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

Phase 3

Completed

Interventions: Drug: Daridorexant 50 mg
Drug: Daridorexant 25 mg
Drug: Daridorexant 10 mg
Drug: Placebo

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

Recruitment & Eligibility

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).

Arm && Interventions

Group	Intervention	Description
Daridorexant 50 mg	Daridorexant 50 mg	Film-coated tablets administered orally, once daily in the evening
Ex-Placebo Daridorexant 25 mg	Daridorexant 25 mg	Film-coated tablets administered orally, once daily in the evening
Daridorexant 25 mg	Daridorexant 25 mg	Film-coated tablets administered orally, once daily in the evening
Daridorexant 10 mg	Daridorexant 10 mg	Film-coated tablets administered orally, once daily in the evening
Placebo	Placebo	Film-coated tablets administered orally, once daily in the evening

Primary Outcome Measures

Name	Time	Method
Total no. of Subjects With at Least One TEAE	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.	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".

Secondary Outcome Measures

Name	Time	Method

Locations (105): Pulmonary Associates of the Southeast/WCR
🇺🇸
Birmingham, Alabama, United States
Pulmonary Associates, Pa
🇺🇸
Glendale, Arizona, United States
Noble Clinical Research
🇺🇸
Tucson, Arizona, United States
Preferred Research Partners, Inc
🇺🇸
Little Rock, Arkansas, United States
Woodland International Research Group
🇺🇸
Little Rock, Arkansas, United States
Core Healthcare Group
🇺🇸
Cerritos, California, United States
Marvel Clinical Research
🇺🇸
Huntington Beach, California, United States
Clinical Trials Research
🇺🇸
Lincoln, California, United States
Long Beach Clinical Trials
🇺🇸
Long Beach, California, United States
Artemis Institute For Clinical Research - Riverside
🇺🇸
Riverside, California, United States
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Pulmonary Associates of the Southeast/WCR
🇺🇸Birmingham, Alabama, United States