CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 930 enrolled
Drug / intervention
Daridorexant 25 mg +2 moredrug
Likely dose
Daridorexant 25 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.

Search/NCT03545191
NCT03545191Phase 3Completed
CompareCT.gov

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

Idorsia Pharmaceuticals Ltd.·interventional·Posted Jun 4, 2018·Updated Mar 25, 2022

In Brief

A Phase 3 clinical trial evaluating Daridorexant 25 mg, Daridorexant 50 mg, and 1 other intervention for Insomnia Disorder. Completed, enrolled 930 participants across 81 sites in 10 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
CountriesAustralia, Canada, Denmark, Germany, Italy, Poland, Serbia, Spain, Switzerland, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJun 4, 2018
Enrollment StartJun 4, 2018
Primary CompletionJan 25, 2020
Study CompletionFeb 25, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 8.1 years ago

Interventions

Daridorexant 25 mgdrug

Daridorexant will be administered as tablets, orally, once daily in the evening.

Daridorexant 50 mgdrug

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.