
Country
Korea, Republic of
Facility Name
B2F, Clinical Trial Center, Konkuk University Medical Center 120-1, Neungdong-ro, Gwangjin-gu
City
Seoul
ZIP/Postal Code
5030
Country
Korea, Republic of
Facility Name
B1F Neurological examination room, 892 Dongnam-ro, Gangdong-gu
City
Seoul
ZIP/Postal Code
5278
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
Göteborgs Universitet, Centrum för sömn och vakenhetsstörningar
City
Göteborg
ZIP/Postal Code
41390
Country
Sweden
Facility Name
SOPHIAHEMMET (Stockholm)
City
Stockholm
ZIP/Postal Code
11486
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

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

Learn more about this trial

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

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