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

Study Overview
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Brief Summary
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Study to assess the long term safety and tolerability of daridorexant in adult and elderly subjects suffering from difficulties to sleep

Official Title
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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

Conditions
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Insomnia Disorder

Intervention / Treatment
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* Drug: Daridorexant 10 mg
* Drug: Daridorexant 25 mg
* Drug: Daridorexant 50 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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. 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multi-center, double-blind, parallel-group, randomized, placebo-controlled, three doses, 40-week extension study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daridorexant 10 mg<br>Film-coated tablets administered orally, once daily in the evening | Drug: Daridorexant 10 mg<br>* Daridorexant 10 mg film-coated tablets<br>|
| Experimental: Daridorexant 25 mg<br>Film-coated tablets administered orally, once daily in the evening | Drug: Daridorexant 25 mg<br>* Daridorexant 25 mg film-coated tablets<br>|
| Experimental: Daridorexant 50 mg<br>Film-coated tablets administered orally, once daily in the evening | Drug: Daridorexant 50 mg<br>* Daridorexant 50 mg film-coated tablets<br>|
| Placebo Comparator: Placebo<br>Film-coated tablets administered orally, once daily in the evening | Drug: Placebo<br>* Matching placebo film-coated tablets<br>|
| Experimental: Ex-Placebo Daridorexant 25 mg<br>Film-coated tablets administered orally, once daily in the evening | Drug: Daridorexant 25 mg<br>* Daridorexant 25 mg film-coated tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total no. of Subjects With at Least One TEAE | The primary objective of the study was to assess the long-term safety and tolerability of 10, 25 and 50 mg daridorexant. The total no. of subjects with at least one TEAE is presented here; no statistical analysis was conducted. The full set of safety data is available in the Section Adverse events. | 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. |