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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.

Tracking Information
First Submitted Date  ICMJE September 19, 2018
First Posted Date  ICMJE September 21, 2018
Results First Submitted Date  ICMJE January 7, 2022
Results First Posted Date  ICMJE March 2, 2022
Last Update Posted Date March 2, 2022
Actual Study Start Date  ICMJE October 9, 2018
Actual Primary Completion Date February 22, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2022)
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".
Original Primary Outcome Measures  ICMJE
 (submitted: September 20, 2018)
  • Serious adverse events (SAEs) [ Time Frame: Duration for up to 45 weeks, i.e. from signed ICF up to 30 days after last dose of DB study treatment ]
  • Treatment-emergent adverse events (TEAEs) [ Time Frame: Duration for up to 45 weeks, i.e. from signed ICF up to 30 days after last dose of DB study treatment ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
Official Title  ICMJE 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
Brief Summary Study to assess the long term safety and tolerability of daridorexant in adult and elderly subjects suffering from difficulties to sleep
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Insomnia Disorder
Intervention  ICMJE
  • Drug: Daridorexant 10 mg
    Daridorexant 10 mg film-coated tablets
  • Drug: Daridorexant 25 mg
    Daridorexant 25 mg film-coated tablets
  • Drug: Daridorexant 50 mg
    Daridorexant 50 mg film-coated tablets
  • Drug: Placebo
    Matching placebo film-coated tablets
Study Arms  ICMJE
  • Experimental: Daridorexant 10 mg
    Film-coated tablets administered orally, once daily in the evening
    Intervention: Drug: Daridorexant 10 mg
  • Experimental: Daridorexant 25 mg
    Film-coated tablets administered orally, once daily in the evening
    Intervention: Drug: Daridorexant 25 mg
  • Experimental: Daridorexant 50 mg
    Film-coated tablets administered orally, once daily in the evening
    Intervention: Drug: Daridorexant 50 mg
  • Placebo Comparator: Placebo
    Film-coated tablets administered orally, once daily in the evening
    Intervention: Drug: Placebo
  • Experimental: Ex-Placebo Daridorexant 25 mg
    Film-coated tablets administered orally, once daily in the evening
    Intervention: Drug: Daridorexant 25 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 11, 2020)
804
Original Estimated Enrollment  ICMJE
 (submitted: September 20, 2018)
1260
Actual Study Completion Date  ICMJE February 22, 2021
Actual Primary Completion Date February 22, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Bulgaria,   Canada,   Denmark,   Finland,   France,   Germany,   Hungary,   Korea, Republic of,   Poland,   Spain,   Sweden,   Switzerland,   United States
Removed Location Countries Australia,   Czechia,   Italy,   Serbia
 
Administrative Information
NCT Number  ICMJE NCT03679884
Other Study ID Numbers  ICMJE ID-078A303
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Idorsia Pharmaceuticals Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Idorsia Pharmaceuticals Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Idorsia Pharmaceuticals Ltd.
PRS Account Idorsia Pharmaceuticals Ltd.
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP