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Completed

NCT Number: NCT03679884

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

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

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Key information

Conditions

Insomnia Disorder Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital UZ Leuven_ Pneumology Department, Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Daridorexant 10 mg

Drug

Daridorexant 10 mg film-coated tablets

Daridorexant 25 mg

Drug

Daridorexant 25 mg film-coated tablets

Daridorexant 50 mg

Drug

Daridorexant 50 mg film-coated tablets

Placebo

Drug

Matching placebo film-coated tablets

Primary outcomes

  1. Total no. of Subjects With at Least One TEAE

    Time frame: 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".

Sponsors and collaborators

Lead sponsor

Idorsia Pharmaceuticals Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 21, 2018
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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