Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03679884




Registration number
NCT03679884
Ethics application status
Date submitted
19/09/2018
Date registered
21/09/2018
Date last updated
2/03/2022

Titles & IDs
Public title
Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
Scientific 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
Secondary ID [1] 0 0
ID-078A303
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 10 mg
Treatment: Drugs - Daridorexant 25 mg
Treatment: Drugs - Daridorexant 50 mg
Treatment: Drugs - Placebo

Experimental: Daridorexant 10 mg - Film-coated tablets administered orally, once daily in the evening

Experimental: Daridorexant 25 mg - Film-coated tablets administered orally, once daily in the evening

Experimental: Daridorexant 50 mg - Film-coated tablets administered orally, once daily in the evening

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

Experimental: Ex-Placebo Daridorexant 25 mg - Film-coated tablets administered orally, once daily in the evening


Treatment: Drugs: Daridorexant 10 mg
Daridorexant 10 mg film-coated tablets

Treatment: Drugs: Daridorexant 25 mg
Daridorexant 25 mg film-coated tablets

Treatment: Drugs: Daridorexant 50 mg
Daridorexant 50 mg film-coated tablets

Treatment: Drugs: Placebo
Matching placebo film-coated tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Total no. of Subjects With at Least One TEAE
Timepoint [1] 0 0
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.

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

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
9/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/02/2021
Sample size
Target
Accrual to date
Final
804
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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Alabama
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Arizona
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Arkansas
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California
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Massachusetts
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Mississippi
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Nebraska
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Texas
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Washington
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Belgium
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Leuven
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Sofia
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Etobicoke
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Hannover
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Karlsruhe
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Leipzig
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Lübeck
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München
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Schwerin
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Warendorf
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Budapest
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Hungary
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Szeged
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Daegu
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Suwon
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Gdansk
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Barcelona
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Madrid
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Vitoria-Gasteiz
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Göteborg
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Uppsala
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Örebro
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Wald

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/ct2/show/NCT03679884