At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 60 enrolled
Drug / intervention
Daridorexant +1 moredrug
Likely dose
Daridorexant 50 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.
A Multi-center, Double-blind, Randomized, Placebo-controlled, 2-way Cross-over Post Approval Study to Investigate the Efficacy of Daridorexant in Subjects With Insomnia and Comorbid Nocturia
In Brief
A Phase 4 clinical trial evaluating Daridorexant and Placebo for Insomnia Disorder and Nocturia. Completed, enrolled 60 participants across 16 sites in 3 countries.
Detailed Summary
A study to find out if daridorexant is safe and efficacious in patients with insomnia and comorbid nocturia
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia Disorder, Nocturia
CountriesGermany, Spain, United States
Collaborators--
Timeline
Phase 4CompletedFinished
2023202420252026
First PostedOct 2022
Enrollment StartFeb 2023
Primary CompletionApr 2024
Study CompletionApr 2024
TodayJul 2026
First PostedOct 27, 2022
Enrollment StartFeb 16, 2023
Primary CompletionApr 12, 2024
Study CompletionApr 18, 2024
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 3.7 years ago
Interventions
Daridorexantdrug
Daridorexant is available as oral film-coated tablets at a strength of 50 mg.
Placebodrug
Placebo matching daridorexant is provided as identical-looking oral tablets, formulated with the same inactive ingredients (excipients) as the active tablets.