Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03545191
Registration number
NCT03545191
Ethics application status
Date submitted
22/05/2018
Date registered
4/06/2018
Titles & IDs
Public title
Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
ID-078A301
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Insomnia Disorder
0
0
Query!
Condition category
Condition code
Neurological
0
0
0
0
Query!
Other neurological disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Daridorexant 25 mg
Treatment: Drugs - Daridorexant 50 mg
Other interventions - Placebo
Experimental: Daridorexant 25 mg -
Experimental: Daridorexant 50 mg -
Placebo comparator: Placebo -
Treatment: Drugs: Daridorexant 25 mg
Daridorexant will be administered as tablets, orally, once daily in the evening.
Treatment: Drugs: Daridorexant 50 mg
Daridorexant will be administered as tablets, orally, once daily in the evening.
Other interventions: Placebo
Matching placebo will be administered as tablets, orally, once daily in the evening.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance)
Query!
Assessment method [1]
0
0
"Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.
Query!
Timepoint [1]
0
0
From baseline to Month 1 (i.e. for up to 1 month)
Query!
Primary outcome [2]
0
0
Change From Baseline to Month 3 in Wake After Sleep Onset (WASO)
Query!
Assessment method [2]
0
0
"Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.
Query!
Timepoint [2]
0
0
From baseline to Month 3 (i.e. for up to 3 months)
Query!
Primary outcome [3]
0
0
Change From Baseline to Month 1 in Latency to Persistent Sleep (LPS) (Sleep Onset)
Query!
Assessment method [3]
0
0
"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.
Query!
Timepoint [3]
0
0
From baseline to Month 1 (i.e. for up to 1 month)
Query!
Primary outcome [4]
0
0
Change From Baseline to Month 3 in Latency to Persistent Sleep (LPS)
Query!
Assessment method [4]
0
0
"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.
Query!
Timepoint [4]
0
0
From baseline to Month 3 (i.e. for up to 3 months)
Query!
Secondary outcome [1]
0
0
Change From Baseline to Month 1 in the Subjective Total Sleep Time (sTST)
Query!
Assessment method [1]
0
0
"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.
Query!
Timepoint [1]
0
0
From baseline to Month 1 (i.e. for up to 1 month)
Query!
Secondary outcome [2]
0
0
Change From Baseline to Month 3 in the Subjective Total Sleep Time (sTST)
Query!
Assessment method [2]
0
0
"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.
Query!
Timepoint [2]
0
0
From baseline to Month 3 (i.e. for up to 3 months)
Query!
Secondary outcome [3]
0
0
Change From Baseline to Month 1 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Sleepiness Domain Score
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
From baseline to Month 1 (i.e. for up to 1 month)
Query!
Secondary outcome [4]
0
0
Change From Baseline to Month 3 in IDSIQ Sleepiness Domain Score
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
From baseline to Month 3 (i.e. for up to 3 months)
Query!
Eligibility
Key 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
4/06/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
25/02/2020
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
930
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Respiratory Clinical Trials - Adelaide
Query!
Recruitment hospital [2]
0
0
Genesis Sleep Care Queensland - Auchenflower
Query!
Recruitment hospital [3]
0
0
Melbourne Sleep Disorders Centre - East Melbourne
Query!
Recruitment hospital [4]
0
0
The Woolcock Institute of Medical Research - Glebe
Query!
Recruitment hospital [5]
0
0
Royal Melbourne Hospital, Department of Respiratory Medicine - Parkville
Query!
Recruitment hospital [6]
0
0
Gold Coast University Hospital, Respiratory Medicine and Sleep Services - Southport
Query!
Recruitment hospital [7]
0
0
Westmead Hospital, Department of Respiratory and Sleep Medicine - Westmead
Query!
Recruitment postcode(s) [1]
0
0
5065 - Adelaide
Query!
Recruitment postcode(s) [2]
0
0
4066 - Auchenflower
Query!
