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

• 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: Idorsia Pharmaceuticals Ltd.
• Information provided by (Responsible Party): Idorsia Pharmaceuticals Ltd.

Tracking Information

• First Submitted Date: September 19, 2018
• First Posted Date: September 21, 2018
• Results First Submitted Date: January 7, 2022
• Results First Posted Date: March 2, 2022
• Last Update Posted Date: March 2, 2022
• Actual Study Start Date: October 9, 2018
• Actual Primary Completion Date: February 22, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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: 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: Interventional
• Study Phase: Phase 3

Study Design

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: Insomnia Disorder

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 11, 2020): 804
• Original Estimated Enrollment (submitted: September 20, 2018): 1260
• Actual Study Completion Date: February 22, 2021
• Actual Primary Completion Date: February 22, 2021 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: 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: NCT03679884
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Idorsia Pharmaceuticals Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Idorsia Pharmaceuticals Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Trials; Idorsia Pharmaceuticals Ltd.

• PRS Account: Idorsia Pharmaceuticals Ltd.
• Verification Date: February 2022