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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:
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 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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Leuven
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Szeged
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Daegu
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Suwon
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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
Study to assess the long term safety and tolerability of daridorexant in adult and elderly
subjects suffering from difficulties to sleep
Trial website
https://clinicaltrials.gov/ct2/show/NCT03679884
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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
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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/NCT03679884