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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03679884
Recruitment Status : Completed
First Posted : September 21, 2018
Results First Posted : March 2, 2022
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

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

Condition or disease Intervention/treatment Phase
Insomnia Disorder Drug: Daridorexant 10 mg Drug: Daridorexant 25 mg Drug: Daridorexant 50 mg Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 804 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multi-center, double-blind, parallel-group, randomized, placebo-controlled, three doses, 40-week extension study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 9, 2018
Actual Primary Completion Date : February 22, 2021
Actual Study Completion Date : February 22, 2021

Arm Intervention/treatment
Experimental: Daridorexant 10 mg
Film-coated tablets administered orally, once daily in the evening
Drug: Daridorexant 10 mg
Daridorexant 10 mg film-coated tablets

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

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

Placebo Comparator: Placebo
Film-coated tablets administered orally, once daily in the evening
Drug: Placebo
Matching placebo film-coated tablets

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




Primary Outcome Measures :
  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".




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03679884


Locations
Show Show 106 study locations
Sponsors and Collaborators
Idorsia Pharmaceuticals Ltd.
Investigators
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Study Director: Clinical Trials Idorsia Pharmaceuticals Ltd.
  Study Documents (Full-Text)

Documents provided by Idorsia Pharmaceuticals Ltd.:
Study Protocol: Study Protocol  [PDF] February 17, 2020
Statistical Analysis Plan  [PDF] June 20, 2020

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Responsible Party: Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT03679884    
Other Study ID Numbers: ID-078A303
First Posted: September 21, 2018    Key Record Dates
Results First Posted: March 2, 2022
Last Update Posted: March 2, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders