At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 804 enrolled
Drug / intervention
Daridorexant 10 mg +3 moredrug
Likely dose
Daridorexant 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Daridorexant 10 mg, Daridorexant 25 mg, and 2 other interventions for Insomnia Disorder. Completed, enrolled 804 participants across 106 sites in 14 countries.
Detailed Summary
Study to assess the long term safety and tolerability of daridorexant in adult and elderly subjects suffering from difficulties to sleep
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia Disorder
CountriesBelgium, Bulgaria, Canada, Denmark, Finland, France, Germany, Hungary, Poland, South Korea, Spain, Sweden, Switzerland, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedSep 2018
Enrollment StartOct 2018
Primary CompletionFeb 2021
TodayJul 2026
First PostedSep 21, 2018
Enrollment StartOct 9, 2018
Primary CompletionFeb 22, 2021
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 7.8 years ago
Interventions
Daridorexant 10 mgdrug
Daridorexant 10 mg film-coated tablets
Daridorexant 25 mgdrug
Daridorexant 25 mg film-coated tablets
Daridorexant 50 mgdrug
Daridorexant 50 mg film-coated tablets
Placebodrug
Matching placebo film-coated tablets