Trial Review

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/ct2/show/NCT03545191




Registration number
NCT03545191
Ethics application status
Date submitted
22/05/2018
Date registered
4/06/2018
Date last updated
25/03/2022

Titles & IDs
Public title
Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder
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
Secondary ID [1] 0 0
ID-078A301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia Disorder 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance)
Timepoint [1] 0 0
From baseline to Month 1 (i.e. for up to 1 month)
Primary outcome [2] 0 0
Change From Baseline to Month 3 in Wake After Sleep Onset (WASO)
Timepoint [2] 0 0
From baseline to Month 3 (i.e. for up to 3 months)
Primary outcome [3] 0 0
Change From Baseline to Month 1 in Latency to Persistent Sleep (LPS) (Sleep Onset)
Timepoint [3] 0 0
From baseline to Month 1 (i.e. for up to 1 month)
Primary outcome [4] 0 0
Change From Baseline to Month 3 in Latency to Persistent Sleep (LPS)
Timepoint [4] 0 0
From baseline to Month 3 (i.e. for up to 3 months)
Secondary outcome [1] 0 0
Change From Baseline to Month 1 in the Subjective Total Sleep Time (sTST)
Timepoint [1] 0 0
From baseline to Month 1 (i.e. for up to 1 month)
Secondary outcome [2] 0 0
Change From Baseline to Month 3 in the Subjective Total Sleep Time (sTST)
Timepoint [2] 0 0
From baseline to Month 3 (i.e. for up to 3 months)
Secondary outcome [3] 0 0
Change From Baseline to Month 1 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Sleepiness Domain Score
Timepoint [3] 0 0
From baseline to Month 1 (i.e. for up to 1 month)
Secondary outcome [4] 0 0
Change From Baseline to Month 3 in IDSIQ Sleepiness Domain Score
Timepoint [4] 0 0
From baseline to Month 3 (i.e. for up to 3 months)

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/02/2020
Sample size
Target
Accrual to date
Final
930
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Respiratory Clinical Trials - Adelaide
Recruitment hospital [2] 0 0
Genesis Sleep Care Queensland - Auchenflower
Recruitment hospital [3] 0 0
Melbourne Sleep Disorders Centre - East Melbourne
Recruitment hospital [4] 0 0
The Woolcock Institute of Medical Research - Glebe
Recruitment hospital [5] 0 0
Royal Melbourne Hospital, Department of Respiratory Medicine - Parkville
Recruitment hospital [6] 0 0
Gold Coast University Hospital, Respiratory Medicine and Sleep Services - Southport
Recruitment hospital [7] 0 0
Westmead Hospital, Department of Respiratory and Sleep Medicine - Westmead
Recruitment postcode(s) [1] 0 0
5065 - Adelaide
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment postcode(s) [4] 0 0
2037 - Glebe
Recruitment postcode(s) [5] 0 0
3052 - Parkville
Recruitment postcode(s) [6] 0 0
4215 - Southport
Recruitment postcode(s) [7] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
Nevada
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Rhode Island
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
Canada
State/province [22] 0 0
Mississauga
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
Canada
State/province [24] 0 0
Toronto
Country [25] 0 0
Denmark
State/province [25] 0 0
København
Country [26] 0 0
Germany
State/province [26] 0 0
Berlin
Country [27] 0 0
Germany
State/province [27] 0 0
Hamburg
Country [28] 0 0
Germany
State/province [28] 0 0
Karlsruhe
Country [29] 0 0
Germany
State/province [29] 0 0
Kassel
Country [30] 0 0
Germany
State/province [30] 0 0
Leipzig
Country [31] 0 0
Germany
State/province [31] 0 0
München
Country [32] 0 0
Germany
State/province [32] 0 0
Schwerin
Country [33] 0 0
Germany
State/province [33] 0 0
Warendorf
Country [34] 0 0
Italy
State/province [34] 0 0
Milano
Country [35] 0 0
Italy
State/province [35] 0 0
Pavia
Country [36] 0 0
Italy
State/province [36] 0 0
Pisa
Country [37] 0 0
Italy
State/province [37] 0 0
Torino
Country [38] 0 0
Poland
State/province [38] 0 0
Gdansk
Country [39] 0 0
Poland
State/province [39] 0 0
Warsaw
Country [40] 0 0
Poland
State/province [40] 0 0
Wroclaw
Country [41] 0 0
Serbia
State/province [41] 0 0
Belgrade
Country [42] 0 0
Serbia
State/province [42] 0 0
Novi Beograd
Country [43] 0 0
Spain
State/province [43] 0 0
Barcelona
Country [44] 0 0
Spain
State/province [44] 0 0
Castelló de la Plana
Country [45] 0 0
Spain
State/province [45] 0 0
Madrid
Country [46] 0 0
Spain
State/province [46] 0 0
Vitoria-Gasteiz
Country [47] 0 0
Spain
State/province [47] 0 0
Zaragoza
Country [48] 0 0
Switzerland
State/province [48] 0 0
Bad Zurzach
Country [49] 0 0
Switzerland
State/province [49] 0 0
Basel
Country [50] 0 0
Switzerland
State/province [50] 0 0
Bern
Country [51] 0 0
Switzerland
State/province [51] 0 0
Wald
Country [52] 0 0
Switzerland
State/province [52] 0 0
Wetzikon

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Idorsia Pharmaceuticals Ltd.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03545191
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.
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Idorsia Pharmaceuticals Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03545191