At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 924 enrolled
Drug / intervention
Daridorexant +1 moredrug
Likely dose
Not stated in 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, Randomized, Placebo-controlled, Parallel-group, Polysomnography Study to Assess the Efficacy and Safety of ACT-541468 in Adult and Elderly Subjects With Insomnia Disorder
In Brief
A Phase 3 clinical trial evaluating Daridorexant and Placebo for Insomnia Disorder. Completed, enrolled 924 participants across 86 sites in 11 countries.
Detailed Summary
The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia Disorder
CountriesBelgium, Bulgaria, Canada, Czechia, Finland, France, Germany, Hungary, South Korea, Sweden, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
Enrollment StartMay 2018
First PostedJul 2018
Primary CompletionApr 2020
Study CompletionMay 2020
TodayJul 2026
First PostedJul 2, 2018
Enrollment StartMay 29, 2018
Primary CompletionApr 9, 2020
Study CompletionMay 14, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 8 years ago
Interventions
Daridorexantdrug
Daridorexant will be administered as tablets, orally, once daily in the evening.
Placeboother
Matching placebo will be administered as tablets, orally, once daily in the evening.