Recruitment postcode(s) [3]
0
0
3002 - East Melbourne
Query!
Recruitment postcode(s) [4]
0
0
2037 - Glebe
Query!
Recruitment postcode(s) [5]
0
0
3052 - Parkville
Query!
Recruitment postcode(s) [6]
0
0
4215 - Southport
Query!
Recruitment postcode(s) [7]
0
0
2145 - Westmead
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Indiana
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Kentucky
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Maryland
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Massachusetts
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Nebraska
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Nevada
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
New York
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
North Carolina
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Ohio
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Oregon
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Rhode Island
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
South Carolina
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Tennessee
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Texas
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Utah
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Virginia
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Washington
Query!
Country [22]
0
0
Canada
Query!
State/province [22]
0
0
Mississauga
Query!
Country [23]
0
0
Canada
Query!
State/province [23]
0
0
Quebec
Query!
Country [24]
0
0
Canada
Query!
State/province [24]
0
0
Toronto
Query!
Country [25]
0
0
Denmark
Query!
State/province [25]
0
0
København
Query!
Country [26]
0
0
Germany
Query!
State/province [26]
0
0
Berlin
Query!
Country [27]
0
0
Germany
Query!
State/province [27]
0
0
Hamburg
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Karlsruhe
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
Kassel
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Leipzig
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
München
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Schwerin
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Warendorf
Query!
Country [34]
0
0
Italy
Query!
State/province [34]
0
0
Milano
Query!
Country [35]
0
0
Italy
Query!
State/province [35]
0
0
Pavia
Query!
Country [36]
0
0
Italy
Query!
State/province [36]
0
0
Pisa
Query!
Country [37]
0
0
Italy
Query!
State/province [37]
0
0
Torino
Query!
Country [38]
0
0
Poland
Query!
State/province [38]
0
0
Gdansk
Query!
Country [39]
0
0
Poland
Query!
State/province [39]
0
0
Warsaw
Query!
Country [40]
0
0
Poland
Query!
State/province [40]
0
0
Wroclaw
Query!
Country [41]
0
0
Serbia
Query!
State/province [41]
0
0
Belgrade
Query!
Country [42]
0
0
Serbia
Query!
State/province [42]
0
0
Novi Beograd
Query!
Country [43]
0
0
Spain
Query!
State/province [43]
0
0
Barcelona
Query!
Country [44]
0
0
Spain
Query!
State/province [44]
0
0
Castelló de la Plana
Query!
Country [45]
0
0
Spain
Query!
State/province [45]
0
0
Madrid
Query!
Country [46]
0
0
Spain
Query!
State/province [46]
0
0
Vitoria-Gasteiz
Query!
Country [47]
0
0
Spain
Query!
State/province [47]
0
0
Zaragoza
Query!
Country [48]
0
0
Switzerland
Query!
State/province [48]
0
0
Bad Zurzach
Query!
Country [49]
0
0
Switzerland
Query!
State/province [49]
0
0
Basel
Query!
Country [50]
0
0
Switzerland
Query!
State/province [50]
0
0
Bern
Query!
Country [51]
0
0
Switzerland
Query!
State/province [51]
0
0
Wald
Query!
Country [52]
0
0
Switzerland
Query!
State/province [52]
0
0
Wetzikon
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Idorsia Pharmaceuticals Ltd.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03545191
Query!
Trial related presentations / publications
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. 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 Mar;21(3):e3. doi: 10.1016/S1474-4422(22)00029-1. Lancet Neurol. 2022 Jun;21(6):e6. doi: 10.1016/S1474-4422(22)00144-2. 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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Trials
Query!
Address
0
0
Idorsia Pharmaceuticals Ltd.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/91/NCT03545191/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/91/NCT03545191/SAP_001.pdf
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Mignot E, Mayleben D, Fietze I, Leger D, Zammit G,...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT03545191